Clinical trial NCT04575467
Conditions: Subcutaneous Fat
Sponsor: Caliway Biopharmaceuticals Co., Ltd.
Start date: 2020-12-09; Completion date: 2021-12-08
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study. The primary objectives are to evaluate the safety and tolerability of injection lipolysis with CBL-514. It will be followed by a parallel-arm multiple-dose design in Stage 2.

Detailed description:

Arms: arm 1: CBL-514 will be administered via injection into the thigh subcutaneous adipose layer. arm 2: CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. arm 3: CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. arm 4: CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
Interventions: intervention 1: CBL-514
Intervention descriptions: intervention 1: CBL-514 will be administered via injection into the subcutaneous adipose layer.

Protocol documents:
Prot_002.pdf: 
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CLINICAL STUDY PROTOCOL 
 
STUDY TITLE: 
A 2-Stage Adaptive Design, Phase 2 Study to Evaluate 
the Efficacy, Safety and Tolerability of CBL-514 
Injection for Reducing Abdominal and Thigh 
Subcutaneous Fat 
PROTOCOL NUMBER: 
CBL-0202 
DEVELOPMENT PHASE: 
2 
STUDY DRUG: 
CBL-514 
INDICATION: 
Reducing subcutaneous fat in adults. 
SPONSOR: 
Caliway Biopharmaceuticals Australia Pty Ltd 
58 Gipps Street, Collingwood 
3066 Vic, Australia 
AUTHORS: 
 
 
 
 
 
 
 
 
CONFIDENTIAL 
Property of Caliway Biopharmaceuticals Australia Pty Ltd. – Confidential 
May not be used, divulged, published or otherwise disclosed without the consent of Caliway 
Biopharmaceuticals Australia Pty Ltd. 
 
 


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VERSION HISTORY 
 
Protocol 
Date 
Type of Amendment 
Protocol Version 1.3 
11 Nov 2020 
New protocol 
Protocol Version 2.0 
18 Jan 2021 
Amendment to Stage 2 of study design 
Protocol Version 3.1 
04 May 2021 
Amendment to treatment area  
(This version was submitted to Australia ethics 
committee only.) 
Protocol Version 3.2 
28 May 2021 
Substantial amendments to treatment area, study 
drug injection, and efficacy endpoint. 
(This version was submitted to US FDA only.) 
Protocol Version 4.0 
13Aug 2021 
Amendment to Stage 2 of study 
(This version was submitted to US FDA only.) 
Protocol Version 4.1 
09 Sep 2021 
Amendment to Stage 2 of study 
(This version was submitted to US Institutional 
Review Board only.) 
Protocol Version 5.0 
13 Oct 2021 
Amendment to Stage 2 of study 
(This version was submitted to US Institutional 
Review Board only.) 
Protocol Version 5.1 
20 Oct 2021 
Substantial amendment 
(This version was submitted to Australia ethics 
committee only.) 
Protocol Version 5.2 
12 Jan 2022 
Minor revisions to include further details in 
relation to position of the Reference point 
recording and IP administered surrounding the 
Reference point. Reference to Image Procedure 
manual also added. 
Protocol Version 6.0 
18 Jul 2022 
Substantial amendment 
Protocol Version 7.0 
23 Nov 2022 
Amendment to study endpoints 
Protocol Version 7.1 
17 Jan 2023 
Amendment to study  endpoints 
Protocol Version 8.0 
01 Mar 2023 
Amendment to study endpoints 


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PROTOCOL AUTHORIZATION 
 
Title: A 2-Stage Adaptive Design, Phase 2 Study to Evaluate the Efficacy, Safety and 
Tolerability of CBL-514 Injection for Reducing Abdominal and Thigh Subcutaneous Fat 
 
 
As Caliway Biopharmaceuticals Australia Pty Ltd. (“Sponsor”) representative, I confirm that the 
study protocol was subjected to critical review. The information it contains is consistent with 
current knowledge of the risks and benefits of the investigational product (IP), as well as with the 
moral, ethical, and scientific principles governing clinical research as set out in the current 
Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects) and 
the International Conference on Harmonisation guidelines on Good Clinical Practice (GCP). 
 
 
 
 
 
 
 
Signature 
 
 / Director 
 
Date 
Name / Title 
 
Caliway Biopharmaceuticals Australia Pty Ltd 
 
 
 


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INVESTIGATOR’S AGREEMENT 
Title: A 2-Stage Adaptive Design, Phase 2 Study to Evaluate the Efficacy, Safety and 
Tolerability of CBL 514 Injection for Reducing Abdominal and Thigh Subcutaneous Fat 
All documentation for this study that is supplied to me and that has not been previously 
published will be kept in the strictest confidence. This documentation includes this study 
protocol, Investigator's Brochure(s) (IB), electronic Case Report Forms (eCRFs), and other 
scientific data. 
The study will not be commenced without the prior written approval of a properly constituted 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC). No changes will be 
made to the study protocol without the prior written approval of the Sponsor and the Ethics 
Committee, except where necessary to avert an immediate hazard to the subjects. 
I have read the protocol and agree to conduct this trial in accordance with all stipulations of the 
protocol and in accordance with GCP guidelines, the Declaration of Helsinki, and local 
regulations (as applicable). 
I acknowledge that I am responsible for the overall study conduct. I agree to personally conduct 
or supervise the described clinical study. I agree to ensure that all associates, colleagues, and 
employees assisting in the conduct of the study at my site are informed about their obligations. 
Mechanisms are in place to ensure that site staff receive the appropriate information throughout 
the study. 
Investigator: 
Printed name 
Investigational Site: 
Signed: 
Date: 
Signature of Investigator 


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PROCEDURES IN CASE OF EMERGENCY 
 
Table 1: 
Emergency Contact Information 
Role in Study 
Name 
Address and Telephone Number 
Study Project Manager 
 
Caliway Biopharmaceuticals Australia Pty 
Ltd 
 
 
 
Medical Monitor / 
24-hour Emergency Contact 
 
 
 
 
  
 
 


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2. 
SYNOPSIS 
Name of Sponsor/Company: 
Caliway Biopharmaceuticals Australia Pty Ltd. 
Name of Investigational Product: 
CBL-514 
Name of Active Ingredient: 
 
Protocol Number: 
CBL-0202 
Title of Study: 
A 2-Stage Adaptive Design, Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL- 
514 Injection for Reducing Abdominal and Thigh Subcutaneous Fat 
Study Center(s): 
Multicenter 
Phase of Development: 
Phase 2 
Objectives: 
Primary Objectives: 
Stage 1: 
• 
Evaluate the safety and tolerability of injection lipolysis with CBL-514. 
Stage 2: 
• 
Assess the proportion of subjects who lose at least 150 mL of subcutaneous fat volume as 
measured by ultrasound compared with placebo 
Secondary Objectives: 
Stage 1: 
• 
Assess the efficacy of single course of CBL-514 at applicable dose levels in reducing 
subcutaneous fat over the treated area as measured by ultrasound compared with Baseline. 
Note: no efficacy endpoints/objectives will be assessed for Group 1 of Stage 1 study. 
Stage 2: 
• 
Assess the proportion of subjects who lose at least 200 mL of subcutaneous fat volume as 
measured by ultrasound compared with placebo 
 
Evaluate the number of treatments required to first occurrence of reducing at least 150 mL of 
subcutaneous fat volume over the treated area as measured by ultrasound in CBL-514 group 
• 
Assess the efficacy of up to 4 courses of CBL-514 in reducing subcutaneous fat volume over the 
treated area as measured by ultrasound compared with placebo 
 
Assess the efficacy of up to 4 courses of CBL-514 in reducing subcutaneous fat volume over the 
treated area as measured by ultrasound compared with Baseline 
• Evaluate safety following up to 4 courses of CBL-514 when compared with placebo. 
Methodology: 


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This is a 2-stage adaptive design, Phase 2 study to evaluate the efficacy, safety, and tolerability of 
CBL-514 injection for reducing subcutaneous fat. This Phase 2 study has an integrated design 
consisting of a single ascending dose (SAD) part in Stage 1 followed by a parallel-arm, placebo-
controlled design in Stage 2. A total of approximately 99 adult subjects (n = 24 [Stage 1]; n = 75 
[Stage 2]) with  
• 
thigh subcutaneous fat thickness of at least 1.00 cm (10.0 mm) and up to 4.00 cm (40.0 mm) 
measured by ultrasound at Screening and Day 1, for Group 1 in Stage 1, 
• 
abdominal subcutaneous fat thickness of at least 2.00 cm (20.0 mm) and up to 5.0 cm (50.0 mm) 
measured by ultrasound at Screening and Day 1 for Group 2-4 in Stage 1,  
• 
and abdominal skinfold thickness of at least 3.00 cm (30.0 mm) and up to 8.00 cm (80.0 mm) by 
pinch method (measured by calibrated caliper) at Screening for Stage 2, 
will be enrolled across the 2 stages of the study. 
Stage 1 (single dose, open label, dose escalation) 
The Stage 1 will include a total of 24 subjects enrolled in 4 sequential escalating CBL-514 dose 
groups: 320 mg, 480 mg, 640 mg and 800 mg. The groups will be open label. The 4 groups will each 
include 6 subjects. 
Subjects in Group 1 (320 mg) will receive CBL-514 injections on thighs, with total allocated dose of 
IP evenly divided into 2 thighs. Subjects from Group 2 to 4 (480 mg-800 mg) will receive CBL-514 
injections on abdomen with allocated dose of IP. 
Based upon Safety Review Committee (SRC) recommendation intermediate doses may be explored. 
Local effects of CBL-514 injection will be evaluated, and blood samples will be taken and analyzed 
to assess the safety of CBL-514. The dosing scheme is presented in the Table S1 below: 
Table S1: Dosing Scheme - Stage 1 
Group 
Treatment 
area 
CBL-
514 Dose 
Level 
(mg/cm2) 
Injection 
volume per 
injection 
in 4 cm2 
grid space 
Administration for one dose 
No. of 
Injection 
Total 
Injection 
Volume of 
CBL-514* 
(mL) 
Total CBL-514 (mg) 
1 
Thighs 
2.0 
1.6 mL 
40 / 20  
(total/ per 
thigh) 
64 / 32 
(total/ per 
thigh) 
320 
 
 
 
 
2 
Abdomen 
2.0 
1.6 mL 
60 
96 
480 
 
 
 
 
3 
Abdomen 
2.0 
1.6 mL 
80 
128 
640 
 
 
 
 
4 
Abdomen 
2.0 
1.6 mL 
100 
160 
800 
 
 


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*The concentration of CBL-514 is 5 mg/mL. 
Subjects will be screened for inclusion and exclusion criteria during a 28-day screening period 
(Day -28 to Day -1). At the Treatment visit (Day 1), eligible subjects will be sequentially assigned to 
receive one course of allocated CBL-514 dose. 
Subjects will visit the site on each of the study visits. Subjects will remain onsite for observation for 
at least 1 hour after the administration of the IP, or longer at the discretion of the Investigator, and 
until all planned assessments for the visit are completed. 
An Early Termination (ET) visit has been planned for subjects who are withdrawn from the study 
earlier than planned for assessment as soon as possible after early withdrawal, no later than 6 weeks 
from the last dose received. 
A subject diary will be provided to each subject, to record if there are any changes to the injection 
site/s or any discomforts from Day 1 until last clinic visit or when all injection site reactions (ISRs) 
have resolved or stabilized. Subjects will be instructed to bring the subject diary with them for all 
visits to the clinic. 
During Stage 1 of the study, the SRC will meet after all subjects in a dose group complete the Week 1 
visit. The SRC will review all reported adverse events (AEs), adverse event of special interests 
(AESIs), laboratory trends, and vital signs of all subjects from each dose group. Based upon review of 
available safety and tolerability data from each preceding dose group, the SRC will make a decision 
on progressing to the next dose group. 
The safety and tolerability data of CBL-514 from Stage 1 will be reviewed by the SRC before 
commencement of Stage 2. A top-level summary of safety data will be submitted to the relevant 
Institutional Review Board /Independent Ethics Committee (IRB/IEC) for review before proceeding 
to Stage 2 of the study. 
Stage 2 (multiple-dose, randomized, single-blind, parallel-group, placebo-controlled study) 
Stage 2 of the study will be initiated after IRB/EC review of a top-level summary of safety data from 
Stage 1 of the study. Stage 2 will be conducted as a single-blind, placebo-controlled study and will 
assess a single dose level of CBL-514. The dose of CBL-514 used in the Stage 2 will be set no higher 
than the highest safe dose from Stage 1. Each subject will receive up to 4 treatments of allocated 
CBL-514 (2 mg/cm²) or placebo administered on abdomen, once every 4 weeks. The minimum dose 
is 300 mg per treatment and the maximum dose is 600 mg per treatment. The dose adjustment will 
depend on the level of fat accumulation on subject’s abdomen at the discretion of the Investigator. 
 
 
 
 The minimum dose of 300 mg with 25 injections must be administered. It is at the 
discretion of the Investigator to perform dose adjustment for any dose over the minimum dose 
administration, which will depend on the level of fat accumulation on subject’s abdomen. The 
maximum dosing scheme is presented in Table S2 below. 
Table S2: Maximum Dosing Scheme - Stage 2 


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Group 
CBL-514 
Dose Level 
(mg/cm2) 
Injection 
volume per 
injection in 
6.0 cm2 grid 
space 
Administration for one dose 
No. of 
Injection 
Total 
Injection 
Volume of IP 
(mL) 
Total CBL-514 (mg) 
CBL-514 
2.0 
2.4 mL 
50 
120 
600 
 
 
Placebo 
- 
2.4 mL 
50 
120 
- 
- 
In Stage 2 of the study, considering drop-out rates (16% CBL-514 group vs 44% placebo group), 
approximately 75 subjects are planned to be enrolled and randomized 2:1 (50 subjects in the CBL-514 
group and 25 subjects in the placebo group) in order to have a total of 56 evaluable subjects. 
Randomization scheme is shown in Table S3: Randomization Scheme – Stage 2, below.  
Table S3: Randomization Scheme - Stage 2 
Planned Enrolled Subjects: 75 (2:1) 
Planned Evaluable Subjects 56 (3:1) 
CBL-514 Group 
- pre-drop out 
Placebo Group 
- pre drop out 
CBL-514 Group 
- post drop-out 
Placebo Group 
- post drop-out 
50 
25 
42 
14 
Subjects should have sufficient subcutaneous fat on the abdomen to receive injections on Day 1. This 
will be based on eligibility criteria as set out in inclusion criterion 3. Before administration, the 
Investigator should evaluate whether a subject is able to receive the minimum dose, 300 mg (25 
injections) as defined by Study Drug Administration Manual. 
 
 If a subject is not able to receive the minimum dose, the ongoing treatment 
and post-dose assessments will be cancelled, and the remaining treatment visits would not be required 
for that subject. For subjects that do not complete 4 treatments due to not enough residual fat, the 
subject will be requested to continue with follow-up visits (Visits 6 and 7). This arrangement would 
not be regarded as missing protocol required visits, or as discontinuation from the study. 
According to the schedule of assessments, the first follow up visit (Visit 6) should be performed 4 
weeks post the final treatment. If treatment is cancelled at Visits 3, 4 or 5 due to the insufficient 
abdominal fat, it is recommended that the first follow up visit is performed on the same day of the 
treatment cancellation. If not, then +7 days visit window should be utilized to schedule another day to 
complete the first follow up visit. 
If a subject cannot complete the 4 treatments and withdraws from the study for reasons other than 
dose adjustment, only the ET visit should be performed for final follow-up. 
Subjects will be screened for inclusion and exclusion criteria during a 28-day screening period 
(Day -28 to Day -1). At Visit 2 (Day 1), eligible subjects will be randomized (2:1) to receive either 
CBL-514 or placebo. As Stage 2 of the study is a randomized, single-blind, parallel-group, placebo-
controlled study, Subjects will be blinded to IP allocation in Stage 2. 
Subjects will visit the site on each of the study visits and will remain onsite for observation for 1 hour 
after the administration of IP, or shorter/ longer at the discretion of the Investigator and until all 
planned assessments for the visit are completed. 
An ET visit has been planned for subjects who are withdrawn from the study earlier than planned for 
assessment as soon as possible after early withdrawal, no later than 6 weeks from the last dose 
received. 


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A subject diary will be provided to each subject to record if there are any changes to the injection 
site/s or any discomforts in between visits. Subjects will be instructed to bring the subject diary with 
them for all visits to the clinic. 
SRC meeting 
Safety oversight will be provided by an SRC comprising the Investigator, the Sponsor’s 
Representative and Medical Monitor (MM). The SRC will be established prior to Screening. The 
details of SRC will be set out in an SRC Charter. 
During Stage 1 of the study, the SRC will meet after all subjects in a dose group complete the Week 1 
visit. The SRC will review all reported AEs, AESIs, laboratory trends, and vital signs of all subjects 
from each dose group. Based upon review of available safety and tolerability data from each 
preceding dose group, the SRC will make a decision on progressing to the next dose group. 
Before commencement of Stage 2, the SRC will review and evaluate safety data. A top-level 
summary of safety data will be submitted to the relevant IRB/IEC for review before proceeding to 
Stage 2 of the study. Planned dosing for Stage 2 will be based on a review of the safety data from 
Stage 1.  
In addition, occurrence of any of AESI or any AE that, based on the judgment of Investigator, raises a 
medical concern, should trigger a review by the SRC before proceeding with the dose escalation/s in 
Stage 1 or before proceeding with the next course of treatment in Stage 2. 
For SRC meetings, safety assessments will include the following: 
• 
Incidence of all AEs 
• 
AESI 
• 
Changes from Baseline in clinical laboratory test results 
• 
Changes from Baseline in vital signs. 
If at any time the study is terminated, a written statement fully documenting the reasons for 
termination will be provided to the relevant IRB/IEC. 
Definition of Adverse Event of Special Interest 
An AESI is any event which may be of medical concern specific to the IP. 
Occurrence of any of the below mentioned AESI should trigger a review by the SRC before 
proceeding with the dose escalation/s (Stage 1) or the next dose (Stage 2): 
1. 
Fat atrophy that extends > 2 cm from an injection point or is > 10% of the treated area 
or is associated with tenderness lasting > 24 hours. 
2. 
Pain limiting self-care activities of daily living (ADL) lasting more than 72 hours after 
active intervention (e.g. analgesic). 
3. 
Skin atrophy that extends beyond area of any erythema or induration or is > 10% of the 
treated area or is associated with tenderness lasting > 24 hours. 
4. 
Any skin hyper or hypopigmentation at the target area and/or the surrounding skin 
lasting for > 4 weeks. 
* The color change reflecting from the bruising color is not included. The color changes 
due to deposition or loss of pigment in epidermal tissue is considered as hyper or 
hypopigmentation. 
5. 
Any skin ulceration at the target area and/or the surrounding skin. 


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6. 
Any urticaria at the target area and/or the surrounding skin requiring oral treatment, 
lasting for > 72 hours. 
7. 
Telangiectasia at the target area and/or the surrounding skin lasting for > 7 days. 
8. 
Local numbness and/or paresthesia lasting for > 7 days. 
Above mentioned AESIs are to be reported to the Sponsor within 24 hours upon notification by 
Investigator and/or delegates. 
Study Stopping Criteria: 
Administration of IP in a dose group may be paused, and additional subjects will not receive further 
treatments, until a consultation has taken place between the Investigator, the MM, and the Sponsor 
representative under the following circumstances: 
• 
Any subject experiences an adverse event as Grade 3 (as defined in the National Cancer 
Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) 
for cardiovascular, renal or hepatic event considered to be at least possible related to IP, 
• 
Except for cardiovascular, renal, or hepatic events specified in Criterion #1, any 
participant experiences an AE as Grade 4 and considered to be at least possibly related to 
IP; 
• 
Any subject experiences a serious adverse event (SAE) that is considered to be at least 
possibly related to IP; 
• 
An AE or group of AEs that singularly or in aggregate suggests to the Investigator or 
Sponsor that the IP is poorly tolerated and further treatment per protocol (PP) may not be 
safe. 
If any of these criteria occur, consultation between the Sponsor representative, the Investigator, and 
the MM will take place as soon as possible to evaluate the event. Subjects should remain in the study 
and be followed until the adverse event resolves or stabilizes. 
Prohibitions and Restrictions in the Study 
Medication 
During the entire duration of the study (from Screening visit to end of study [EOS]/ET visit) use of 
following medications, treatment modalities, or diets are prohibited: 
a. Use of drugs for weight loss e.g. Orlistat (Xenical), Naltrexone HCl/Bupropion HCl 
(Contrave), etc., 
b. Use of anticoagulant/antiplatelet therapy or medications or dietary supplements which 
impede coagulation or platelet aggregation, 
c. Any cosmetic or interventional surgery procedures on area to be treated, 
d. Use of terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, 
Telfast, Xergic, Allegra, etc.), any medication that is known to strongly inhibit or induce 
CYP enzymes (please refer to Section 24.1), sensitive CYP substrates or drugs with 
narrow therapeutic index, in the opinion of the investigator, may affect the evaluation of 
the study product or place the participant at undue risk.  
If a subject requires the use of above mentioned therapeutic agents during the study for 
any reason, these therapeutic agents should not be used at least for 2 days prior to dosing 
and until 1 day post-dose. 
e. Use of other investigational drug or device within 4 weeks prior to Screening. 
f. Use of medication which is delivered via subcutaneous injection at the treatment area 
during the study period 


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Subjects should be advised not to take any prescription and over-the-counter (OTC) medications 
without consulting the Investigator. 
Contraception 
Highly effective contraceptive methods that can achieve a failure rate of less than 1% per year when 
used consistently and correctly should be used. The list below is based on the recommendation of the 
Clinical Trial Facilitation Group (CTFG 2014). 
• combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulation: 
o oral 
o intravaginal 
o transdermal 
• progestogen-only hormonal contraception associated with inhibition of ovulation1: 
o oral 
o injectable 
o implantable1 
 intrauterine device (IUD)1 
 intrauterine hormone-releasing system (IUS)1 
 bilateral tubal occlusion1 
 vasectomized partner 1,2 
• sexual abstinence3 
 condom used by male partner during sexual intercourse. 
Contraceptive requirements for male subjects with Women of childbearing potential (WOCBP) 
partner: A male subject should use condom during heterosexual intercourse and avoid sperm donation 
from the time of the first dose of study drug, throughout study participation until 12 weeks after the 
last study drug dose. For the WOCBP partner, contraception recommendations should also be 
considered. 
1 Contraception methods that in the context of this guidance are considered to have low user dependency. 
2 Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner 
of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the 
surgical success. 
3 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and 
the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation 
methods) and withdrawal (coitus interruptus) are not acceptable methods of contraception. This is applicable 
for both female and male subjects. 
Number of Subjects (Planned): 
Approximately 99 adult male or female subjects will be enrolled for the 2-stage study. 
A total of 24 subjects are planned to be enrolled in 4 sequential groups in Stage 1 of the study. 
Approximately 75 subjects are planned to be enrolled in Stage 2 of the study. Subjects in Stage 2 will 
be randomized 2:1 (i.e., CBL-514 group: 50 subjects; placebo group: 25 subjects) in order to have 56 
evaluable subjects for the 2 groups. The sample size for stage 2 of the study was calculated based on 
currently accepted standards for exploratory investigation design. 
Inclusion Criteria: 


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To be eligible for this study, a subject must meet all of the following inclusion criteria: 
1. Male or female, aged 18 years to 64 years old (at Screening), inclusive. 
2. Body mass index (BMI) > 18.5 and < 35 kg/m2 and body weight ≥ 50 kg at Screening and 
Day 1. 
3. Subject has sufficient subcutaneous fat thickness surrounding the center of localized area of 
treatment. 
a. For Group 1 (320 mg) in Stage 1, thigh subcutaneous fat thickness of at least 1.00 cm 
(10.0 mm) and up to 4.00 cm (40.0 mm) measured by ultrasound at Screening and Day 1.  
b. For Group 2-4 (480 mg-800 mg) in Stage 1, abdominal subcutaneous fat thickness of at 
least 2.00 cm (20.0 mm) and up to 5.00 cm (50.0 mm) measured by ultrasound at 
Screening and Day 1. 
c. For Stage 2, abdominal skinfold thickness of at least 3.00 cm (30.0 mm) and up to 8.00 
cm (80.0 mm) by pinch method (measured by calibrated caliper) at Screening. 
4. Subject has stable body weight (identified as ≦ 5% weight change per subject report) for at 
least 3 months before Screening and during the study. 
5. Subject who has maintained a stable lifestyle (e.g. exercise, eating patterns, and smoking 
habit) per subject report for at least 3 months before Screening and during the study. 
6. Voluntarily signs the Informed Consent Form (ICF) and, in the opinion of the Investigator or 
delegate, is physically and mentally capable of participating in the study, and willing to 
adhere to study procedures. 
Exclusion Criteria: 
A subject who meets any of the following exclusion criteria must be excluded from the study: 
1. Female subject of childbearing potential who is not willing to commit to an acceptable 
contraceptive regimen with her partner from the time of Screening and throughout study 
participation until 90 days after the last IP dose, or who is currently pregnant or lactating. 
Male subject who is not willing to commit to an acceptable contraceptive method. 
Note: Subjects who are not of childbearing potential are not required to use contraception. 
Females with no childbearing potential are defined as who have been surgically sterilized 
(hysterectomy or bilateral oophorectomy) or who are post-menopausal (defined as at least 50 
years with ≥ 12 months of amenorrhea with a follicle stimulating hormone (FSH) > 40 IU/L).  
2. Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet 
therapy or medications or dietary supplements, which impede coagulation or platelet 
aggregation. 
3. Subject has hemoglobin A1c (HbA1c) ≥ 9%, delayed wound healing, or any diabetic risks 
which, in the opinion of Investigator, is inappropriate to participate in the study. 
4. Subject has a clinically significant cardiovascular disease and abnormal findings in 
electrocardiogram (ECG). 
5. Subject with active or prior history of malignancies within 5 years before Screening or being 
worked-up for a possible malignancy. Except adequately treated basal cell carcinoma of skin 
and in situ squamous cell carcinoma of skin would be eligible as per Investigator’s discretion. 
6. Subject with a history of human immunodeficiency virus (HIV)-1, infection or subjects with 
active HIV infection at Screening with positive HIV antigen/antibody (Ag/Ab) combo test. 


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7. Subject with a history of Trypanophobia, the extreme fear of medical procedures involving 
injections or needles, or who experience vasovagal syncope and faint or pass out at the sight 
of blood or a needle. 
8. Subject has abnormal skin or local skin conditions at the treatment area, which in the opinion 
of Investigator, is inappropriate to participate in the study, including but not limited to any of 
the following: 
a. Skin manifestations of a systemic disease, 
b. Any abnormality of the skin or soft tissues of the area to be treated, 
c. Grade III cellulite (Nürnberger and Muller scale, Nürnberger F, 1978) at the area to be 
treated, 
d. Skin folding or fat folding on abdomen 
e. Sensory loss or dysesthesia in the area to be treated, 
f. Evidence of any cause of enlargement in the area to be treated other than localized 
abdominal or thigh subcutaneous fat, 
g. Tattoos on the area to be treated. 
9. Subject who has undergone the following procedures: 
a. Previous surgery which caused scar tissues on the anticipated treatment area before 
Screening or during the study, except laparoscopic surgery and surgery which cause very 
small scar tissues would be eligible as per Investigator’s discretion, 
b. Liposuction to the region to be treated before Screening or during the study, 
c. Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, low level laser therapy (LLLT), 
lipolysis injection to the region to be treated within 12 months before Screening or during 
the study. 
d. Using medication which is delivered via subcutaneous injection at the treatment area 
during the study period. 
10. Subject is on prescription or OTC weight reduction medication or weight reduction programs 
within 3 months before Screening or during the study. 
11. Subject is undergoing chronic steroid or immunosuppressive therapy, with the exception of 
oral steroid inhalation indicated for asthma management or topical steroid application for skin 
conditions that are not directly applied or indirectly affect the treatment area. 
12. Requiring continual use of the following therapeutic agents during the study: terfenadine 
(Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, Allegra, 
etc.), any medication that is known to strongly inhibit or induce CYP enzymes (please refer to 
Section 24.1), sensitive CYP substrates or drugs with narrow therapeutic index, in the opinion 
of the investigator, may affect the evaluation of the study product or place the participant at 
undue risk. 
If a subject needs to use the above mentioned therapeutic agents during the study for any 
reason, these therapeutic agents should not be used at least for 2 days prior to dosing and until 
1 day post-dose. 
13. Unable to receive local anesthesia (e.g., history of hypersensitivity to lidocaine). 
14. Subjects with known allergies or sensitivities to the IP or its components. 
15. Subjects with liver cirrhosis, with inadequate liver function at Screening defined as aspartate 
aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALKP), total 


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bilirubin (TBIL), or gamma-glutamyl transferase (GGT) > 3.0 × upper limit of normal 
(ULN), or with any hepatic medical condition that would interfere with assessment of safety 
or efficacy or compromise the subject's ability to undergo study procedures or provide 
informed consent. 
16. Subjects with any renal impairment, defined as abnormal serum creatinine, and urea 
> 1.5 × ULN or estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2. Subjects 
who are currently on dialysis should be excluded. 
Subjects with an eGFR ≥ 60 and < 90 mL/min/1.73 m2 at Screening should be evaluated by 
the Investigator to exclude pre-existing renal disease or associated dysfunction. If mild 
decrease in eGFR is assessed by the Investigator as not clinically significant or not related to 
dysfunction, the subjects may be eligible upon the Investigator’s assessment. 
17. Use of other investigational drug or device within 12 weeks prior to Screening. 
Withdrawal criteria 
A subject must be removed from the study at any time, if any of the following criteria is met: 
Stage 1 
1. Subject withdraws consent. 
2. Between Screening and Day 1, subjects whose overall body weight change of ≥ 3kg. 
3. Subject has body weight change ≥ 5 % based on Day 1 body weight. 
4. Any other clinical AE, medical condition, or situation that in the opinion of the Investigator 
would not be in the best interest of the subject. 
5. Subject who cannot complete follow-up visits within 6 weeks post treatment visit. 
Stage 2 
1. Subject withdraws consent. 
2. Subject has body weight change ≥ 3 kg compared to Day 1 body weight during the whole 
study period. 
3. Subject has body weight change ≥ 3 kg during the follow-up period compared to the body 
weight from the last treatment visit. 
4. Any other clinical AE, medical condition, or situation that in the opinion of the Investigator 
would not be in the best interest of the subject. 
5. Subjects has a treatment interval > 6 weeks in length between any of the dosing courses. 
6. Subject cannot complete at least the first follow-up visit (Visit 6 / end of treatment [EOT]) 
within 6 weeks post final treatment visit, or cannot complete the second follow-up visit (Visit 
7 / EOS) within 10 weeks post final treatment visit. 
7. Subject has efficacy related major protocol violation at Day 1 (baseline) 
Investigational Product, Dosage and Mode of Administration: 
Table S4: CBL-514 Product Details 
Name  
CBL-514  
Dosage Form  
Solution for Injection  


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Dose Concentration Per Vial  
5 mg/mL  
Size of Vial  
20 mL/vial  
Active Ingredient  
 
  
Mode of Administration  
Subcutaneous injection  
Storage  
Store at 4°C (39°F), excursions are permitted between 2°C 
and 8°C  
Duration of Treatment: 
The Screening period is 28 days (Day -28 to Day -1) for both stages of the study. 
Stage 1 
Each subject will participate in Stage 1 of the study for approximately 4 weeks, including a Baseline 
visit on Day 1, and 3 follow-up visits at Week 1, Week 2, Week 4, respectively. 
Stage 2 
Each subject will participate in Stage 2 of the study for approximately 20 weeks, including a Baseline 
visit on Visit 2 (Day 1), 1 visit every 4 weeks during the treatment period (Visits 3, 4, and 5), and 
2 follow-up visits at Visit 6 (Visit 5+ 4 weeks) and 7 (Visit 5+ 8 weeks). 
Duration of study participation is defined as the period between the day the subject provides written 
consent and until all study required examinations have been completed. 
Reference Therapy, Dosage and Mode of Administration: 
Placebo 
The placebo to be used in the study will be commercially available (isotonic) Sodium Chloride for 
injection (0.9% NaCl). Equivalent volume of Sodium Chloride injection will be administered by 
subcutaneous injection. 
Criteria for Evaluation: 
Primary Endpoints 
Stage 1 
The primary endpoints of Stage 1 of the study are: 
• 
Safety and tolerability following single dose of CBL-514 as assessed by recording of 
treatment emergent adverse events (TEAEs), laboratory assessments, vital signs, ECGs, 
physical examinations, and injection site assessment. 
Stage 2 
The primary endpoints of Stage 2 of the study are: 
• 
The proportion of subjects who lose at least 150 mL of subcutaneous fat as measured by 
ultrasound from Baseline to follow-up visits compared with placebo.  
[Time frame: Visit 2 (Baseline), Visit 6 and Visit 7] 
Secondary Endpoints 
Stage 1 
The secondary endpoints of Stage 1 of the study are: 
• 
Reduction of subcutaneous fat thickness as measured by ultrasound compared with Baseline. 
[Time frame: Day 1 and Week 4] 
 
Reduction of subcutaneous fat volume over the treated area as measured by ultrasound 


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compared with Baseline.  
[Time frame: Day 1 and Week 4] 
*Note: no efficacy endpoints/objectives will be assessed for Group 1 of Stage 1 study. 
Stage 2 
The secondary endpoints of Stage 2 of the study are: 
• 
The proportion of subjects who lose at least 200 mL of subcutaneous fat as measured by 
ultrasound from Baseline to follow-up visits compared with placebo.  
[Time frame: Visit 2 (Baseline), Visit 6 and Visit 7] 
• 
Number of treatments required to first occurrence of reducing at least 150 mL of 
subcutaneous fat volume over the treated area as measured by ultrasound in CBL-514 group 
[Time frame: from Visit 2 (Baseline) to Visit 7] 
• 
Reduction of subcutaneous fat volume over the treated area as measured by ultrasound from 
Baseline to follow-up visits compared with placebo.  
[Time frame: Visit 2 (Baseline), Visit 6 and Visit 7] 
• 
Reduction of subcutaneous fat volume over the treated area of the CBL-514 group as 
measured by ultrasound compared with individual Baseline.  
[Time frame: Visit 2 (Baseline), Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7] 
• 
Safety as assessed by recording of TEAEs, laboratory assessments, vital signs, ECGs, 
physical examinations, and ISRs compared with placebo. 
Statistical Methods 
Complete details of the statistical analyses and methods, including data conventions, will be provided 
in the statistical analysis plan (SAP). The SAP will be finalized before the database is locked. 
Descriptive statistics will be used to summarize the safety and efficacy data. No formal hypothesis 
testing is planned, and dose comparisons will be exploratory in nature. 
No adjustments will be made for missing or incomplete data, except for missing efficacy data which 
may be imputed using multiple imputation. 
The Baseline value is defined as the last available result collected/derived prior to the first treatment 
administration. The change from Baseline value is defined as the difference between the result at the 
post-Baseline time point and the Baseline value. 
Descriptive statistics will consist of the number of observations (n), mean, standard deviation (SD), 
minimum, median, and maximum for continuous data. Where applicable, 95% confidence intervals 
(CIs) for the mean may be presented. 
Categorical data will be summarized using counts and percentages. Unless specifically stated 
otherwise, the denominator for all percentage calculations will be the number of subjects in the 
treatment group for the specific analysis set. Where applicable, 95% CIs (Clopper-Pearson) may be 
presented. 
All collected and derived data will be listed. 
Analysis Populations 
Intent-to-treat population: 
The intent-to-treat (ITT) population will include all enrolled or randomized subjects who received at 
least one course of IP treatment 
Safety Population: 


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All subjects who receive at least one confirmed dose of IP will be included in the safety population. 
Subjects will be analyzed according to the treatment they actually receive. The safety population will 
be used for summaries and listings of safety, tolerability, and drug exposure data. 
Per protocol population:  
Stage 1 
• 
A subset of ITT 
• 
Subjects without any efficacy related major protocol violations 
• 
Subjects who complete the proposed dosing schedule of study drug and complete all follow-up 
visits after treatment 
• 
Subjects whose body weight remain stable throughout the study, identified as having body 
weight change < 3% based on Day 1 body weight 
However, a subject who was discontinued due to an AE, or died before the required exposure could 
be met, will still be included in this population. 
Stage 2 
• 
A subset of ITT 
• 
Subjects without any efficacy related major protocol violations 
• 
Subjects who complete all proposed dosing schedules of study drug and complete 2 follow-up 
visits after treatment (including the subject who has dose adjustment judged by the Investigator) 
• 
Subjects have all visits of IP administration within 6 weeks. 
• 
Subjects whose body weight remain stable throughout the study, identified as having body 
weight change < 2.5 kg compared to last visit and change of body weight < 3 kg compared to 
Day 1 body weight. 
• 
Subjects whose Visit 6 is performed 3 to 5 weeks post final treatment 
• 
Subjects whose Visit 7 is performed 7 to 9 weeks post final treatment 
 
However, a subject who was discontinued due to an AE, or died before the required exposure could 
be met, will still be included in this population. 
Safety and Tolerability Assessment 
Safety and Tolerability assessment is the primary objective of Stage 1 of the study and secondary 
objective of Stage 2 of the study. 
All safety assessments, including AEs, laboratory evaluations, vital signs, ECGs, physical 
examination, ISR and other safety assessments, will be analyzed using the Safety population. 
• 
AEs will be coded using the most current version of the Medical Dictionary for Regulatory 
Activities (MedDRA®) available at the start of the study. A by subject AE data listing, 
including verbatim term, Preferred Term (PT), System Organ Class (SOC), treatment, severity, 
and relationship to IP, will be provided. The number of subjects experiencing TEAEs and 
number of individual TEAEs will be summarized among treatment groups (or sequences), by 
SOC and PT. TEAEs will also be summarized among treatment groups (or sequences), by 
severity and by relationship to IP. 
• 
Clinical laboratory tests and vital signs of observed values and changes from Baseline will be 
summarized using descriptive statistics. Physical examination findings, injection site 
assessments, and ECGs will also be summarized descriptively. 
Safety data from Stage 1 will be reviewed during the SRC meeting before commencement of Stage 2 
of the study. A top-level summary of safety data will be submitted to the relevant IEC/IRB for review 


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before proceeding to Stage 2 of the study. 
Efficacy Assessments 
Efficacy will be analyzed in both Stage 1 and Stage 2 of the study. 
Stage 1 
Efficacy endpoints to be analyzed in Stage 1 are: 
• 
Reduction of subcutaneous fat thickness as measured by ultrasound compared with Baseline 
• 
Reduction of subcutaneous fat volume over the treated area as measured by ultrasound 
compared with Baseline. 
*Note: no efficacy assessments will be done for Group 1 of Stage 1 study. 
The reduction of subcutaneous fat thickness and subcutaneous fat volume over the treated area will be 
summarized with descriptive statistics. An estimate of the 95% CI for the mean reduction in 
subcutaneous fat thickness and corresponding p-value will also be provided. 
The analysis set for the primary efficacy analysis is the ITT population. The primary analysis will be 
repeated using the PP population, as relevant. Exploratory analyses may be performed to assess 
differences between the dose levels. 
Full details of all efficacy analyses will be provided in the SAP. 
Stage 2 
Primary efficacy endpoints to be analyzed in Stage 2 are: 
• 
The proportion of subjects who lose at least 150 mL of subcutaneous fat as measured by 
ultrasound from Baseline to follow-up visits compared with placebo. 
Secondary efficacy endpoints to be analyzed in Stage 2 are: 
• 
The proportion of subjects who lose at least 200 mL of subcutaneous fat as measured by 
ultrasound from Baseline to follow-up visits compared with placebo. 
• 
Number of treatments required to first occurrence of reducing at least 150 mL of subcutaneous 
fat volume over the treated area as measured by ultrasound in CBL-514 group 
• 
Reduction of subcutaneous fat volume over the treated area as measured by ultrasound 
compared with placebo 
• 
Reduction of subcutaneous fat volume over the treated area as measured by ultrasound 
compared with Baseline 
For the primary endpoint, the proportion of subjects who lose at least 150 mL of subcutaneous fat will 
be summarized for CBL-514 and placebo, respectively, along with their 95% confidence intervals. 
The analysis set for the primary efficacy endpoint is the ITT population. The primary analysis will be 
repeated using the PP population, as relevant. Exploratory analyses may be performed to assess 
differences between treatments. 
All analyses will be performed without adjustment for multiple endpoints. 
Full details of all efficacy analyses will be provided in the SAP. 


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TABLE OF CONTENTS 
1. 
TITLE PAGE ..............................................................................................................1 
INVESTIGATOR’S AGREEMENT ............................................................................................4 
PROCEDURES IN CASE OF EMERGENCY ...........................................................................5 
2. 
SYNOPSIS ...................................................................................................................6 
3. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES...................................................................................................................20 
4. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS .......................28 
5. 
FACILITIES AND PERSONNEL ..........................................................................31 
6. 
BACKGROUND AND INTRODUCTION ............................................................32 
6.1. 
Introduction .................................................................................................................32 
6.1.1. 
Unmet Medical Need ..................................................................................................32 
6.1.2. 
Overview of CBL-514 ................................................................................................33 
6.2. 
Summary of Nonclinical and Clinical Studies............................................................33 
6.2.1. 
Nonclinical Studies .....................................................................................................33 
6.2.2. 
Clinical Studies ...........................................................................................................34 
6.3. 
Rationale for the Study ...............................................................................................35 
6.4. 
Dosage and Treatment Periods ...................................................................................35 
6.4.1. 
Rationale for Dose Selection ......................................................................................35 
6.5. 
Subject Population ......................................................................................................36 
6.6. 
Ethical Principles ........................................................................................................37 
7. 
TRIAL OBJECTIVES AND PURPOSE ................................................................38 
7.1. 
Objectives ...................................................................................................................38 
7.1.1. 
Primary Objectives .....................................................................................................38 
7.1.1.1. 
Stage 1 ........................................................................................................................38 
7.1.1.2. 
Stage 2 ........................................................................................................................38 
7.1.2. 
Secondary Objectives .................................................................................................38 
7.1.2.1. 
Stage 1 ........................................................................................................................38 
7.1.2.2. 
Stage 2 ........................................................................................................................38 
7.2. 
Endpoints ....................................................................................................................39 
7.2.1. 
Primary Endpoints ......................................................................................................39 


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7.2.1.1. 
Stage 1 ........................................................................................................................39 
7.2.1.2. 
Stage 2 ........................................................................................................................39 
7.2.2. 
Secondary Endpoints ..................................................................................................39 
7.2.2.1. 
Stage 1 ........................................................................................................................39 
7.2.2.2. 
Stage 2 ........................................................................................................................39 
8. 
INVESTIGATIONAL PLAN ..................................................................................41 
8.1. 
Overall Study Design ..................................................................................................41 
8.2. 
Number of Subjects ....................................................................................................43 
8.3. 
Dose Adjustment and Safety Oversight ......................................................................43 
8.4. 
Stopping Criteria .........................................................................................................44 
8.5. 
Criteria for Study Termination ...................................................................................44 
9. 
SELECTION AND WITHDRAWAL OF SUBJECTS .........................................55 
9.1. 
Subject Inclusion Criteria ...........................................................................................55 
9.2. 
Subject Exclusion Criteria ..........................................................................................55 
9.3. 
Prohibitions and Restrictions in the Study ..................................................................57 
9.3.1. 
Medication ..................................................................................................................57 
9.3.2. 
Contraception ..............................................................................................................58 
9.4. 
Screen Failures ............................................................................................................59 
9.5. 
Subject Replacement ..................................................................................................59 
9.6. 
Subject Withdrawal Criteria .......................................................................................59 
10. 
INVESTIGATIONAL PRODUCTS .......................................................................61 
10.1. 
CBL-514 .....................................................................................................................61 
10.2. 
Reference/Placebo ......................................................................................................61 
10.3. 
Dosage and Treatment Periods ...................................................................................61 
10.3.1. 
Stage 1 ........................................................................................................................61 
10.3.2. 
Stage 2 ........................................................................................................................62 
10.4. 
Method of Assigning Participants to Treatment .........................................................63 
10.4.1. 
Randomization ............................................................................................................63 
10.5. 
Concomitant Medications ...........................................................................................63 
10.6. 
Treatment Compliance ................................................................................................64 
10.7. 
Blinding ......................................................................................................................64 
11. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................65 
11.1. 
Study Drug ..................................................................................................................65 


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11.2. 
Study Drug Packaging and Labelling .........................................................................65 
11.3. 
Study Drug Storage .....................................................................................................65 
11.4. 
Study Drug Preparation ..............................................................................................65 
11.5. 
Administration ............................................................................................................65 
11.6. 
Study Drug Accountability .........................................................................................66 
11.7. 
Study Drug Handling and Disposal ............................................................................66 
12. 
STUDY SCHEDULE ................................................................................................67 
12.1. 
Stage 1 ........................................................................................................................67 
12.1.1. 
Visit 1: Screening (Day -28 to Day -1) .......................................................................67 
12.1.2. 
Visit 2: Treatment/Baseline (Day 1) ...........................................................................68 
12.1.2.1. 
Before Dosing .............................................................................................................68 
12.1.2.2. 
Dosing .........................................................................................................................69 
12.1.2.3. 
After Dosing ...............................................................................................................69 
12.1.3. 
Visits 3 and 4: Follow-up Period (Week 1/Day 8 [±4 Days] and Week 2/Day 
15 [± 4 Days]) .............................................................................................................69 
12.1.4. 
Visit 5: End of Study Visit (Week 4/Day 29 [±4 Days]) ............................................70 
12.1.5. 
Early Termination (if applicable) ...............................................................................71 
12.2. 
Stage 2 ........................................................................................................................72 
12.2.1. 
Visit 1: Screening (Day -28 to Day -1) .......................................................................72 
12.2.2. 
Visit 2: Treatment/Baseline (Day 1) ...........................................................................72 
12.2.2.1. 
Before Dosing .............................................................................................................72 
12.2.2.2. 
Dosing .........................................................................................................................74 
12.2.2.3. 
After Dosing ...............................................................................................................74 
12.2.3. 
Visits 3, 4 and 5 (EOT) Treatment Period (Visit 2+ 4 weeks [+7 Days], Visit 
3 + 4 weeks [+7 Days], and Visit 4+ 4 weeks [+7 Days]) ..........................................74 
12.2.3.1. 
Before Dosing .............................................................................................................74 
12.2.3.2. 
Dosing .........................................................................................................................75 
12.2.3.3. 
After Dosing ...............................................................................................................75 
12.2.4. 
Visits 6: Follow-up Period (Visit 5+ 4 weeks [±7 Days]) ..........................................76 
12.2.5. 
Visit 7: End of Study Visit (Visit 5+ 8 weeks [±7 Days]) ..........................................77 
12.2.6. 
Early Termination (if applicable) ...............................................................................77 
13. 
EFFICACY ASSESSMENTS ..................................................................................79 
13.1. 
Abdominal or Thigh Subcutaneous Fat Thickness .....................................................79 


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13.2. 
Abdominal or Thigh Subcutaneous Fat Volume ........................................................79 
13.3. 
The proportion of subjects with a loss of at least 15% of baseline abdominal 
fat volume ...................................................................................................................79 
13.4. 
9-point CBL-514 Satisfaction Questionnaire Score ...................................................79 
14. 
ASSESSMENT OF SAFETY...................................................................................80 
14.1. 
Safety Parameters .......................................................................................................80 
14.1.1. 
Demographic/Medical History ...................................................................................80 
14.1.2. 
Vital Signs ..................................................................................................................80 
14.1.3. 
Anthropometric Parameters ........................................................................................80 
14.1.4. 
Injection Site Reactions ..............................................................................................80 
14.1.5. 
Physical Examination .................................................................................................81 
14.1.6. 
Electrocardiogram .......................................................................................................81 
14.1.7. 
Laboratory Assessments .............................................................................................81 
14.1.7.1. 
Hematology .................................................................................................................81 
14.1.7.2. 
Biochemistry ...............................................................................................................81 
14.1.7.3. 
Coagulation .................................................................................................................82 
14.1.7.4. 
Urinalysis ....................................................................................................................82 
14.1.7.5. 
Viral Serology .............................................................................................................82 
14.1.7.6. 
Pregnancy Testing ......................................................................................................83 
14.1.7.7. 
Follicle Stimulating Hormone Testing .......................................................................83 
14.1.7.8. 
Photographs ................................................................................................................83 
14.2. 
Adverse and Serious Adverse Events .........................................................................84 
14.2.1. 
Definition of Adverse Events .....................................................................................84 
14.2.1.1. 
Severity of an Adverse Event .....................................................................................85 
14.2.1.2. 
Causal Relationship of an Adverse Event ..................................................................86 
14.2.1.3. 
Action Taken with Investigational Products ...............................................................86 
14.2.1.4. 
Outcome ......................................................................................................................87 
14.2.2. 
Definition of Adverse Event of Special Interest .........................................................87 
14.2.3. 
Definition of Serious Adverse Event ..........................................................................87 
14.2.4. 
Notification of a Serious Adverse Event ....................................................................88 
14.2.5. 
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events and Serious Adverse Events .............................................................89 
14.2.6. 
Recording Adverse Events .........................................................................................89 


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14.3. 
Follow-up of Adverse Events and Serious Adverse Events .......................................90 
14.4. 
Pregnancy ...................................................................................................................90 
14.5. 
Dose Limiting Toxicity ...............................................................................................91 
15. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ....................................91 
15.1. 
Study Monitoring ........................................................................................................91 
15.2. 
Data Management .......................................................................................................92 
15.3. 
Audits and Inspections ................................................................................................92 
16. 
STATISTICS .............................................................................................................93 
16.1. 
Analysis Populations ..................................................................................................93 
16.1.1. 
Intent-to-treat Population ............................................................................................93 
16.1.2. 
Safety Population ........................................................................................................93 
16.1.3. 
Per Protocol Population ..............................................................................................94 
16.2. 
Safety and Tolerability ...............................................................................................94 
16.2.1. 
Adverse Event .............................................................................................................94 
16.2.2. 
Laboratory Evaluations ...............................................................................................95 
16.2.3. 
Vital Signs ..................................................................................................................95 
16.2.4. 
12-Lead Electrocardiograms .......................................................................................95 
16.2.5. 
Other Safety Assessments ...........................................................................................95 
16.3. 
Efficacy .......................................................................................................................95 
16.3.1. 
Stage 1 ........................................................................................................................95 
16.3.2. 
Stage 2 ........................................................................................................................96 
17. 
ETHICS .....................................................................................................................97 
17.1. 
Ethics Review .............................................................................................................97 
17.2. 
Ethical Conduct of the Study ......................................................................................97 
17.3. 
Written Informed Consent ..........................................................................................97 
17.4. 
Data Protection ...........................................................................................................98 
18. 
DATA HANDLING AND RECORDKEEPING....................................................98 
18.1. 
Inspection of Records .................................................................................................98 
18.2. 
Retention of Records ..................................................................................................98 
18.3. 
Liability/Indemnity/Insurance ....................................................................................98 
19. 
PUBLICATION POLICY ........................................................................................99 
19.1. 
Publication of Results .................................................................................................99 
19.2. 
Disclosure and Confidentiality ...................................................................................99 


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20. 
QUALITY CONTROL AND QUALITY ASSURANCE ....................................100 
20.1. 
Compliance with Good Clinical Practice .................................................................100 
20.2. 
Archiving and Regulatory Inspection .......................................................................100 
21. 
CLINICAL STUDY REPORT ..............................................................................100 
22. 
SPONSOR AND INVESTIGATOR OBLIGATIONS ........................................101 
22.1. 
Protocol Amendments ..............................................................................................101 
22.2. 
Protocol Deviations ..................................................................................................101 
23. 
LIST OF REFERENCES .......................................................................................102 
24. 
APPENDIX ..............................................................................................................103 
24.1. 
Appendix I: Reference List of Prohibited Substances (CYP inhibitors and 
inducers only) ...........................................................................................................103 
 


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LIST OF TABLES 
Table 1: 
Emergency Contact Information ...................................................................................5 
Table 2: 
Abbreviations and Specialist Terms ...........................................................................28 
Table 3: 
Facilities and Personnel ..............................................................................................31 
Table 4: 
Schedule of Assessments - Stage 1 .............................................................................48 
Table 5: 
Schedule of Assessments – Stage 2 ............................................................................51 
Table 6: 
CBL-514 Product Details ...........................................................................................61 
Table 7 
Dosing Scheme-Stage 1 ..............................................................................................61 
Table 8 
Maximum Dosing Scheme-Stage 2 ............................................................................62 
Table 9: 
CTCAE Severity Grade Description ..........................................................................85 
Table 10: Criteria for Determination of Adverse Event Relationship to IP ...............................86 
 


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LIST OF FIGURES 
Figure 1: 
Study Design ...............................................................................................................46 
Figure 2 
VAS- Pain Intensity Scale ..........................................................................................85 
 


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4. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
The following abbreviations and specialist terms are used in this study protocol. 
Table 2: 
Abbreviations and Specialist Terms 
Abbreviation or Specialist Term 
Explanation 
ADL 
Activities of daily living 
AE 
Adverse event 
AESI 
Adverse event of special interest 
Ag/Ab 
Antigen/antibody 
ALT 
Alanine aminotransferase 
ALKP/ALP 
Alkaline phosphatase 
ASAPS 
American Society for Aesthetic Plastic Surgery 
AST 
Aspartate aminotransferase 
ATC 
Anatomical therapeutic chemical 
β-hCG 
Beta human chorionic gonadotropin 
BMI 
Body mass index 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CSR 
Clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
ECG 
Electrocardiogram 
eGFR 
Estimated glomerular filtration rate 
EOS 
End of study 
EOT 
End of treatment 
ET 
Early termination 
FDA 
Food and Drug Administration 
FBS 
Fasting blood sugar 
FSH 
Follicle stimulating hormone 
GCP 
Good Clinical Practice 
GGT 
Gamma-glutamyl transferase 
GLP 
Good Laboratory Practice 
GMP 
Good Manufacturing Practice 
Hb 
Hemoglobin 
HbA1c 
Hemoglobin A1c 


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Abbreviation or Specialist Term 
Explanation 
HBV 
Hepatitis B Virus 
HCV 
Hepatitis C Virus 
HDL 
High-density lipoprotein 
HED 
Human equivalent dose 
HIFU 
High intensity focused ultrasound 
HIV 
Human immunodeficiency virus 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference for Harmonisation 
IEC 
Independent Ethics Committee 
IP 
Investigational product 
IRB 
Institutional Review Board 
ISR 
Injection site reaction 
ITT 
Intent-to-treat 
IUD 
Intrauterine device 
LDL 
Low-density lipoprotein 
LLLT 
Low level laser therapy 
MedDRA® 
Medical Dictionary for Regulatory Activities 
MM 
Medical monitor 
NOAEL 
No-observed-adverse-effect-level 
OTC 
Over-the-counter 
PP 
Per protocol 
PT 
Preferred term 
RBC 
Red blood cell 
SAD 
Single ascending dose 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SOC 
System organ class 
SOP 
Standard operating procedure 
SRC 
Safety Review Committee 
TBIL 
Total bilirubin 


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Abbreviation or Specialist Term 
Explanation 
TEAE 
Treatment emergent adverse event 
TGA 
Therapeutic Goods Administration 
ULN 
Upper limit of normal 
US 
United States 
VAS 
Visual Analogue Scale 
WBC 
White blood cell 
WHO 
World Health Organization 
WOCBP 
Woman of childbearing potential 
 
 


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5. 
FACILITIES AND PERSONNEL 
 
Table 3: 
Facilities and Personnel 
Sponsor 
Caliway Biopharmaceuticals Australia Pty Ltd 
 
 
Local Australian Sponsor 
Caliway Biopharmaceuticals Australia Pty Ltd 
 
 
 
Local MM 
 
 
 
 


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6. 
BACKGROUND AND INTRODUCTION 
6.1. 
Introduction 
6.1.1. 
Unmet Medical Need 
The focus on body aesthetics and appearance continues to influence the treatment-seeking 
behavior of several people in the modern society. The most popular body contouring approaches 
used to improve the cosmesis of subcutaneous fat deposits are surgical and include liposuction, 
abdominoplasty, and thigh lifts, among other procedures. This increasing demand has led to the 
rapid growth and development of noninvasive, non-surgical treatment techniques. Although 
surgical techniques can result in the most pronounced outcomes in respect to improved body 
contouring results, they are also associated with inherent risk and complications such as pain, 
swelling, prolonged recovery, scarring, hematoma or infection, which make noninvasive 
procedures increasingly popular (Adatto MA, 2014; Kennedy J, 2015). 
The risks, financial costs and lengthy downtime associated with surgical procedures for fat 
reduction have led to the development of a number of noninvasive techniques (Kennedy J, 2015). 
In the recent years, noninvasive body contouring techniques have become one of the most 
widespread procedures and are growing fast in areas of esthetic medicine (Nestor MS, 2013). 
Noninvasive treatment approaches are painless, safe, and require little to no downtime (Adatto 
MA, 2014). 
According to reported data by the American Society for Aesthetic Plastic Surgery (ASAPS) in 
2013, the significant risk of invasive body contouring procedures has led to 521% growth of 
noninvasive techniques since 1997 (Rotunda AM, 2006). In addition, it has been estimated that 
noninvasive body contouring procedures are growing by 21% annually (Atiyeh BS, 2008). Even 
for shortening postoperative recovery, decreasing bruising and more skin tightening, surgical 
lipectomy techniques are combined with noninvasive methods (Atiyeh BS, 2008). 
Commonly used treatment options for abdominal and thigh subcutaneous fat have been limited 
to invasive surgical or non-surgical procedures. Lipoplasty (including thigh liposuction) was the 
second most popular procedure performed by ASAPS members in 2019, with 270,670 
procedures performed. Thigh lifts were performed at a rate of 9,815 in 2019 by ASAPS members 
(ASAPS, 2019). Unfortunately, surgical liposuction under general anesthesia carries significant 
potential risk and complications to a person seeking an aesthetic improvement; 2 independent 
surveys of board‑certified aesthetic plastic surgeons in the United States (US) determined the 
mortality rate to be approximately 20 deaths per 100,000 procedures (Grazer FM, 2000). As for 
non-surgical procedures, there are now numerous options for fat reduction which utilize medical 
devices to deliver certain frequency of energy or cold temperature through the skin to ablate 
subcutaneous fat cells in the anterior abdomen, such as radiofrequency (RF), high intensity 
focused ultrasound (HIFU), Cryolipolysis or LLLT (Friedmann DP, 2015). In many cases (e.g., 
cryolipolysis, HIFU), these non-surgical procedures also cause inflammation which is related to 
the mechanism of removing the ablated fat cells from the treated area (Jalian HR, 2012). This 
inflammatory process may result in pain, swelling and redness along with the increased recovery 
time for the process to complete and time to view aesthetic benefit. In addition, the cost of these 
devices as well as the disposables required must be taken into consideration for each treatment. 


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There is another non-surgical treatment for reducing subcutaneous fat which is known as 
mesotherapy or lipodissolve, a minimally invasive procedure. Mesotherapy involves a series of 
injections of medications that are purported to melt away localized fat deposits. Combinations of 
drugs such as phosphatidylcholine and deoxycholate (commonly called PC and DC, 
respectively), DC alone or combinations including other drugs or products such as vitamins, 
minerals, and herbal extracts may be used (Rotunda AM, 2006, Atiyeh BS, 2008). However, 
warning letters were issued by the Food and Drug Administration (FDA) to medical spas 
offering mesotherapy for unfounded claims of efficacy (Atiyeh BS, 2008, Duncan D, 2011). 
There were also numerous reports of significant AEs (e.g., skin necrosis, infections, etc.) due to 
unregulated mesotherapy (Atiyeh BS, 2008, Duncan D, 2011). This creates an unmet medical 
need to develop an injectable alternative with promising efficacy and an acceptable safety profile 
to fulfill the need of reducing abdominal and thigh subcutaneous fat. 
6.1.2. 
Overview of CBL-514 
CBL-514 Injection (CBL-514), is a new injection for lipolysis product developed by Caliway 
Biopharmaceuticals Co., Ltd. The product is supplied with 20 mL in a glass vial with a stopper. 
Each mL of CBL-514 contains 5 mg the drug substance, the CBL-514 Powder, with 
 
 serving 
as the active pharmaceutical ingredients. CBL-514 is compatible to use with needle and syringe 
for subcutaneous injection. 
CBL-514 has shown promising efficacy and safety profiles in prior research in in vitro and 
animal models for the proposed indication in promoting adipose cell apoptosis. 
6.2. 
Summary of Nonclinical and Clinical Studies 
6.2.1. 
Nonclinical Studies 
CBL-514 has undergone an extensive nonclinical safety and efficacy evaluation. These 
nonclinical studies conducted for CBL-514 are described in detail in the CBL-514 IB. 
The mechanism of action of CBL-514 is to trigger adipocyte apoptosis by inhibition of 
DYRK1b, thereby increasing the expression of Caspase-3 and Bax/Bcl-2 ratio, which are 
apoptosis biomarkers. Our pervious nonclinical study results demonstrated that CBL-514 
induced cell death of adipocyte through apoptosis mechanism and reduced the subcutaneous fat 
in treatment area. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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6.2.2. 
Clinical Studies 
The safety and tolerability of injection lipolysis with CBL-514, PK profile of and preliminary 
efficacy of 4 doses of CBL-514 in reducing abdominal subcutaneous fat at the target area was 
evaluated in a first-in-human, placebo-controlled, double-blind, Phase 1/2a study (CBL-16001) 
in Australia. In the Phase 1 component of CBL-16001, CBL-514 was administered in human for 
the assessment of safety and tolerability. The treatment was a SAD design in which 9 proposed 
dosing cohorts were involved (Cohorts 1 to 9). In 9 sequential cohorts, CBL-514 dose levels 
were 2 mg, 10 mg, 20 mg, 40 mg, 40 mg, 80 mg, 160 mg, 240 mg, and 320 mg per subject. For 
Cohorts 1 to 5, both CBL-514 and placebo groups were administered on each side of abdomen in 
a blinded manner to evaluate the possible AEs attributed to the components of CBL-514. For 
Cohorts 6 to 9, only CBL-514 was dosed in subjects. 
Overall, Phase 1 results in physical examination, vital signs, ECG, and laboratory tests, including 
biochemistry, hematology, coagulation, and urinalysis, all showed favorable profiles for the 
safety of CBL-514. While there was no systemic TEAE from CBL-514, the most frequent 
TEAEs were ISRs. 
 
 
 
 
 
 
 
 
 
 
 
 


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In the Phase 1 component of CBL-16001, CBL-514 was well tolerated through the ascending 
dose escalation scheme from 2 mg to 320 mg. 
6.3. 
Rationale for the Study 
To date, the nonclinical and clinical study data suggest that subcutaneous administration of 
CBL-514 may be effective in reducing subcutaneous fat in humans. The pharmacological studies 
conducted by Caliway Biopharmaceuticals support the intended clinical dose and route of 
administration of the planned Phase 2 study (refer to further details in IB). 
6.4. 
Dosage and Treatment Periods 
The study is divided into 2 stages: 
Stage 1 
Stage 1 will include a total of 24 subjects enrolled in 4 sequential escalating CBL-514 dose 
groups and will receive a single course of CBL-514: 320 mg, 480 mg, 640 mg, and 800 mg. 
The groups will be open label. The 4 groups will each include 6 subjects.  
Subjects in Group 1 (320 mg) will receive CBL-514 injections on thighs, with total allocated 
dose of IP evenly divided into 2 thighs. Subjects from Group 2 to 4 (480 mg-800 mg) will 
receive CBL-514 injections on abdomen with allocated dose of IP. The dosing scheme is 
presented in Table 7. 
Stage 2 
In Stage 2 of the study, a total of 75 subjects will be randomized to 2:1 (i.e., 50 subjects in the 
CBL-514 group and 25 subjects in the placebo group). Each subject will receive up to 4 courses 
of CBL-514 or placebo. Each course of CBL-514/placebo will be administered 4 weeks apart, 
over a period of up to 12 weeks. Only a single dose level of CBL-514 will be administered in 
Stage 2, which will be set no higher than the highest safe dose from Stage 1 of the study. 
6.4.1. 
Rationale for Dose Selection 
The maximum dose of this Phase 2 study is estimated based on the 8-week repeated-dose GLP 
toxicity studies in Sprague-Dawley rats and Beagle dogs, respectively. 
 
 
 
 
 
 
 
 
 
 


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Furthermore, the completed Phase 1/2a Study (protocol number: CBL-16001) had evaluated the 
safety of CBL-514 injection for reducing abdominal subcutaneous fat. Single treatment of 
CBL-514 were administered with dose levels of 2 mg, 10 mg, 20 mg, 40 mg, 80 mg, 160 mg, 
240 mg, and 320 mg per subject, which have shown overall favorable results in physical 
examination, vital signs, ECG, laboratory tests including biochemistry, hematology, coagulation, 
and urinalysis profiles. 
There was no systemic TEAEs from CBL-514, the most frequent TEAEs were ISRs. During 
SAD progress, the severity and duration of common ISRs did not show apparent difference 
among cohorts, which provided even more evidence on the safety of CBL-514 in human. 
Based on the nonclinical and clinical results above, the dose escalation groups in the present 
study are structured as 320 mg, 480 mg, 640 mg, and 800 mg to assess safety and tolerability of 
higher doses of CBL-514 when injected in abdominal or thigh adipose tissue. 
The doses used in this study are 2 mg/cm2, which are all within the pharmacologically active 
dose range. (Please refer to IB for more details) Moreover, the Phase 1 component of CBL-
16001 study have assessed safety in human from 0.5 ~ 2 mg/cm2 with favourable safety profiles. 
Based on the results of the CBL-16001 Phase 1 study, the incidence of TEAEs reported were 
similar across all dose cohorts especially in Cohort 5 to 9, where subjects received the same unit 
dose (2 mg/cm2) over an increasing treatment area/ total dose per Cohort. Therefore, CBL-0202 
has adopted the similar design to have a consistent unit dose, 2 mg/cm2, throughout the study. It 
is expected that the severity or incidence of adverse events in CBL-0202 study will not increase 
compared to the completed study, even though the dose used is higher.  
The purpose of increasing the total dose in CBL-0202 study is to accommodate the larger 
treatment area needed to cater different needs of subjects due to various shape of abdomen/ 
thighs and level of fat accumulation, so as to reach meaningful efficacy and to also improve on 
the overall appearance and shape to achieve aesthetically pleasing result for the subjects. 
6.5. 
Subject Population 
The study will be conducted in male and female subjects aged 18 to 64 years (inclusive at the 
time of informed consent) with  
• 
thigh subcutaneous fat thickness of at least 1.00 cm (10.0 mm) and up to 4.00 cm (40.0 mm) 
measured by ultrasound at Screening and Day 1 for Group 1 in Stage 1,  
• 
abdominal subcutaneous fat thickness of at least 2.00 cm (20.0 mm) and up to 5.00 cm (50.0 
mm) measured by ultrasound at Screening and Day 1 for Group 2-4 in Stage 1, 
• 
and abdominal skinfold thickness of at least 3.00 cm (30.0 mm) and up to 8.00 cm (80.0 
mm) by pinch method (measured by calibrated caliper) at Screening for Stage 2. 


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Women of childbearing potential (WOCBP) will be included and are subject to contraceptive 
requirements during the study from Screening until study completion, including the follow-up 
period, and for at least 90 days after the last dose of IP (see Section 9). WOCBP must 
demonstrate negative pregnancy testing at Screening and before administration of IP. This is in 
line with regulatory Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical 
Trials and Marketing Authorization for Pharmaceuticals (FDA 2006). 
6.6. 
Ethical Principles 
This study will be conducted in accordance with the principles of the current Declaration of 
Helsinki (Ethical Principles for Medical Research Involving Human Subjects). The conduct of 
the study will be in accordance with the International Conference for Harmonisation (ICH) 
Integrated Addendum to E6(R1): Guideline for ICH GCP E6(R2), annotated with comments by 
the Australian Therapeutic Goods Administration (TGA; 2018). 
This study will be conducted under a protocol reviewed and approved by an IRB/IEC and 
investigations will be undertaken by scientifically and medically qualified persons; where the 
benefits of the study are in proportion to the risks. 


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7. 
TRIAL OBJECTIVES AND PURPOSE 
7.1. 
Objectives 
7.1.1. 
Primary Objectives 
7.1.1.1. 
Stage 1 
The primary objective of Stage 1 of the study is to: 
• 
Evaluate the safety and tolerability of injection lipolysis with CBL-514 
7.1.1.2. 
Stage 2 
The primary objectives of Stage 2 of the study are to: 
• 
Assess the proportion of subjects who lose at least 150 mL of subcutaneous fat 
volume as measured by ultrasound compared with placebo 
7.1.2. 
Secondary Objectives 
7.1.2.1. 
Stage 1 
The secondary objectives of Stage 1 of the study are to: 
• 
Assess the efficacy of single course of CBL-514 at applicable dose levels in reducing 
subcutaneous fat over the treated area as measured by ultrasound compared with 
Baseline. 
*Note: no efficacy endpoints/objectives will be assessed for Group 1 of Stage 1 study. 
7.1.2.2. 
Stage 2 
The secondary objectives of Stage 2 of the study are to: 
• 
Assess the proportion of subjects who lose at least 200 mL of subcutaneous fat 
volume as measured by ultrasound compared with placebo 
• 
Evaluate the number of treatments required to first occurrence of reducing at least 
150 mL of subcutaneous fat volume over the treated area as measured by ultrasound 
in CBL-514 group 
• 
Assess the efficacy of up to 4 courses of CBL-514 in reducing subcutaneous fat 
volume over the treated area as measured by ultrasound compared with placebo 
• 
Assess the efficacy of up to 4 courses of CBL-514 in reducing subcutaneous fat 
volume over the treated area as measured by ultrasound compared with Baseline 
• 
Evaluate safety following up to 4 courses of CBL-514 when compared with placebo 


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7.2. 
Endpoints 
7.2.1. 
Primary Endpoints 
7.2.1.1. 
Stage 1 
The primary endpoints of Stage 1 of the study are: 
• Safety and tolerability following single dose of CBL-514 as assessed by recording of 
TEAEs, laboratory assessments, vital signs, ECGs, physical examinations, and injection 
site assessment. 
7.2.1.2. 
Stage 2 
The primary endpoints of Stage 2 of the study are: 
• The proportion of subjects who lose at least 150 mL of subcutaneous fat as measured by 
ultrasound from Baseline to follow-up visits compared with placebo.  
[Time frame: Visit 2 (Baseline), Visit 6 and Visit 7] 
7.2.2. 
Secondary Endpoints 
7.2.2.1. 
Stage 1 
The secondary endpoints of Stage 1 of the study are: 
• Reduction of subcutaneous fat thickness as measured by ultrasound compared with 
Baseline. [Time frame: Day 1 and Week 4] 
• Reduction of subcutaneous fat volume over the treated area as measured by ultrasound 
compared with Baseline. [Time frame: Day 1 and Week 4] 
*Note: no efficacy endpoints/objectives will be assessed for Group 1 of Stage 1 study. 
7.2.2.2. 
Stage 2 
The secondary endpoints of Stage 2 of the study are: 
• The proportion of subjects who lose at least 200 mL of subcutaneous fat as measured by 
ultrasound from Baseline to follow-up visits compared with placebo.  
[Time frame: Visit 2 (Baseline), Visit 6 and Visit 7] 
• Number of treatments required to first occurrence of reducing at least 150 mL of 
subcutaneous fat volume over the treated area as measured by ultrasound in CBL-514 
group 
[Time frame: from Visit 2 (Baseline) to Visit 7] 
• Reduction of subcutaneous fat volume over the treated area as measured by ultrasound 
from Baseline to follow-up visits compared with placebo. [Time frame: Visit 2 
(Baseline), Visit 6 and Visit 7] 
• Reduction of subcutaneous fat volume over the treated area of the CBL-514 group as 
measured by ultrasound compared with individual Baseline. [Time frame: Visit 2 
(Baseline), Visit 3, Visit 4, Visit 5, Visit 6, and Visit 7] 


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• Safety as assessed by recording of TEAEs, laboratory assessments, vital signs, ECGs, 
physical examinations, and ISRs compared with placebo 


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8. 
INVESTIGATIONAL PLAN 
8.1. 
Overall Study Design 
This is a 2-stage adaptive design, Phase 2 study to evaluate the efficacy, safety, and tolerability 
of CBL-514 injection for reducing abdominal or thigh subcutaneous fat. This Phase 2 study has 
an integrated design consisting of a SAD part in Stage 1. Stage 2 will be conducted as a single-
blind, placebo-controlled study, with 1 treatment group and 1 placebo group. A total of 
approximately 99 adult subjects with  
• 
thigh subcutaneous fat thickness of at least 1.00 cm (10.0 mm) and up to 4.00 cm (40.0 mm) 
measured by ultrasound at Screening and Day 1, for Group 1 in Stage 1,  
• 
abdominal subcutaneous fat thickness of at least 2.00 cm (20.0 mm) and up to 5.00 cm (50.0 
mm) measured by ultrasound at Screening and Day 1 for Group 2-4 in Stage 1, 
• 
and abdominal skinfold thickness of at least 3.00 cm (30.0 mm) and up to 8.00 cm (80.0 
mm) by pinch method (measured by calibrated caliper) at Screening for Stage 2, 
will be enrolled across the 2 stages of the study. 
Stage 1 (single dose, open label, dose escalation) 
Stage 1 will include a total of 24 subjects enrolled in 4 sequential escalating CBL-514 dose 
groups and will receive a single course of CBL-514: 320 mg, 480 mg, 640 mg, and 800 mg. 
The groups will be open label. The 4 groups will each include 6 subjects.  
Subjects in Group 1 (320 mg) will receive CBL-514 injections on thighs, with total allocated 
dose of IP evenly divided into 2 thighs. Subjects from Group 2 to 4 (480 mg-800 mg) will 
receive CBL-514 injections on abdomen with allocated dose of IP. 
Based upon SRC recommendation intermediate doses may be explored. 
The dosing scheme is presented in Table 7. 
A schematic of the study design is provided in Figure 1. Local effects of CBL-514 injection will 
be evaluated, and blood samples will be taken and analyzed to assess the safety of IP. 
Subjects will be screened for inclusion and exclusion criteria during a 28-day screening period 
(Day -28 to Day -1). At the Treatment visit (Day 1), eligible subjects will be sequentially 
assigned to receive 1 course of allocated CBL-514 dose. 
Subjects will visit the site on each of the study visits. Subjects will remain onsite for observation 
for at least 1 hour after the administration of CBL-514, or longer at the discretion of the 
Investigator and until all planned assessments for the visit are completed. 
Subjects who are withdrawn from the study earlier than planned should attend an ET visit as 
soon as possible after early withdrawal, no later than 6 weeks from the last dose received. 
A subject diary will be provided to each subject, to record if there are any changes to the 
injection site/s or any discomforts from Day 1 until last clinic visit or when all ISRs have 
resolved or stabilized. Subjects will be instructed to bring the subject diary with them for all 
visits to the clinic. 


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During Stage 1 of the study, the SRC will meet after all subjects in a dose group have completed 
the Week 1 visit. The SRC will review all reported AEs, AESIs, laboratory trends, and vital signs 
of all subjects from each dose group. Based upon review of available safety and tolerability data 
from each preceding dose group, the SRC will make a decision on progressing to the next dose 
group. 
The safety and tolerability data of CBL-514 from Stage 1 will be reviewed by the SRC before 
commencement of Stage 2 (see Section 8.3). A top-level summary of safety data will be 
submitted to the relevant IRB/IEC for review before proceeding to Stage 2 of the study. 
Study visits and assessments for Stage 1 of the study will occur as delineated in the Schedule of 
Assessments (Table 4). 
Stage 2 (multiple-dose, randomized, single-blind, parallel, placebo-controlled study) 
Stage 2 will be conducted as a single-blind study, with 1 CBL-514 group and 1 placebo group. 
Each subject will receive up to 4 treatments of allocated CBL-514 (2 mg/cm²) or placebo 
administered on abdomen, once every 4 weeks. The minimum dose is 300 mg per treatment and 
the maximum dose is 600 mg per treatment. The dose adjustment will depend on the level of fat 
accumulation on subject’s abdomen at the discretion of the Investigator. 
Stage 2 of the study will be initiated after IRB/EC review of top-level summary of safety data 
from Stage 1 of the study. The dose for Stage 2 will be based on a review of the safety data from 
Stage 1 of the study and the dose for Stage 2 will be set no higher than the highest safe dose from 
Stage 1. 
In Stage 2, subjects will be randomized 2:1 CBL-514 group vs placebo group. Considering drop-
out rates, approximately 75 subjects will be enrolled (50 subjects in the CBL-514 group and 25 
subjects in the placebo group) in order to have 56 evaluable subjects for the 2 groups. 
Subjects should have sufficient subcutaneous fat on their abdomen to receive injections on Day 
1. This will be based on eligibility criteria set out in inclusion criterion 3. Before administration, 
the Investigator should evaluate whether a subject is able to receive the minimum dose, 300 mg 
(25 injections) as defined by Study Drug Administration Manual.
 
 If a subject is not able to receive the minimum injection 
dose, the ongoing treatment and post-dose assessments will be cancelled and the remaining 
treatment visits would not be required for that subject. For subjects that do not complete 4 
treatments due to not enough residual fat, the subject will be requested to continue with follow-
up visits (Visit 6 and 7). This arrangement would not be regarded as missing protocol required 
visits, or as discontinuation from the study. 
If a subject cannot complete the 4 treatments and withdraws from the study because of reasons 
except for dose adjustment, only the ET visit should be performed for final follow-up. 
Subjects will be screened for inclusion and exclusion criteria during a 28-day screening period 
(Day -28 to Day -1). At Visit 2 (Day 1), eligible subjects will be randomized 2:1: (i.e., CBL-514 
group: 50 subjects; placebo group: 25 subjects) to receive CBL-514 or placebo, respectively.  
Subjects will visit the site on each of the study visits and will remain onsite for observation for 
1 hour after the administration of the IP, or shorter/ longer at the discretion of the Investigator 
and until all planned assessments for the visit are completed. 


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An ET visit has been planned for subjects who are withdrawn from the study earlier than planned 
for assessment as soon as possible after early withdrawal, no later than 6 weeks from the last 
dose received. 
A subject diary will be provided to each subject to record if there are any changes to the injection 
site/s or any discomforts in between visits. Subjects will be instructed to bring the subject diary 
with them for all visits to the clinic. 
Study visits and assessments for Stage 2 of the study will occur as delineated in the Schedule of 
Assessments presented in Table 5. 
8.2. 
Number of Subjects 
Approximately 99 adult male or female subjects, will participate in the study. A total of 24 
subjects are planned to be enrolled in 4 sequential groups in Stage 1 of the study. Considering 
drop-out rates, approximately 75 subjects are planned to be enrolled and randomized 2:1 (i.e., 50 
subjects in the CBL-514 group and 25 subjects in the placebo group) in order to have 56 
evaluable subjects in Stage 2 of the study. The sample size for stage 2 of the study was 
calculated based on currently accepted standards for exploratory investigation design. 
8.3. 
Dose Adjustment and Safety Oversight 
Study drug administration should be in accordance with dose scheme. The deviation of 
administration will potentially affect the study drug efficacy. The following major deviations will 
be deemed to have an influence on efficacy. Effort should be made to adhere to study design. 
1. 
Subject who is assigned to wrong dose group 
2. 
Subject with dosing compliance* less than 90% or more than 110% of total dosage per 
treatment (except for the subject who has dose adjustment judged by the Investigator#). 
*Compliance is defined as the taken dosage out of the total dose in the assigned dose group or 
number of injections out of the amount required per treatment in accordance with protocol. 
#During Stage 2, before administration, the Investigator should evaluate whether a subject is able 
to receive the minimum dose, 300 mg (25 injections) as defined by Study Drug Administration 
Manual. 
 If a subject is not able to 
receive the minimum dose, the ongoing treatment and post-dose assessments will be cancelled, 
and the remaining treatment visits would not be required for that subject. For subjects that do not 
complete 4 treatments due to not enough residual fat, the subject will be requested to continue 
with follow-up visits (Visit 6 and 7). This arrangement would not be regarded as missing 
protocol required visits, or as discontinuation from the study. 
Oversight will be provided by an SRC comprising the Investigator, the Sponsor’s Representative 
and MM. The SRC will be established prior to Screening. The details of SRC will be set out in 
an SRC Charter. 
During Stage 1 of the study, the SRC will meet after all subjects in a dose group complete the 
Week 1 visit. The SRC will review all reported AEs, AESIs, laboratory trends, and vital signs of 
all subjects from each dose group. Based upon review of available safety and tolerability data 
from each preceding dose group, the SRC will make a decision on progressing to the next dose 
group. 


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Before commencement of Stage 2, the SRC will review safety data. A top-level summary of 
safety data will be submitted to the relevant IRB/IEC for review before proceeding to Stage 2 of 
the study. 
In addition, the occurrence of any of AESI or any AE that, based on the judgment of 
Investigator, raises medical concern, will trigger a review by the SRC before proceeding with 
dose escalation/s in Stage 1 or course of treatment in Stage 2. 
For the SRC meeting, safety assessments will include the following: 
• 
Incidence of all AEs 
• 
AESI 
• 
Changes from Baseline in clinical laboratory test results 
• 
Changes from Baseline in vital signs. 
If at any time the study is terminated, a written statement fully documenting the reasons for 
termination will be provided to the relevant IRB/IEC (see Section 8.5). 
8.4. 
Stopping Criteria 
Administration of IP in a dose group may be paused, and additional subjects will not receive 
further treatments, until a consultation has taken place between the Investigator, the MM, and the 
Sponsor representative under the following circumstances: 
• 
Any subject experiences an adverse event as Grade 3 (as defined in the NCI-CTCAE 
version 5.0) for cardiovascular, renal or hepatic event considered to be at least 
possibly related to IP,  
• 
Except for cardiovascular, renal, or hepatic events specified in Criterion #1, any 
participant experiences an AE as Grade 4 and considered to be at least possibly 
related to IP 
• 
Any subject experiences an SAE that is considered to be at least possibly related to 
the IP 
• 
An AE or group of AEs that singularly or in aggregate suggests to the Investigator or 
Sponsor that the IP is poorly tolerated and further treatment PP may not be safe. 
If any of these criteria occur, consultation between the Sponsor representative, the Investigator, 
and the MM will take place as soon as possible to evaluate the event. Subjects should remain in 
the study and be followed until the adverse event resolves or stabilizes. 
 
8.5. 
Criteria for Study Termination 
The study will be completed as planned unless: 
• 
New information or other evaluation regarding the safety or efficacy of the IP 
indicates a change in the known risk/benefit profile for the compound, such that the 
risk/benefit is no longer acceptable for subjects participating in the study. This may 


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be determined by the Sponsor, the Investigator, the IRB/IEC, or regulatory 
authorities. 
• 
The study is terminated by the Sponsor for administrative reasons. 
The Sponsor, Investigator, the IRB/IEC and the regulatory authority reserve the right to 
terminate or suspend the study at any time; however, termination or suspension of the study 
should be discussed between the relevant parties beforehand and the reason for such decision 
recorded. Should this occur, all data available will also be recorded in the eCRFs. If the Sponsor, 
the IRB/IEC, or regulatory authority elects to terminate or suspend the study or the participation 
of the investigational site, a study-specific procedure for ET or suspension will be provided by 
the Sponsor. The procedure will be followed by the investigational site during termination or 
study suspension. 
The Investigator should notify the relevant the IRB/IEC and/or regulatory authority in writing of 
the study’s completion or early discontinuation. 
 


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Figure 1: Study Design 
Stage 1 
 
 
 
 
 
 


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Stage 2 
 
 
 




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Assessment  
Screening 
Treatment 
Follow-up 
Stage 1 
Screening 
Day 1* 
Week 1 
Week 2 
Week 4 
Day 
-28 to -1 
1 
8 ± 4 days 
15 ± 4 days 
29 ± 4 days 
Visit 
1 
2 
3 
4/ ET 
5 /EOS 
IP Administration 
 
X 
 
 
 
Photography13 
 
X 
X 
X 
X 
AE14 
 
X 
X 
X 
X 
Concomitant Medication 
 
X 
X 
X 
X15 
AE: Adverse event; AESI: Adverse event of special interest; Ag/Ab: Antigen/antibody; ALP/ALKP: Alkaline phosphatase; ALT: 
Alanine aminotransferase; aPTT: Activated partial thromboplastin time; AST: aspartate aminotransferase; β-hCG: Beta 
human chorionic gonadotropin; ECG: Electrocardiogram; eGFR: Estimated glomerular filtration rate; EOT: End of treatment: 
EOS: End of study; ET: Early Termination; FBS: Fasting blood sugar; GGT: Gamma-glutamyl transferase; Hb: Hemoglobin; 
HbA1c: Hemoglobin A1c; HBV: Hepatitis B Virus; Hct: Hematocrit; HCV: Hepatitis C Virus; HDL-C: High-density 
lipoprotein cholesterol; HIV: Human immunodeficiency virus; INR: International normalized ratio; IP: Investigational 
product; ISR: Injection site reaction; LDL-C: Low-density lipoprotein cholesterol; RBC: Red blood cell; SAE: Serious 
adverse event; TBIL: Total bilirubin; WBC: White blood cell; WOCBP: Woman of childbearing potential. 
* Available measurements of clinical evaluations (physical examinations, vital signs, and ECG) and laboratory evaluations 
(biochemistry, hematology, coagulation, and urinalysis) within 14 days prior to IP dose can be accepted as the Baseline value 
and will not necessitate duplicate examinations. 
* If study drug dose is within 7 days of Screening pregnancy test, pregnancy test at Visit 2 (Day 1) will not be necessary to 
assess. 
* In cases where more than 1 data is available for a certain evaluation, the latest value prior to the study drug administration will 
be used as the Baseline value. 
1 
Details of concurrent medical conditions, prior surgical procedures, and chronic diseases or other significant medical events 
prior to Screening will be collected. Any other non-significant medical events within 6 months prior to Screening will also be 
collected. Prior medications include a complete history of previous treatment/medications within 6 months prior to Screening. 
2 
Subject diaries will be provided to the subjects on Day 1. The subjects will be asked to record if there are any changes to the 
injection site/s or any discomforts from Day 1 until last clinic visit or when all ISRs have resolved or stabilized. The diary 
will be reviewed at the following visits as needed. 
3 
Anthropometric parameters to be collected include body height and body weight.  Body height will be measured at Screening 


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only. Thigh circumference will be collected only for Group 1 (320 mg) in Stage 1 study. 
4 
Ultrasound – Thickness of fat will be obtained by ultrasonic measurements across target area. Abdominal or thigh ultrasound 
will be performed at Screening, Day 1, and Week 4. Abdominal or thigh ultrasound may be performed within 4 days before 
Day 1 and up to 4 days before/after Week 4 follow-up visit. Day 1 ultrasound can be exempted if the screening ultrasound is 
performed within 4 days prior to IP dose, and the screening ultrasound can be accepted as the Baseline value. 
5 
A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, 
and neurological systems. 
6 
On Day 1, injection site assessments will be performed pre-dose and at 1-hour post-dose. 
7 
On Day 1, vital signs assessments to be performed pre-dose and at 1-hour post-dose. Vital sign assessments include 
temperature, pulse rate, blood pressure, and respiratory rate. At simultaneously scheduled assessments, vital signs will be 
collected prior to any blood draws. 
8 
On Day 1, ECG assessments will be performed pre-dose only. ECG to be performed in supine position after at least 5 minutes 
rest. The following ECG parameters will be recorded: heart rate, RR interval, PR interval, QT interval, QTc interval, and QRS 
interval. 
9 
Blood tests include biochemistry, hematology, and coagulation assessments. Biochemistry assessments include albumin, ALT, 
AST, ALP, triglyceride, total cholesterol, LDL-C, HDL-C, TBIL, GGT, urea, creatinine, eGFR, HbA1c, FBS, Sodium, 
Potassium, Bicarbonate, and Chloride. Hematological assessments include Hb, Hct, RBC count, mean corpuscular volume, 
Leukocyte/white blood cell (WBC) count, WBC differential, and platelet count. Coagulation assessments include aPTT, 
Prothrombin time, and INR. 
10 Urinary samples for dipstick will be collected. On Day 1, collection will be performed pre-dose only. 
11 Serum β-hCG test will be taken for WOCBP at Screening visit only. FSH test is required for females who are post-
menopausal at the Screening visit. Urine β-hCG strip test will be taken WOCBP for other scheduled visits. 
12 Virology tests include HIV/HBV/HCV infection test. Active HIV infection is detected by detectable positive HIV Ag/Ab 
combo test; active HBV: HBsAg; active HCV: positive anti-HCV antibody. 
13 On Day 1, photography will be performed pre-dose and at 1 hour post-dose on Day 1. Other timepoints on Day 1 can be 
added to record the ISR at the discretion of the Investigator. 
14 The occurring AEs/SAEs (including AESI) will be followed until resolution or the event is considered stable. 
15 Collected only if a medication is related to AEs following the visit 4. 
16 Assessment/collection can be performed on or within 4-days window prior to visit date. 
17 Abdominal or thigh ultrasound only applicable to ET visit and not required for Week 2 visit. 
18 At Week 1, only body weight will be measured and collected for anthropometric parameter. 




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AE: Adverse event; AESI: Adverse event of special interest; Ag/Ab: Antigen/antibody; ALP/ALKP: Alkaline phosphatase; ALT: 
Alanine aminotransferase; aPTT: Activated partial thromboplastin time; AST: aspartate aminotransferase; β-hCG: Beta 
human chorionic gonadotropin; BMI: Body mass index; ECG: Electrocardiogram; eGFR: Estimated glomerular filtration 
rate; EOT: End of treatment: EOS: End of study; ET: Early Termination; FBS: Fasting blood sugar; FSH: Follicle stimulating 
hormone; GGT: Gamma-glutamyl transferase; Hb: Hemoglobin; HbA1c: Hemoglobin A1c; HBV: Hepatitis B Virus; Hct: 
Hematocrit; HCV: Hepatitis C Virus; HDL-C: High-density lipoprotein cholesterol; HIV: Human immunodeficiency virus; 
INR: International normalized ratio; ISR: Injection site reaction; LDL-C: Low-density lipoprotein cholesterol; RBC: Red 
blood cell; SAE: Serious adverse event; TBIL: Total bilirubin; WBC: White blood cell; WOCBP: Woman of childbearing 
potential. 
* Available measurements of clinical evaluations (physical examinations, vital signs, and ECG) and laboratory evaluations 
(biochemistry, hematology, coagulation, and urinalysis) within 14 days prior to CBL-514 or Placebo dose can be accepted as 
the Baseline value and will not necessitate duplicate examinations. 
*  If study drug dose is within 7 days of Screening pregnancy test, pregnancy test at Visit 2 (Day 1) will not be necessary to 
assess. 
*  In cases where more than 1 data is available for a certain evaluation, the latest value prior to the study drug administration 
will be used as the Baseline value. 
Assessment/Schedule 
Screening 
Treatment 
Follow-up 
Visit 
1 
2 
3 
4 
5/EOT 
**6/ET 
7/EOS 
Day 
-28 to -1 
1* 
(Visit 2 + 4 
weeks) 
(Visit 3 + 4 
weeks) 
(Visit 4 + 4 
weeks) 
(Visit 5 + 4 
weeks) 
(Visit 5 + 8 
weeks) 
Visit window 
 
- 
+ 7days 
+ 7days 
+ 7days 
± 7days 
± 7days 
Pregnancy Status10 
X 
X16 
X16 
X16 
X16 
X16 
 
Virology11 
X 
 
 
 
 
 
 
Photography12 
 
X 
X 
X 
X 
X 
X 
Randomization 
 
X 
 
 
 
 
 
CBL-514 or Placebo 
Administration17 
 
X 
X 
X 
X 
 
 
Adverse Events13 
 
X 
X 
X 
X 
X 
X 
Concomitant Medication 
 
X 
X 
X 
X 
X 
X15 


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** The first follow up visit (Visit 6) should be performed 4 weeks post the final treatment. If treatment is cancelled at Visits 3, 4 
or 5 due to the insufficient abdominal fat, it is recommended that first follow up visit is performed on the same day of the 
treatment cancellation. If not, then +7 days visit window should be utilized to schedule another day to complete the first 
follow up visit. 
1 
Details of concurrent medical conditions, prior surgical procedures and chronic diseases or other significant medical events 
prior to Screening will be collected. Any other non-significant medical events within 6 months prior to Screening will also be 
collected. Prior medications include a complete history of previous treatment/medications within 6 months prior to Screening. 
2 
Anthropometric parameters include body height, body weight and abdominal skinfold thickness measured by caliper. Body 
weight will be measured at all visits to calculate the BMI. Body height and abdominal skinfold thickness (by caliper) will be 
measured at Screening only. 
3 
Ultrasound – Thickness of fat will be obtained by ultrasonic measurements across target area. Abdominal ultrasound will be 
performed within 4 days before Visit 2 (Day 1), Visits 3, 4 and 5; and 4 days before/after the follow-up visits. 
4 
A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, 
and neurological systems and will be performed pre-dose. 
5 
On Visit 2 (Day 1), Visit 3, Visit 4, and Visit 5, the injection site assessments will be performed pre-dose and post-dose. 
Subjects will document any change to the ISRs in between visits in the Subject Diaries. 
6 
On Visit 2 (Day 1), Visit 3, Visit 4, and Visit 5, vital signs assessments to be performed pre-dose. Vital sign assessments 
include temperature, pulse rate, blood pressure, and respiratory rate. 
7 
On Visit 2 (Day 1), ECG assessments will be performed pre-dose. ECG to be performed in supine position after at least 5 
minutes rest. The following ECG parameters will be recorded: heart rate, RR interval, PR interval, QT interval, and QRS 
interval. 
8 
Blood tests include biochemistry, hematology, and coagulation assessments. Biochemistry assessments include albumin, ALT, 
AST, ALP, triglyceride, total cholesterol, LDL-C, HDL-C, TBIL, GGT, urea, creatinine, eGFR, HbA1c, FBS, Sodium, 
Potassium, Bicarbonate, and Chloride. Hematological assessments include Hb, Hct, RBC count, mean corpuscular volume, 
WBC count, WBC differential, and platelet count. Coagulation assessments include aPTT, Prothrombin time, and INR. 
9 
Urinary samples for dipstick will be collected. 
10 Serum β-hCG test will be taken for WOCBP at Screening visit only. FSH test is required for females who are post-
menopausal at Screening visit. Urine β-hCG strip test will be taken for WOCBP for other scheduled visits. 
11 Virology tests include HIV/HBV/HCV infection test. Active HIV infection is detected by detectable positive HIV Ag/Ab 
combo test; HBV: HBsAg; HCV: positive anti-HCV antibody. 
12 On Visit 2 (Day 1), Visit 3, Visit 4, and Visit 5, the photography will be performed pre-dose. The post-dose photography will 
be performed only when any severe or unusual ISR was observed and assessed by Investigator after IP administration.  
13 The occurring AEs/SAEs (including AESI) will be followed until resolution or the event is considered stable. 


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14 On follow-up visits, no subject diary will be provided to subjects and only review and recording of subject dairy entries will 
be conducted. 
15 Collected only if a medication is related to AEs following the Visit 6 
16 Assessment/collection can be performed on or within 4-days window prior to visit date. 
17 Eligible subjects will be randomly assigned to either the CBL-514 group or placebo group at a ratio of 2:1.  
18 ECG assessment can be performed on or within 4 days before or after Visit 6/ET 


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9. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
9.1. 
Subject Inclusion Criteria 
To be eligible for this study, a subject must meet all of the following inclusion criteria: 
1. Male or female, aged 18 years to 64 years old (at Screening), inclusive. 
2. BMI > 18.5 and < 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1. 
3. Subject has subcutaneous fat thickness surrounding the center of localized area of 
treatment. 
a. For Group 1 (320 mg) in Stage 1, thigh subcutaneous fat thickness of at least 1.00 cm 
(10.0 mm) and up to 4.00 cm (40.0 mm) measured by ultrasound at Screening and 
Day 1.  
b. For Group 2-4 (480 mg-800 mg) in Stage 1, abdominal subcutaneous fat thickness of 
at least 2.00 cm (20.0 mm) and up to 5.00 cm (50.0 mm) measured by ultrasound at 
Screening and Day 1. 
c. For Stage 2, abdominal skinfold thickness of at least 3.00 cm (30.0 mm) and up to 
8.00 cm (80.0 mm) by pinch method (measured by calibrated caliper) at Screening. 
4. Subject has stable body weight (identified as ≦ 5% weight change per subject report) for 
at least 3 months before Screening and during the study. 
5. Subject who has maintained a stable lifestyle (e.g. exercise, eating patterns, and smoking 
habit) per subject report for at least 3 months before Screening and during the study. 
6. Voluntarily signs the ICF and, in the opinion of the Investigator or delegate, is physically 
and mentally capable of participating in the study, and willing to adhere to study 
procedures. 
9.2. 
Subject Exclusion Criteria 
A subject who meets any of the following exclusion criteria must be excluded from the study: 
1. Female subject of childbearing potential who is not willing to commit to an acceptable 
contraceptive regimen with her partner from the time of Screening and throughout study 
participation until 90 days after the last IP dose, or who is currently pregnant or lactating. 
Male subject who is not willing to commit to an acceptable contraceptive method. For 
details on contraception, refer Section 9.3.2. 
Note: Subjects who are not of childbearing potential are not required to use 
contraception. Females with no childbearing potential are defined as who have been 
surgically sterilized (hysterectomy or bilateral oophorectomy) or who are post-
menopausal (defined as at least 50 years with ≥ 12 months of amenorrhea with a FSH 
> 40 IU/L).  


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2. Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet 
therapy or medications or dietary supplements, which impede coagulation or platelet 
aggregation. 
3. Subject has HbA1c ≥ 9%, delayed wound healing, or any diabetic risks which in the 
opinion of Investigator is inappropriate to participate in the study. 
4. Subject has a clinically significant cardiovascular disease and abnormal findings in ECG. 
5. Subject with active or prior history of malignancies within 5 years before Screening or 
being worked-up for a possible malignancy. Except adequately treated basal cell 
carcinoma of skin and in situ squamous cell carcinoma of skin would be eligible as per 
Investigator’s discretion. 
6. Subject with a history of HIV-1infection or subjects with active HIV infection at 
Screening with positive HIV Ag/Ab combo test. 
7. Subject with a history of Trypanophobia, the extreme fear of medical procedures 
involving injections or needles, or who experience vasovagal syncope and faint or pass 
out at the sight of blood or a needle. 
8. Subject has abnormal skin or local skin conditions at the treatment area, which in the 
opinion of Investigator is inappropriate to participate in the study, including but not 
limited to any of the following: 
a. Skin manifestations of a systemic disease, 
b. Any abnormality of the skin or soft tissues of the area to be treated, 
c. Grade III cellulite (Nürnberger and Muller scale, Nürnberger F, 1978) at the area to 
be treated, 
d. Skin folding and fat folding on abdomen 
e. Sensory loss or dysesthesia in the area to be treated, 
f. Evidence of any cause of enlargement in the area to be treated other than localized 
abdominal or thigh subcutaneous fat, 
g. Tattoos on the area to be treated. 
9. Subject who has undergone the following procedures: 
a. Previous surgery which caused scar tissues on the anticipated treatment area before 
Screening or during the study, except laparoscopic surgery and surgery which causes 
very small scar tissues would be eligible as per Investigator’s discretion, 
b. Liposuction to the region to be treated before Screening or during the study, 
c. Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, LLLT, lipolysis injection to 
the region to be treated within 12 months before Screening or during the study. 
d. Using medication which is delivered via subcutaneous injection at the treatment area 
during the study period. 
10. Subject is on prescription or OTC weight reduction medication or weight reduction 
programs within 3 months before Screening or during the study. 


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11. Subject is undergoing chronic steroid or immunosuppressive therapy, with the exception 
of oral steroid inhalation indicated for asthma management or topical steroid application 
for skin conditions that are not directly applied or indirectly affect the treatment area. 
12. Requiring continual use of the following therapeutic agents during the study: terfenadine 
(Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, 
Allegra, etc.), any medication that is known to strongly inhibit or induce CYP enzymes 
(please refer to Section 24.1), sensitive CYP substrates or drugs with narrow therapeutic 
index, in the opinion of the investigator, may affect the evaluation of the study product or 
place the participant at undue risk. 
If a subject needs to use the above mentioned therapeutic agents during the study for any 
reason, these therapeutic agents should not be used at least for 2 days prior to dosing and 
until 1 day post-dose. 
13. Unable to receive local anesthesia (e.g., history of hypersensitivity to lidocaine). 
14. Subjects with known allergies or sensitivities to the study treatment or its components. 
15. Subjects with liver cirrhosis, with inadequate liver function at Screening defined as AST, 
ALT, ALKP, TBIL, or GGT > 3.0 × ULN, or with any hepatic medical condition that 
would interfere with assessment of safety or efficacy or compromise the subject's ability 
to undergo study procedures or provide informed consent. 
16. Subjects with any renal impairment, defined as abnormal serum creatinine, and urea 
> 1.5 × ULN or eGFR <90 mL/min/1.73 m2. Subjects who are currently on dialysis 
should be excluded. 
Subjects with an eGFR ≥ 60 and < 90 mL/min/1.73 m2 at Screening should be evaluated 
by the Investigator to exclude pre-existing renal disease or associated dysfunction. If mild 
decrease in eGFR is assessed by the Investigator as not clinically significant or not 
related to dysfunction, the subjects may be eligible upon the Investigator’s assessment. 
17. Use of other investigational drug or device within 12 weeks prior to Screening. 
9.3. 
Prohibitions and Restrictions in the Study 
9.3.1. 
Medication 
During the entire duration of the study (from Screening visit to EOS/ET visit) use of following 
medications, treatment modalities, or diets are prohibited: 
a. Use of drugs for weight loss e.g. Orlistat (Xenical), Naltrexone HCl/Bupropion HCl 
(Contrave), etc., 
b. Use of anticoagulant/antiplatelet therapy or medications or dietary supplements which 
impede coagulation or platelet aggregation, 
c. Any cosmetic or interventional surgery procedures on area to be treated, 
d. Use of terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, 
Telfast, Xergic, Allegra, etc.), any medication that is known to strongly inhibit or 
induce CYP enzymes (please refer to Section 24.1), sensitive CYP substrates or drugs 
with narrow therapeutic index, in the opinion of the investigator, may affect the 
evaluation of the study product or place the participant at undue risk,  


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If a subject needs to use the above mentioned therapeutic agents during the study for 
any reason, these therapeutic agents should not be used at least for 2 days prior to 
dosing and until 1 day post-dose, 
e. Use of other investigational drug or device within 4 weeks prior to Screening. 
f. Use of medication which is delivered via subcutaneous injection at the treatment area 
during the study period. 
Subjects should be advised not to take any prescription and OTC medications without consulting 
the Investigator. 
9.3.2. 
Contraception 
Highly effective contraceptive methods that can achieve a failure rate of less than 1% per year 
when used consistently and correctly should be used. The list below is based on the 
recommendation of the Clinical Trial Facilitation Group (CTFG 2014). 
• combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulation: 
o oral 
o intravaginal 
o transdermal 
• progestogen-only hormonal contraception associated with inhibition of ovulation1: 
o oral 
o injectable 
o implantable1 
 intrauterine device (IUD)1 
• intrauterine hormone-releasing system (IUS)1 
 bilateral tubal occlusion1 
• vasectomized partner 1,2 
 sexual abstinence3 
 condom used by male partner during sexual intercourse. 
Contraceptive requirements for male subjects with WOCBP partner: A male subject should use 
condom during heterosexual intercourse and avoid sperm donation from the time of the first dose 
of study drug, throughout study participation until 12 weeks after the last study drug dose. For 
the WOCBP partner, contraception recommendations should also be considered. 
1 Contraception methods that in the context of this guidance are considered to have low user 
dependency. 
2 Vasectomized partner is a highly effective birth control method provided that partner is 
the sole sexual partner of the WOCBP trial participant and that the vasectomized partner 
has received medical assessment of the surgical success. 
3 In the context of this guidance, sexual abstinence is considered a highly effective method 
only if defined as refraining from heterosexual intercourse during the entire period of risk 
associated with the study treatments. The reliability of sexual abstinence needs to be 
evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle 
of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods) and 


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withdrawal (coitus interruptus) are not acceptable methods of contraception. This is 
applicable for both female and male subjects. 
9.4. 
Screen Failures 
Screen failures are defined as subjects who consent to participate in the clinical study but are not 
subsequently enrolled in the study. A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure subjects to meet the Consolidated Standards of 
Reporting Trials publishing requirements and to respond to queries from regulatory authorities. 
Minimal information includes screen failure details, eligibility criteria, and any SAE. Individuals 
who do not meet the criteria for participation in this study (screen failure) may be re-screened. 
Re-screening will be allowed once within the recruitment period for the study. Re-screened 
participants should be assigned a new screening number. 
9.5. 
Subject Replacement 
Subjects who are enrolled but who do not receive any IP will be replaced and the replacement 
subject will receive the same treatment as the subject they are replacing. Subjects who 
discontinue the study prior to completion of dosing may be replaced at the discretion of the 
Sponsor. 
9.6. 
Subject Withdrawal Criteria 
In accordance with applicable regulations, a subject has the right to withdraw from the study, at 
any time and for any reason, without prejudice to his (or her) future medical care. If a subject 
withdraws consent, the date and reason for consent withdrawal should be documented. Subject 
data will be included in the analysis up to the date of the withdrawal of consent. 
A subject must be removed from the study at any time, if any of the following criteria are met: 
Stage 1 
1. Subject withdraws consent. 
2. Between Screening and Day 1, subjects whose overall body weight change of ≥ 3kg. 
3. Subject has body weight change ≥ 5 % based on Day 1 body weight. 
4. Any other clinical AE, medical condition, or situation that in the opinion of the 
Investigator would not be in the best interest of the subject. 
5. Subject who cannot complete follow-up visits within 6 weeks post treatment visit. 
 
Stage 2 
1. Subject withdraws consent. 
2. Subject has body weight change ≥ 3 kg compared to Day 1 body weight during the whole 
study period. 
3. Subject has body weight change ≥ 3 kg during the follow-up period compared to the body 
weight from the last treatment visit. 


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4. Any other clinical AE, medical condition, or situation that in the opinion of the 
Investigator would not be in the best interest of the subject. 
5. Subjects has a treatment interval > 6 weeks in length between any of the dosing courses. 
6.  Subject cannot complete at least the first follow-up visit (Visit 6 / EOT) within 6 weeks 
post final treatment visit, or cannot complete the second follow-up visit (Visit 7 / EOS) 
within 10 weeks post final treatment visit. 
7. Subject has efficacy related major protocol violation at Day 1 (baseline) 
If a subject is withdrawn because of an AE, the Investigator must arrange for the subject to have 
appropriate follow-up care until the AE is resolved or has stabilized. Unresolved AEs will be 
followed until the EOS/ET visit or until the Investigator and MM determine that further 
follow-up is no longer indicated. 
If a subject asks or decides to withdraw from the study, the final ET evaluations (as per the 
schedule of study assessments) will be performed as completely as possible, all efforts will be 
made to complete and report the observations, especially the listed primary and secondary 
objectives, as thoroughly as possible up to the date of withdrawal. A clear and concise reason for 
withdrawal will be identified and recorded on the appropriate eCRF, along with the date of 
withdrawal. 


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10. 
INVESTIGATIONAL PRODUCTS 
10.1. 
CBL-514 
CBL-514 is a lipolysis injection product developed by Caliway Biopharmaceuticals Co., Ltd. 
CBL-514 are constituted by 
. 
CBL-514 is manufactured in compliance with Good Manufacturing Practice (GMP) regulations. 
Table 6: 
CBL-514 Product Details 
Name 
CBL-514 
Dosage Form  
Solution for Injection  
Dose Concentration per Vial  
5 mg/mL  
Size of Vial  
20 mL/vial  
Active Ingredient  
  
Mode of Administration  
Subcutaneous injection  
Storage  
Store at 4°C (39°F), Excursions are permitted 
between 2°C and 8°C  
10.2. 
Reference/Placebo 
The placebo to be used in the study will be commercially available (isotonic) Sodium Chloride 
for injection (0.9% NaCl). Equivalent volume of Sodium Chloride injection will be administered 
by subcutaneous injection. 
10.3. 
Dosage and Treatment Periods 
10.3.1. 
Stage 1 
A total of 24 subjects enrolled in 4 sequential groups (6 subjects in each group) in Stage 1 of the 
study, will receive 1 course of allocated CBL-514 dose once. Subjects in Group 1 (320 mg) will 
receive CBL-514 injections on their thighs, with total allocated dose of IP evenly divided into 2 
thighs. Subjects from Group 2 to 4 (480 mg-800 mg) will receive CBL-514 injections on their 
abdomen with allocated dose of IP. 
The dosing scheme is presented in Table 7. 
Table 7: 
Dosing Scheme-Stage 1 
Group 
Treatment 
area 
CBL-514 
Dose 
Level 
(mg/cm2) 
Injection 
volume per 
injection in 
4 cm2 grid 
space 
Administration for one dose 
No. of 
Injection 
Total Injection 
Volume of 
CBL-514* (mL) 
Total CBL-514 (mg) 
1 
Thighs 
2.0 
1.6 mL 
40 / 20  
64 / 32 
(total/ per thigh) 
320 
 
 


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Group 
Treatment 
area 
CBL-514 
Dose 
Level 
(mg/cm2) 
Injection 
volume per 
injection in 
4 cm2 grid 
space 
Administration for one dose 
No. of 
Injection 
Total Injection 
Volume of 
CBL-514* (mL) 
Total CBL-514 (mg) 
(total/ per 
thigh) 
2 
Abdomen 
2.0 
1.6 mL 
60 
96 
480 
 
 
3 
Abdomen 
2.0 
1.6 mL 
80 
128 
640 
 
 
 
4 
Abdomen 
2.0 
1.6 mL 
100 
160 
800 
 
 
 
*The concentration of CBL-514 is 5 mg/mL 
10.3.2. 
Stage 2 
Each enrolled Stage 2 subject will be randomized (2:1) to receive 1 dose level of CBL-514 or 
placebo. The dose of CBL-514 used in Stage 2 will be set no higher than the highest safe dose 
from Stage 1. Each subject will receive up to 4 courses of allocated CBL-514 dose or placebo 
administered in 2.4 mL injections on abdomen, once every 4 weeks. Subject will receive up to 
600 mg dose per treatment with a minimum dose of 300 mg. 
The minimum dose of 300 mg with 25 injections must be administered. It is at the discretion of 
the Investigator to perform dose adjustment for any dose over the minimum dose administration, 
which will depend on the level of fat accumulation on subject’s abdomen.  
The maximum dosing scheme is presented in Table 8 
Table 8: 
Maximum Dosing Scheme-Stage 2 
Group 
CBL-514 
Dose Level 
(mg/cm2) 
Injection 
volume per 
injection in 
6.0 cm2 grid 
space 
Administration for one dose 
No. of 
Injection 
Total Injection 
Volume of IP 
(mL) 
Total CBL-514 (mg) 
CBL-514 
2.0 
2.4 mL 
50 
120 
600 
 
 
Placebo 
- 
2.4 mL 
50 
120 
- 
- 
 


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10.4. 
Method of Assigning Participants to Treatment 
10.4.1. 
Randomization 
Sponsor or designee will manage the randomization of eligible study participants in the study. 
The randomization schedule will be generated before the start of dosing. 
Each subject will be provided with a unique screening number post-documentation of informed 
consent. Subjects who withdraw from the study, for any reason, without completing all necessary 
screening assessments will be considered screen failures (see Section 9.4). 
Stage 1 of the study will be open label with a total 24 subjects sequentially enrolled in 4 dose 
groups (6 subjects in each group) to receive one course of allocated CBL-514 dose as presented 
in Table 7. Once deemed eligible for enrolment in the study, each subject will be assigned a 
sequential subject number prior to first dosing. 
Stage 2 of the study will be a randomized, single-blind, parallel-group. Considering drop-out 
rates (16% CBL-514 group vs 44% placebo group), approximately 75 subjects are planned to be 
enrolled and randomized 2:1 (50 subjects in the CBL-514 group and 25 subjects in the placebo 
group) in order to have a total of at least 56 evaluable subjects in Stage 2 of the study. The dose 
of CBL-514 used in Stage 2 will be set no higher than the highest safe dose from Stage 1. Once 
deemed eligible for enrolment in the study, each subject will be assigned a sequential 
randomization number prior to first dosing. 
10.5. 
Concomitant Medications 
All medications*, including OTC medications, and dietary supplements, taken during the 
6 months prior to Screening visit will be recorded and reviewed by the Investigator to determine 
whether the subject is suitable for inclusion in the study. 
The use of any other IP or investigational medical device within 4 weeks prior to Screening is 
prohibited. Additional restrictions relating to prior and concomitant medication use are outlined 
in Section 9.2 and Section 9.3, respectively. 
All medications*, including OTC medications, and dietary supplements, taken by subjects during 
the course of the study will be recorded in the eCRF and coded using the most current World 
Health Organization (WHO) drug dictionary available at 
 Prior and concomitant 
medications will be listed by subject and summarized by anatomical therapeutic chemical (ATC) 
and PT. 
*Medications to be reported in the eCRF are concomitant prescription medications, OTC 
medications, and non-prescription medications. For this protocol, a prescription medication is 
defined as a medication that can be prescribed only by a properly authorized/licensed clinician. 
A dietary supplement is a product intended for ingestion that contains a “dietary ingredient” 
intended to add further nutritional value to the diet. A “dietary ingredient” may be one, or any 
combination, of the substances containing vitamins, minerals, amino acids, or botanical 
concentrates for use by people to supplement the diet by increasing the total dietary intake. 


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10.6. 
Treatment Compliance 
Study treatments (CBL-514 or placebo) will be administered at the study site by the designated 
study staff under guidance of Investigator or designee. 
If a subject’s study treatment administration and site-related procedures are not conducted as 
defined in the protocol, the Investigator must make note of ensuring compliance to the protocol 
for future activities. The date and time of each study treatment administration and accompanying 
activity will be recorded in the eCRF. 
10.7. 
Blinding 
Stage 2 of this study will be conducted in a single-blind manner where the subjects are blinded to 
treatment but the Investigator, site staff, and the Sponsor, including the Medical Monitor, will be 
unblinded to treatment assignment to assess safety on an ongoing basis. 
Methods of blinding 
• Due to the difference in appearance of the placebo and CBL-514, to keep the study single 
blind, the study needs to create visual barriers to blind subjects. Blinding for subjects will 
be maintained by physical barrier “sheet” placed over the chest obstructing the subjects 
own view of their abdomen, using a blindfold/sunglasses to cover subjects’ eyes while 
administration takes place. 
If during the study the blind is broken for any reason: 
• The reason for unblinding is to be documented in the subject’s source documents and 
case report forms (CRFs). Subjects that were unblinded for any reason during their 
participation in the study will not be replaced. 
• As soon as possible, and without revealing the subject’s study treatment assignment 
(unless important to the safety of participants remaining in the study), the Investigator 
must notify the Sponsor about unblinding and the reason for unblinding. 


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11. 
STUDY DRUG MATERIALS AND MANAGEMENT 
11.1. 
Study Drug 
The Sponsor will supply the IP to the investigational site. The IP provided for this study is 
manufactured under GMP and will be suitable for human use. 
11.2. 
Study Drug Packaging and Labelling 
The Sponsor is responsible for the preparation and labelling and providing details of batch 
numbers, safety and stability data. 
The IP will be labelled in accordance with local regulatory requirements and will be shipped at a 
temperature of 2°C to 8°C. 
11.3. 
Study Drug Storage 
Upon receipt, the IP must be stored at 4°C (39°F). Excursions are permitted between 2°C and 
8°C. Appropriate storage conditions must be ensured either by controlled room temperature, or 
by completing a temperature log in accordance with local requirements on a regular basis (e.g., 
every 30 minutes), showing minimum and maximum temperatures reached over the time 
interval. In case an out-of-range temperature is noted, the variance must be immediately 
communicated to the Clinical Project Manager (or designee) and the Sponsor, before further use 
of the IP. The Clinical Project Manager (or designee) will transmit the out-of-range temperature 
(copy of the temperature log, duration of the out-of-range temperature, if available) to the 
Sponsor. Based on reassurance from the Quality Assurance Department, the Sponsor will 
provide the Clinical Project Manager (or designee) with instructions for the study center 
regarding use of the IP. 
The Investigator or designee will be fully responsible for the security, accessibility, and storage 
of the IP while it is at the investigational facility. 
11.4. 
Study Drug Preparation 
CBL-514 is supplied as a ready-to-use solution. Each vial will contain an appropriate volume of 
CBL-514 with some surplus. Before administration to subjects, the vials should be warmed up to 
room temperature. The solution of CBL-514 should be used for injection lipolysis before expiry 
date. 
Procedures relating to IP preparation and dispensing are outlined in the Pharmacy Manual. 
11.5. 
Administration 
To determine the treatment area, Investigators have to determine the location of the Reference 
point first at the Screening visit. 
 
 
 
 
 


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The Investigator or designee is responsible for the education of study staff as to the correct 
administration of the IP. 
Details relating to IP administration are outlined in the Study Drug Administration Manual. 
11.6. 
Study Drug Accountability 
A record will be maintained by the investigational site that will account for all dispensing and 
return of any used and unused IP and placebo. At the end of the study, the IP and placebo will be 
reconciled, and a copy of the record given to the study monitor. 
11.7. 
Study Drug Handling and Disposal 
On completion of the study, any IP remained at the investigational site will be returned to the 
Sponsor or its designee in accordance with the Sponsor’s instruction. If the destruction of IP is 
allowed at site according to the site procedure, any used or unused IP may be destroyed at the 
investigational site upon receipt of written approval from the Sponsor. Evidence of the 
destruction of any IP should be supplied to the study monitor and the Sponsor. 


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12. 
STUDY SCHEDULE 
A Schedule of Assessments for Stage 1 and Stage 2 of the study are provided in Table 4 and 
Table 5, respectively. 
Where possible, assessments should be conducted in order of least invasive to most invasive. 
12.1. 
Stage 1 
12.1.1. 
Visit 1: Screening (Day -28 to Day -1) 
Prior to enrolling in the study, and before performance of any procedures, potential subjects will 
attend a screening session at which time they will be provided with full information concerning 
details of the study assessments and procedures. They will also be provided with an ICF. Prior to 
being asked to sign the consent form, subjects will be given time to review study information and 
ask any questions. 
After the consent form is signed, screening assessments will be carried out as follows: 
• 
Review and record subject’s demographic details 
• 
Determine subject’s eligibility based on inclusion/exclusion criteria 
• 
Review and record subject’s demographics, medical history and prior medications 
(including a complete history of previous, present, and concomitant conditions and 
treatment/medications within 6 months prior to Screening) 
• 
Collect anthropometric parameters (for Group 1, body height, body weight and thigh 
circumference will be collected; for Group 2-4, body height and body weight will be 
collected) 
• 
Perform abdominal or thigh ultrasound 
• 
Perform medical examinations: 
− Physical examination 
− Vital signs (body temperature, pulse rate, systolic and diastolic BP, and 
respiratory rate) evaluation 
− ECG 
• 
Collect blood/urine to perform laboratory evaluations: 
− Biochemistry panel 
− Hematology panel 
− Coagulation panel 
− Urinalysis 
− Pregnancy test for WOCBP (serum) 
− Virology tests. 


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12.1.2. 
Visit 2: Treatment/Baseline (Day 1) 
12.1.2.1. Before Dosing 
Prior to dosing on Day 1, subjects will be sequentially assigned to respective dose group after 
confirmation of eligibility. 
The following assessments will be carried out prior to the administration of IP unless otherwise 
noted1: 
• 
Determine subject’s eligibility based on inclusion/exclusion criteria 
• 
Collect anthropometric parameters (for Group 1, body weight and thigh 
circumference will be collected; for Group 2-4, only body weight will be collected) 
• 
Perform abdominal or thigh ultrasound. Abdominal or thigh ultrasound may be 
performed up to 4 days before Day 1  
• 
Perform medical examinations: 
− Physical examination 
− Injection site assessment 
− Vital signs (body temperature, pulse rate, systolic and diastolic BP, and 
respiratory rate) evaluation 
− ECG 
• 
Collect blood/urine to perform laboratory evaluations: 
− Biochemistry panel 
− Hematology panel 
− Coagulation panel 
− Urinalysis 
− Pregnancy test for WOCBP (urine) 
• 
Take photographs on the target abdominal or thigh area pre-dose 
• 
Review and record subject’s concomitant medications with the reason for 
administration 
 
 
1 Available measurements of clinical evaluations (physical examinations, vital signs, and ECG) 
and laboratory evaluations (biochemistry, hematology, coagulation, and urinalysis) within 14 
days prior to CBL-514/Placebo dose can be accepted as the Baseline value and will not 
necessitate duplicate examinations. If study drug dose is within 7 days of Screening pregnancy 
test, pregnancy test on Day 1 will not be necessary to assess. 
In cases where more than 1 data is available for a certain evaluation, the latest value prior to the 
study drug administration will be used as the Baseline value. 


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• 
Dispense subject diary to record if there are any changes to the injection site/s or any 
discomforts from Day 1 until last clinic visit or when all ISRs have resolved or 
stabilized. 
• 
Before the administration of the injections,  
− Subjects will take an analgesic (pain killer) as recommended by the Investigator 
− Wipe subject’s abdomen with an antiseptic solution  
− Apply local anesthesia used in local practice to the injection area 
− A cold compress may also be applied before the injection(s) if needed 
 
12.1.2.2. Dosing 
CBL-514 will be administered according to the assigned dose level by assigned clinical staff. 
12.1.2.3. After Dosing 
Subjects will remain at the study site through to the completion of all scheduled post-dose 
procedures. 
The following procedures will be conducted post-dose: 
• 
Apply a cold compress to the treatment area 
• 
Perform medical examinations at the period from 1 hour post-dose to subject leaving 
the site: 
− Injection site assessment 
− Vital signs (body temperature, pulse rate, systolic and diastolic BP, and 
respiratory rate) evaluation 
• 
Take photographs on the target abdominal or thigh area for injection site assessments 
1 hour post-dose. Other timepoints can be added to record the ISR at the discretion of 
the Investigator 
• 
Review and record AEs. 
• 
Pressurize the treatment site with an abdominal binder 
• 
Prescribe analgesic for subjects to bring home as back-up medications 
• 
Provide the Aftercare Procedures and Precautions sheet for subject to bring home. 
12.1.3. 
Visits 3 and 4: Follow-up Period (Week 1/Day 8 [±4 Days] and Week 2/Day 15 
[± 4 Days]) 
Subjects will return to the study site during the follow-up period on Day 8 ± 4 days (Visit 3) and 
Day 15 ± 4 days (Visit 4). 
The following assessments will be carried out on Visit 3 and Visit 4, unless otherwise noted: 


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• 
Review Subject diary 
• 
Collect anthropometric parameters (for Group 1, collect body weight only on Visit 3, 
while collect both body weight and thigh circumference on Visit 4; for Group 2-4, 
collect only body weight on Visit 3 and 4) 
• 
Perform medical examinations: 
− Physical examination2 
− Injection site assessment 
− Vital signs (body temperature, pulse rate, systolic and diastolic BP, and 
respiratory rate) evaluation2 
− ECG2 
• 
Collect blood/urine to perform laboratory evaluations2: 
− Biochemistry panel 
− Hematology panel 
− Coagulation panel 
− Urinalysis 
− Pregnancy test for WOCBP (urine) on Visit 4 only 
• 
Take photographs on the target abdominal or thigh area 
• 
Review and record AEs 
• 
Review and record subject’s concomitant medications with the reason for 
administration. 
12.1.4. 
Visit 5: End of Study Visit (Week 4/Day 29 [±4 Days]) 
Subjects will return to the study site for EOS assessment on Day 29 (±4 days). 
The following assessments will be carried out: 
• 
Collect anthropometric parameters (for Group 1, body weight and thigh 
circumference will be collected; for Group 2-4, only body weight will be collected) 
• 
Perform abdominal or thigh ultrasound. Abdominal or thigh ultrasound may be 
performed up to 4 days before/after Visit 5 
• 
Perform injection site assessment 
• 
Take photographs on the target abdominal or thigh area for injection site assessments 
• 
Review and record AEs 
 
 
2 Assessment/collection can be performed on or within 4-days window prior to visit date. 


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• 
Review and record subject’s concomitant medications with the reason for 
administration, only if a medication is related to AEs following the Visit 4. 
This visit marks the end of participation in this study. 
12.1.5. 
Early Termination (if applicable) 
Subjects who withdraw early from the study will be asked to return to the study site for an EOS 
assessment at ET visit as soon as possible after withdrawal, no later than 6 weeks from the last 
dose received. 
The following procedures will be conducted: 
• 
Review Subject diary 
• 
Collect anthropometric parameters (for Group 1, body weight and thigh 
circumference will be collected; for Group 2-4, only body weight will be collected) 
• 
Abdominal or thigh ultrasound will be performed 
• 
Perform medical examinations: 
− Physical examination 
− Injection site assessment 
− Vital signs (body temperature, pulse rate, systolic and diastolic BP, and 
respiratory rate) evaluation 
− ECG 
• 
Collect blood/urine to perform laboratory evaluations: 
− Biochemistry panel 
− Hematology panel 
− Coagulation panel 
− Urinalysis 
− Pregnancy test for WOCBP (urine) 
• 
Take photographs on the target abdominal or thigh area 
• 
Review and record AEs 
• 
Review and record subject’s concomitant medications with the reason for 
administration. 
This visit marks the end of participation for subjects that withdraw early from the study. 


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12.2. 
Stage 2 
12.2.1. 
Visit 1: Screening (Day -28 to Day -1) 
Prior to enrolling in the study, and before performance of any procedures, potential subjects will 
attend a screening session at which time they will be provided with full information concerning 
details of the study assessments and procedures. They will also be provided with an ICF. Prior to 
being asked to sign the consent form, subjects will be given time to review study information and 
ask any questions. 
After the consent form is signed, screening assessments will be carried out as follows: 
• 
Determine subject’s eligibility based on inclusion/exclusion criteria 
• 
Review and record subject’s demographic details 
• 
Review and record subject’s medical history and prior medications (including a 
complete history of previous, present, and concomitant conditions and 
treatment/medications within 6 months prior to Screening) 
• 
Collect anthropometric parameters (including body height, body weight and 
abdominal skinfold thickness measured by caliper) 
• 
Perform medical examinations: 
− Physical examination 
− Vital signs (body temperature, pulse rate, systolic and diastolic BP, and 
respiratory rate) evaluation 
− ECG 
• 
Collect blood/urine to perform laboratory evaluations: 
− Biochemistry panel 
− Hematology panel 
− Coagulation panel 
− Urinalysis 
− Pregnancy test for WOCBP (serum) 
− Virology tests 
12.2.2. 
Visit 2: Treatment/Baseline (Day 1) 
12.2.2.1. Before Dosing 
Prior to dosing on Day 1, subjects will be randomized to respective groups (i.e., CBL-514 group 
or placebo group) after confirmation of eligibility. 


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The following assessments will be carried out prior to the administration of IP unless otherwise 
noted3: 
• 
Determine subject’s eligibility based on inclusion/exclusion criteria 
• 
Collect anthropometric parameters (including body weight) 
• 
Perform abdominal ultrasound. Abdominal ultrasound may be performed up to 4 days 
before Day 1 
• 
Perform medical examinations: 
− Physical examination4 
− Injection site assessment 
− Vital signs (body temperature, pulse rate, systolic and diastolic BP, and 
respiratory rate) evaluation4 
− ECG4 
• 
Collect blood/urine to perform laboratory evaluations4: 
− Biochemistry panel 
− Hematology panel 
− Coagulation panel 
− Urinalysis 
− Pregnancy test for WOCBP (urine) 
• 
Randomization 
• 
Take photographs on the target abdominal area pre-dose. 
• 
Before the administration of the injections,  
− Subjects will take an analgesic (pain killer) as recommended by the Investigator 
− Wipe subject’s abdomen with an antiseptic solution  
− Apply local anesthesia used in local practice to the injection area 
 
 
3 Available measurements of clinical evaluations (physical examinations, vital signs, and ECG) 
and laboratory evaluations (biochemistry, hematology, coagulation, and urinalysis) within 14 
days prior to CBL-514/Placebo dose can be accepted as the Baseline value and will not 
necessitate duplicate examinations. If study drug dose is within 7 days of Screening pregnancy 
test, pregnancy test on Day 1 will not necessitate be necessary to assess. 
In cases where more than 1 data is available for a certain evaluation, the latest value prior to the 
study drug administration will be used as the Baseline value. 
4 Assessment/collection can be performed on or within 4-days window prior to visit date. 


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− A cold compress may also be applied before the injection(s) if needed 
12.2.2.2. Dosing 
The dose of CBL-514 used in Stage 2 will be set no higher than the highest safe dose from Stage 
1. Subjects will be administered either CBL-514 or the placebo by assigned clinical staff. 
Subjects will be blinded to IP allocation in Stage 2. 
12.2.2.3. After Dosing 
Subjects will remain at the study site through to the completion of all scheduled post-dose 
procedures. 
The following procedures will be conducted post-dose: 
• 
Apply a cold compress to the treatment area 
• 
Take photographs on the target abdominal area for injection site assessments only 
when any severe or unusual ISR was observed and assessed by Investigator after IP 
administration. Other timepoints can be added to record the ISR at the discretion of 
the Investigator 
• 
Review and record AEs 
• 
Review and record subject’s concomitant medications with the reason for 
administration 
• 
Dispense subject diary to record any changes to the injection site/s or any discomforts 
after dosing and between visits. 
• 
Pressurize the treatment site with an abdominal binder 
• 
Prescribe analgesic and anti-histamine for subjects to bring home as back-up 
medications 
• 
Provide the Aftercare Procedures and Precautions sheet for subject to bring home. 
12.2.3. 
Visits 3, 4 and 5 (EOT) Treatment Period (Visit 2+ 4 weeks [+7 Days], Visit 3 + 4 
weeks [+7 Days], and Visit 4+ 4 weeks [+7 Days]) 
12.2.3.1. Before Dosing 
The following assessments will be carried out prior to the administration of IP unless otherwise 
noted: 
• 
Review Subject diary 
• 
Collect anthropometric parameters (including body weight) 
• 
Perform abdominal ultrasound only on Visit 3, 4 and 5. Abdominal ultrasound may 
be performed up to 4 days before the visits  
• 
Perform medical examinations: 


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− Physical examination5 
− Injection site assessment 
− Vital signs (body temperature, pulse rate, systolic and diastolic BP, and 
respiratory rate) evaluation5 
• 
Collect blood/urine to perform laboratory evaluations5: 
− Biochemistry panel 
− Hematology panel 
− Coagulation panel 
− Urinalysis 
− Pregnancy test for WOCBP (urine) 
• 
Take photographs on the target abdominal area pre-dose 
• 
Before the administration of the injections,  
− Subjects will take an analgesic (pain killer) as recommended by the Investigator 
− Wipe subject’s abdomen with an antiseptic solution  
− Apply local anesthesia used in local practice to the injection area 
− A cold compress may also be applied before the injection(s) if needed 
12.2.3.2. Dosing 
CBL-514 will be administered according to the assigned dose group by assigned clinical staff. 
12.2.3.3. After Dosing 
Subjects will remain in the study site through to the completion of all scheduled post-dose 
procedures. 
The following procedures will be conducted post-dose: 
• 
Apply a cold compress to the treatment area 
• 
Take photographs on the target abdominal area for injection site assessments only 
when any severe or unusual ISR was observed and assessed by the Investigator after 
IP administration. Other timepoints can be added to record the ISR at the discretion of 
the Investigator 
• 
Review and record AEs 
 
 
5 Assessment/collection can be performed on or within 4-days window prior to visit date. 


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• 
Review and record subject’s concomitant medications with the reason for 
administration 
• 
Dispense subject diary to record any changes to the injection site/s or any discomforts 
after dosing and between visits. 
• 
Pressurize the treatment site with an abdominal binder 
• 
Prescribe analgesic and anti-histamine for subjects to bring home as back-up 
medications 
• 
Provide the Aftercare Procedures and Precautions sheet for subject to bring home. 
12.2.4. 
Visits 6: Follow-up Period (Visit 5+ 4 weeks [±7 Days]) 
Subjects will return to the study site for follow-up period visit 4 weeks after Visit 5 with a visit 
window of ±7 Days. 
The following assessments will be carried out unless otherwise noted: 
• 
Review Subject diary 
• 
Collect anthropometric parameters (including body weight) 
• 
Perform abdominal ultrasound. Abdominal ultrasound may be performed up to 4 days 
before/after Visit 6 
• 
Satisfaction Questionnaire will be dispensed, and subjects should complete the 
Questionnaire at this visit. Site will review and record the Questionnaire 
• 
Perform medical examinations: 
− Physical examination6 
− Injection site assessment 
− Vital signs (body temperature, pulse rate, systolic and diastolic BP, and 
respiratory rate) evaluation6 
− ECG7 
• 
Collect blood/urine to perform laboratory evaluations6: 
− Biochemistry panel 
− Hematology panel 
− Coagulation panel 
− Urinalysis 
 
 
6 Assessment/collection can be performed on or within 4-days window prior to visit date. 
7 ECG assessment can be performed on or within 4 days before or after visit date.  


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− Pregnancy test for WOCBP (urine) 
• 
Take photographs on the target abdominal area  
• 
Review and record AEs 
• 
Review and record subject’s concomitant medications with the reason for 
administration. 
12.2.5. 
Visit 7: End of Study Visit (Visit 5+ 8 weeks [±7 Days]) 
Subjects will return to the study site for an EOS assessment 8 weeks after Visit 5 with a visit 
window of ±7 days. 
The following assessments will be carried out unless otherwise noted: 
• 
Review Subject diary 
• 
Collect anthropometric parameters (including body weight) 
• 
Perform abdominal ultrasound. Abdominal ultrasound may be performed up to 4 days 
before/after Visit 7 
• 
Perform medical examinations: 
− Perform physical examination8 
− Perform injection site assessment 
• 
Take photographs on the target abdominal area 
• 
Review and record AEs 
• 
Review and record subject’s concomitant medications with the reason for 
administration, only if a medication is related to AEs following the Visit 6. 
This visit marks the end of participation in this study. 
12.2.6. 
Early Termination (if applicable) 
Subjects who withdraw early from the study will be asked to return to the study site for an EOS 
assessment at ET visit as soon as possible after withdrawal, no later than 6 weeks from the last 
dose received. 
The following procedures will be conducted: 
• 
Review Subject diary 
• 
Collect anthropometric parameters (including body weight) 
• 
Perform abdominal ultrasound. Abdominal ultrasound may be performed up to 4 days 
before/after ET Visit 
 
 
8 Assessment/collection can be performed on or within 4-days window prior to visit date. 


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• 
Satisfaction Questionnaire will be dispensed, and subjects should complete the 
Questionnaire at this visit. Site will review and record the Questionnaire 
• 
Perform medical examinations: 
− Physical examination9 
− Injection site assessment 
− Vital signs (body temperature, pulse rate, systolic and diastolic BP, and 
respiratory rate) evaluation9 
− ECG10 
• 
Collect blood/urine to perform laboratory evaluations9: 
− Biochemistry panel 
− Hematology panel 
− Coagulation panel 
− Urinalysis 
− Pregnancy test for WOCBP (urine) 
• 
Take photographs on the target abdominal area 
• 
Review and record AEs 
• 
Review and record subject’s concomitant medications with the reason for 
administration. 
This visit marks the end of participation for subjects that withdraw early from the study. 
 
 
9 Assessment/collection can be performed on or within 4-days window prior to visit date. 
10 ECG assessment can be performed on or within 4 days before or after visit date. 


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13. 
EFFICACY ASSESSMENTS 
Relevant efficacy assessments will be performed by the Investigator or designee in both Stage 1 
and Stage 2 of the study, at visits specified in the schedule of events (Table 4 and Table 5, 
respectively). The assessments will be captured in the eCRF. The assessor who performs the 
assessments must be a medically qualified physician trained in the assessments. If possible, each 
subject should have their assessments done by the same assessor throughout the trial. Extra care 
should be taken to ensure that the same assessor performs the Baseline and post-Baseline 
assessments (if applicable), where the study endpoint data are collected. Efficacy Parameters to 
be assessed are: 
13.1. 
Abdominal or Thigh Subcutaneous Fat Thickness 
Abdominal or thigh subcutaneous fat thickness in the targeted area, will be measured by 
ultrasound in both Stage 1 and Stage 2 of the study, at timepoints specified in schedule of 
assessment Table 4 and Table 5, respectively. 
For Stage 2, there will be a total of 4 ultrasound measuring spots within the treatment area 
(where the area must be injected across the visits). The ultrasound measuring spots will be 
identified by using the Reference point and laser assisted measurement to ensure the consistency. 
The subcutaneous fat thickness at the ultrasound measuring point will be measured by ultrasound 
and will take 3 measurements at each measuring point. Instructions regarding the ultrasound 
assessment will be provided in a separate Ultrasound Measurement Guidelines manual. 
13.2. 
Abdominal or Thigh Subcutaneous Fat Volume 
Abdominal or thigh subcutaneous fat volume over the targeted area, will be measured by 
ultrasound in both Stage 1 and Stage 2 of the study, at timepoints specified in schedule of 
assessment Table 4 and Table 5, respectively. 
Instructions regarding the ultrasound assessment will be provided in a separate Ultrasound 
Measurement Guidelines manual. 
13.3. 
The proportion of subjects with a loss of at least 150 mL or 200 mL 
of subcutaneous fat volume 
The proportion of subjects who lose at least 150 mL or 200 mL of subcutaneous fat volume will 
be compared with placebo to evaluate whether the difference is significant, only in Stage 2 of the 
study. The abdominal fat volume will be measured by ultrasound as described in Section 13.2. 
13.4. 
9-point CBL-514 Satisfaction Questionnaire Score 
Subject’s satisfaction, will be assessed on a 9-point Satisfaction Questionnaire, developed by 
Caliway Biopharmaceuticals Australia Pty Ltd, only in Stage 2 of the study at timepoints 
specified in schedule of assessment Table 5. 
The satisfaction questionnaire along with instructions regarding completion will be provided 
separately. 


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14. 
ASSESSMENT OF SAFETY 
14.1. 
Safety Parameters 
Study procedures should be completed as delineated in the Schedule of Assessments (Table 4 
and Table 5). However, if a subject is unable to attend a visit within the specified window, the 
Investigator or designee should discuss appropriate scheduling with the Sponsor’s MM or 
appropriate designee. Any unscheduled procedures required for urgent evaluation of safety 
concerns must take precedence over all routine scheduled procedures 
14.1.1. 
Demographic/Medical History 
Medical history (including prior medications), date of birth, age (calculated), sex, ethnicity, and 
race will be recorded at Screening. 
Medical history and prior medications include a complete history of previous, present, and 
concomitant conditions and treatment/medications within 6 months prior to Screening. 
14.1.2. 
Vital Signs 
Vital signs will be measured at the time points specified in the study schedules with subjects 
resting for at least 5 minutes in a supine position. Vital sign assessments include temperature, 
pulse rate, blood pressure, and respiratory rate. When the time of vital signs measurement 
coincides with a blood draw, the vital signs will be taken before the scheduled blood draw where 
possible, ensuring the blood draw is within the window specified in the protocol. 
Additional vital signs may be performed at other times if deemed necessary. 
14.1.3. 
Anthropometric Parameters 
Anthropometric parameters including body height, body weight, abdominal skinfold thickness 
measured by caliper, and thigh circumference will be recorded at the time points specified in the 
study schedules. Body height (centimeters) and body weight (kilograms) will be used to calculate 
BMI. BMI is calculated by dividing the subject’s body weight in kilograms by the subject’s 
height in meters squared (kg/m2). Body weight and height will be obtained with the subject’s 
shoes and jacket or coat removed. 
14.1.4. 
Injection Site Reactions 
An examination of the injection site will be performed at the time points specified in the 
Schedule of Assessments and will include a visual assessment and photography of the skin where 
the IP will be administered as well as the surrounding area. Examination of the injection site and 
recording of ISRs may be conducted by the Investigator or designee, so long as the assessment is 
made consistently. Subject diaries will be provided to the subjects and the subjects will be asked 
to record if there are any changes to the injection site/s or any discomforts in between visits. 
ISRs will be recorded as AEs and severity will be assessed according to the CTCAE, version 5.0; 
please refer Table 9. Severity of AEs related to pain will be assessed by the VAS- Pain Intensity 
Scale; please refer Figure 2. 
All events of ISRs should be monitored until resolution or stabilization. 


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14.1.5. 
Physical Examination 
Complete physical examinations will be performed by a licensed physician at the time points 
specified in the study schedules. 
A complete physical examination will include, at a minimum, assessments of the cardiovascular, 
respiratory, gastrointestinal, and neurological systems. 
Physical examinations may be performed at various unscheduled time points if deemed 
necessary by the Investigator. 
14.1.6. 
Electrocardiogram 
An ECG (including parameters: heart rate, RR interval, PR interval, QT interval, QTc interval, 
and QRS interval) will be taken at the time points delineated in the study schedules. Additional 
ECG monitoring may be performed at other times if deemed necessary. 
ECGs will be performed prior to vital signs with subjects in a supine position. Subjects must be 
in this position for at least 5 minutes before the reading is taken. 
All ECG tracings will be reviewed by the Investigator or designee. 
14.1.7. 
Laboratory Assessments 
Safety laboratory tests (hematology, coagulation, biochemistry, urinalysis [dipstick]) will be 
performed at the time points specified in the study schedules (Table 4 and Table 5). Additional 
clinical laboratory tests may be performed at other times if deemed necessary based on the 
subject’s clinical condition. 
Medically indicated laboratory tests (emergency or unscheduled tests) should be conducted at the 
local laboratory. 
14.1.7.1. Hematology 
Hematology parameters to be tested are: 
• 
Hemoglobin (Hb) 
• 
Hematocrit (Hct) 
• 
Erythrocytes (RBC) 
• 
Platelets (PLAT) 
• 
Leukocytes (white blood cells [WBCs]) with differential (including Eosinophils 
[ESN], Neutrophils [NEUT], Basophils [BASO], Lymphocytes [LYM], and 
Monocytes [MONO]) 
• 
Mean corpuscular volume. 
14.1.7.2. Biochemistry 
Biochemistry parameters to be tested are: 
• 
Urea (U) 


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• 
Creatinine (CREAT) 
• 
TBIL 
• 
Albumin (ALB) 
• 
ALKP (ALP) 
• 
AST 
• 
ALT 
• 
GGT 
• 
Estimated Glomerular Filtration Rate (eGFR) 
• 
Glycated hemoglobin (HbA1c) 
• 
Fasting Blood Sugar (FBS) 
• 
Sodium (NA) 
• 
Potassium (K) 
• 
Chloride (CL) 
• 
Bicarbonate (BICARB) 
• 
Triglyceride 
• 
Total cholesterol 
• 
LDL-C 
• 
HDL-C. 
14.1.7.3. Coagulation 
Coagulation parameters to be tested are: 
• 
International Normalized Ratio (INR) 
• 
Activated Partial Thromboplastin Time (aPTT) 
• 
Prothrombin Time. 
14.1.7.4. Urinalysis 
A urinalysis test (dipstick) will be performed for each subject. If clinically significant 
abnormality is noted for protein, blood, or leukocyte esterase (and at the discretion of the 
Investigator) a microscopic examination of RBC, WBC, bacteria, and casts will be performed. 
14.1.7.5. Viral Serology 
HIV Ag/Ab combo test, HBsAg, HBV surface and core antibody test, and HCV antibody testing 
will be performed at Screening. 


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14.1.7.6. Pregnancy Testing 
All WOCBP will be tested for pregnancy by a serum β-hCG test pregnancy test at Screening 
visit, and by urine β-hCG strip pregnancy testing for all other scheduled visits. Additional tests 
will be performed if a subject reports a risk of being pregnant anytime during the study. 
14.1.7.7. Follicle Stimulating Hormone Testing 
Women not of childbearing potential must be post-menopausal (defined as at least 50 years with 
cessation of regular menstrual periods for at least 12 months). Post-menopausal status will be 
confirmed through testing of FSH levels at Screening. 
14.1.7.8. Photographs 
On Visit 2 (Day 1), Visit 3, Visit 4, and Visit 5, the photography will be performed pre-dose. The 
post-dose photography will be performed only when any severe or unusual ISR was observed 
and assessed by the Investigator after IP administration.  
Instructions regarding the photographs to be taken will be provided in a separate Image 
Procedure manual.  
 
 
 
 
 
 


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14.2. 
Adverse and Serious Adverse Events 
In this study, AEs will be reported for all subjects from the time of consent until the completion 
of the EOS/ET visit. SAEs will be reported for all subjects (enrolled and not enrolled) from the 
time of consent. Adverse events reported from the time of consent to pre-dose on Day 1 will be 
recorded as pre-treatment AEs. Treatment emergent- AEs will be evaluated from the first 
administration of IP until the EOS/ET visit. Adverse events that are deemed related to treatment 
and are ongoing 14 days post EOS/ET visit for non-serious AEs and 60 days post EOS/ET visit 
for serious AEs, the AE outcome will be recorded (e.g. Not Recovered or Recovering) depending 
on the status and entered on the AE eCRF page (see Section 14.2.1.4). 
All spontaneously volunteered and enquired for, as well as observed AEs, will be recorded in the 
subject’s medical records and the eCRF. 
14.2.1. 
Definition of Adverse Events 
An AE is any event, side-effect, or other untoward medical occurrence that occurs in conjunction 
with the use of a medicinal product in humans, whether or not considered to have a causal 
relationship to this treatment. An AE can, therefore, be any unfavorable and unintended sign 
(that could include a clinically significant abnormal laboratory finding), symptom, or disease 
temporally associated with the use of a medicinal product, whether or not considered related to 
the medicinal product. 
Events meeting the definition of an AE include: 
• 
Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition 
• 
New conditions detected or diagnosed after IP administration that occur during the 
reporting periods, even though it may have been present prior to the start of the study 
• 
Signs, symptoms, or the clinical sequelae of a suspected interaction 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either IP or 
concomitant medications (overdose per se will not be reported as an AE/ SAE). 
Events that do not meet the definition of an AE include: 
• 
Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that 
leads to the procedure should be reported as an AE if it meets the criteria of an AE 
• 
Situations where an untoward medical occurrence did not occur (e.g., social and/or 
convenience admission to a hospital) 
• 
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present 
or detected at the start of the study that do not worsen. 
If there is evidence of an AE through report or observation, the Investigator or designee will 
evaluate further and record the following information: 
• 
Time of onset and resolution 
• 
Severity 


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• 
Seriousness 
• 
Causality/relation to IP 
• 
Causality/relation to IP administration procedure 
• 
Action taken regarding IP 
• 
Action taken regarding AE 
• 
Outcome. 
14.2.1.1. Severity of an Adverse Event 
Severity of AEs will be assessed by the Investigator according to the CTCAE, version 5.0; please 
refer Table 9. 
Table 9: 
CTCAE Severity Grade Description 
Grade 1  
Mild 
Asymptomatic or mild symptoms; clinical or 
diagnostic observations only; intervention not 
indicated. 
Grade 2  
Moderate 
Minimal, local or noninvasive intervention indicated, 
limiting age-appropriate instrumental activities of 
daily living*. 
Grade 3  
Severe 
Severe or medically significant but not immediately 
life-threatening. 
Hospitalization or prolongation of hospitalization 
indicated disabling. 
limiting self-care activities of daily living**. 
Note: An experience may be severe but may not be 
serious, (e.g., severe headache). 
Grade 4  
Life-Threatening 
Life-threatening consequences: urgent intervention 
indicated. 
Grade 5  
Fatal 
Death related to AE. 
Note: A semi-colon indicates ‘or’ within the description of the grade. 
*Instrumental activities of daily living refer to preparing meals, shopping for groceries or 
clothes, using the telephone, managing money, etc. 
**Self-care activities of daily living refer to bathing, dressing and undressing, feeding self, 
using the toilet, taking medications, and not bedridden. 
Severity of AEs related to pain will be assessed by the VAS- Pain Intensity Scale; please refer 
Figure 2. 
Figure 2 VAS- Pain Intensity Scale 


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14.2.1.2. Causal Relationship of an Adverse Event 
The Investigator will assess the relationship between IP and the occurrence of each AE. The 
Investigator’s assessment of the relationship of each AE to IP will be recorded in the source 
documents and the eCRF. Alternative causes, such as medical history, concomitant therapy, other 
risk factors, and the temporal relationship of the event to the IP should be considered and 
investigated, if appropriate. The relationship of each AE to IP will be assessed by the Investigator 
according to categories in Table 10. 
Table 10: Criteria for Determination of Adverse Event Relationship to IP 
Unrelated 
The event is definitely not associated with the IP. Other conditions including 
concurrent illness, progression or expression of the disease state, or reaction to a 
concurrent medication explain the reported AE. 
Unlikely 
The clinical event, including laboratory test abnormality, with a temporal 
relationship to IP administration based on PK profile in IB which makes a causal 
relationship improbable, and in which other drugs, chemicals or underlying 
disease provide plausible explanations. 
Possibly Related 
The clinical event, including laboratory test abnormality, with a reasonable time 
sequence to administration of the IP administration based on PK profile in IB, but 
which could also be explained by concurrent disease or other drugs or chemicals. 
Probably Related 
The clinical event, including laboratory test abnormality, with a reasonable time 
sequence to administration of the IP administration based on PK profile in IB, 
unlikely to be attributed to concurrent disease or other drugs or chemicals, and 
which follows a clinically reasonable response on withdrawal. 
Definitely Related 
The clinical event, including laboratory test abnormality, occurring in a plausible 
time relationship to IP administration based on PK profile in IB, and which cannot 
be explained by concurrent disease or other drugs or chemicals. The response to 
withdrawal of the drug should be clinically plausible.  
14.2.1.3. Action Taken with Investigational Products 
Should the Investigator need to alter the administration of the IP from the procedure described in 
the protocol due to the well-being and safety of the subject then the action taken will be recorded 
on the AE eCRF page, as one of the following options: 
• 
Dose Reduced 
• 
Drug Interrupted 
• 
Drug Withdrawn 
• 
Not Applicable 


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• 
Other. 
14.2.1.4. Outcome 
Outcome of an AE will be recorded on the AE eCRF as follows: 
• 
Recovered / Resolved 
• 
Recovering / Resolving 
• 
Recovered / Resolved with Sequelae 
• 
Not Recovered / Not Resolving 
• 
Fatal 
• 
Unknown. 
14.2.2. 
Definition of Adverse Event of Special Interest 
An AESI is any event which may be of medical concern specific to the IP. 
Occurrence of any of the below mentioned AESI should trigger a review by the SRC before 
proceeding with the dose escalation/s (Stage 1) or dosing (Stage 2): 
1. 
Fat atrophy that extends > 2 cm from an injection point or is > 10% of the treated 
area or is associated with tenderness lasting > 24 hours. 
2. 
Pain limiting self-care ADL lasting more than 72 hours after active intervention (e.g. 
analgesic). 
3. 
Skin atrophy that extends beyond area of any erythema or induration or is > 10% of 
the treated area or is associated with tenderness lasting > 24 hours. 
4. 
Any skin hyper or hypopigmentation at the target area and/or the surrounding skin 
lasting for > 4 weeks. 
* The color change reflecting from the bruising color is not included. The color 
changes due to deposition or loss of pigment in epidermal tissue is considered as 
hyper or hypopigmentation. 
5. 
Any skin ulceration at the target area and/or the surrounding skin. 
6. 
Any urticaria at the target area and/or the surrounding skin requiring oral treatment 
lasting for > 72 hours. 
7. 
Telangiectasia at the target area and/or the surrounding skin lasting for > 7 days. 
8. 
Local numbness and/or paresthesia lasting for > 7 days. 
Above mentioned AESIs are to be reported to the sponsors within 24 hours upon noticed by 
Investigator or delegates. 
14.2.3. 
Definition of Serious Adverse Event 
An SAE is an AE occurring during any study phase (i.e. Baseline, treatment, washout, or 
follow-up), and at any dose of the IP, that fulfills one or more of the following: 


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• 
Results in death 
• 
It is immediately life-threatening 
• 
It requires in-subject hospitalization or prolongation of existing hospitalization 
• 
It results in persistent or significant disability or incapacity 
• 
Results in a congenital abnormality or birth defect 
• 
It is an important medical event that may jeopardize the subject or may require 
medical intervention to prevent one of the outcomes listed above. 
Important medical events that may not be one of the above may be considered an SAE by the 
Investigator when, based upon appropriate medical judgment, they are considered clinically 
significant and may jeopardize the subject, or may require medical or surgical intervention to 
prevent one of the outcomes listed above. 
An AE is considered “life-threatening” if, in the opinion of either the Investigator or the Sponsor, 
its occurrence places the subject at immediate risk of death. It does not include an AE that, had it 
occurred in a more severe form, might have caused death. 
Note: Medical and scientific judgement should be exercised in deciding whether and adverse 
event/ reaction should be classified as serious in other situations. 
14.2.4. 
Notification of a Serious Adverse Event 
In order to meet the requirements for expedited reporting of SAEs meeting specific requirements 
to applicable regulatory authorities and institutional ethics committees, all SAEs, must be 
reported to Sponsor or Sponsor’s representative within 24 hours from the time the site 
investigational team first become aware of the event. 
Initially reporting is achieved by completing an SAE report form and email to the Sponsor 
or their representative via the assigned project email address, which will be provided upon 
study setup. 
If completion of an SAE form and emailing is not possible, reporting by telephone to Sponsor or 
their representative is required, and a completed SAE form must be emailed at the first 
opportunity. 
Initial notification of an SAE by telephone to Sponsor must be confirmed in writing 24 hours 
from the time the site investigational team first becomes aware of the event using the SAE report 
form as described above. 
As further information regarding the SAE becomes available, such follow-up information should 
be documented on a new SAE report form, marked as a follow-up report, scanned and emailed to 
the address at the bottom of the report form. 
Withdrawal from the study in the event of an SAE and therapeutic measures taken shall be at the 
discretion of the Investigator. A full explanation for the discontinuation from the study should be 
made in the subject’s medical records and in the eCRF. 


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14.2.5. 
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events and Serious Adverse Events 
Abnormal laboratory findings (e.g. biochemistry, hematology, and urinalysis) or other abnormal 
assessments (e.g. ECG and vital signs) per se are not reported as AEs. However, those abnormal 
findings that are deemed clinically significant by the Investigator and/or delegate or are 
associated with signs and/or symptoms must be recorded as AEs if they meet the definition of an 
AE (and recorded as an SAE if they meet the criteria of being serious) as previously described. 
Clinically significant abnormal laboratory or other abnormal findings that are detected after 
consent or that are present at Baseline and worsen after consent are included as AEs (and SAEs 
if serious). 
The Investigator should exercise medical and scientific judgment in deciding whether an 
abnormal laboratory finding, or other abnormal assessment is clinically significant. To be 
considered clinically significant, the abnormality should be associated with a clinically evident 
sign or symptom or be likely to result in an evident sign or symptom in the near term. A 
clinically significant laboratory abnormality in the absence of clinical symptoms may jeopardize 
the subject and may require intervention to prevent immediate consequences. For example, a 
markedly low serum glucose concentration may not be accompanied by coma or convulsions yet 
be of a magnitude to require glucose administration to prevent such sequelae. 
14.2.6. 
Recording Adverse Events 
Adverse events spontaneously reported by the subject and/or in response to an open question 
from the study personnel or revealed by observation will be recorded in accordance with the 
Investigator’s normal clinical practice and on the AE page of the eCRF during the study at the 
investigational site. 
However, abnormal values that constitute an SAE or lead to discontinuation of administration of 
IP must be reported and recorded as an AE. Information about AEs and SAEs will be collected 
from the time of consent until the end of the study. The AE term should be reported in standard 
medical terminology when possible. For each AE, the Investigator will evaluate and report the 
onset (date and time), resolution (date and time), intensity, causality, action taken, serious 
outcome (if applicable), and whether or not it caused the subject to discontinue the study. AEs 
that occur during the study must be documented in the subject’s medical record, on the AE eCRF 
and on the SAE report form. If an SAE report is completed, pertinent laboratory data should be 
recorded on the SAE form, preferably with Baseline values and copies of laboratory reports. 
In addition, if the abnormal assessment meets the criteria for being serious, the SAE form must 
also be completed. A diagnosis, if known, or clinical signs or symptoms if the diagnosis is 
unknown, rather than the clinically significant laboratory finding or abnormal assessment, should 
be used to complete the AE/SAE page. If no diagnosis is known and clinical signs or symptoms 
are not present, then the abnormal finding should be recorded. 
It is important to distinguish between serious and severe AEs. Severity is a measure of intensity 
whereas seriousness is defined by the criteria under Section 14.2.2. An AE of severe intensity 
may not be considered serious. 


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Should a pregnancy occur, it must be reported and recorded on a Pregnancy Form. Pregnancy is 
not regarded as an AE unless there is a suspicion that IP may have interfered with the 
effectiveness of a contraceptive medication. 
The outcome of all pregnancies (spontaneous miscarriage, elective termination, normal birth or 
congenital abnormality) must be followed up and documented even if the subject was 
discontinued from the study. 
All reports of congenital abnormalities/birth defects are SAEs. Spontaneous miscarriages should 
also be reported and handled as SAEs. Elective abortions without complications should not be 
handled as AEs. 
14.3. 
Follow-up of Adverse Events and Serious Adverse Events 
All AEs and SAEs that are deemed related, possibly related or probably related to the IP must be 
followed until resolution, until the condition stabilizes, until the event is otherwise explained, or 
until the subject dies or is lost to follow-up. The Investigator is responsible for ensuring that 
follow-up includes any supplemental investigations as may be indicated to elucidate as 
completely as practical the nature and/or causality of the AE/SAE. This may include additional 
laboratory tests or investigations or consultation with other health care professionals. 
The Sponsor may request that the Investigator perform or arrange for the conduct of 
supplemental measurements and/or evaluations. If a subject dies during participation in the study 
or during a recognized follow-up period, the Sponsor should be provided with a copy of any post 
mortem findings, including histopathology. 
14.4. 
Pregnancy 
Pregnancy testing should be performed in all WOCBP throughout the study as per the Schedule 
of Assessments (Table 4 and Table 5) and the pregnancy results should be captured in the eCRF. 
All WOCBP will be instructed to contact the Investigator immediately if they suspect they might 
be pregnant (e.g., missed or late menstrual period) at any time during the trial. Male subjects will 
contact the Investigator immediately if they suspect they may have fathered a child during the 
study treatment period. When possible, the partner’s pregnancies should be followed (to term) to 
determine the outcome. 
If a subject becomes pregnant during the clinical trial, the Investigator will report the details on a 
Pregnancy Form to the Sponsor/assigned designee within 24 hours of knowledge of the 
pregnancy. Even though subjects agree to withdraw or terminate the clinical trial, the 
Investigator should follow-up and document the process and results of all the pregnancies. 
If a male subject’s female partner becomes pregnant while enrolled in the trial, a Pregnancy 
Form should be completed and sent expeditiously to Sponsor or their representative, irrespective 
of whether it meets the criteria for expedited reporting. Abortions (spontaneous, accidental, or 
therapeutic) must also be reported to Sponsor or their representative. Congenital anomalies/birth 
defects always meet SAE criteria, and should therefore, be expeditiously reported as an SAE, 
using the previously described process for SAE reporting. A Pregnancy Form should also have 
been previously completed and will need to be updated to reflect the outcome of the pregnancy. 
The Investigator must report any pregnancy (including pregnancy of a male participant’s 


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partner), even if no AE has occurred, on a Pregnancy Report Form within 24 hours of the 
Investigator becoming aware of the pregnancy. 
14.5. 
Dose Limiting Toxicity 
No dose limiting toxicities are anticipated. 
15. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
15.1. 
Study Monitoring 
Before an investigational site can enter a subject into the study, a representative of the Sponsor 
will visit the investigational study site to: 
• 
Determine the adequacy of the facilities 
• 
Discuss with the Investigator(s) and other personnel their responsibilities regarding 
protocol adherence, and the responsibilities of the Sponsor or its representatives. This 
will be documented between the Sponsor and the Investigator. 
The Sponsor or designee will manage and monitor the study to assure them of the adequate 
conduct of the study and to act as the contact with the investigational site. A study monitor will 
be identified and will be responsible for liaison with, and support of, the investigational site. 
The study monitor and regulatory authority inspectors are responsible for contacting and visiting 
the investigative site for the purpose of inspecting the facilities and, upon request, inspecting the 
various records of the study (e.g., eCRFs, essential documentation, and other pertinent data) 
provided that subject confidentiality is respected 
During the study, the monitor will have regular contacts with the investigational site for the 
following: 
• 
Provide information and support to the Investigator(s). 
• 
Confirm that facilities remain acceptable. 
• 
Confirm that the investigational team is adhering to the protocol, that data are being 
accurately recorded in the eCRFs, and that IP accountability checks are being 
performed. 
• 
Perform source data verification. This includes a comparison of the data in the eCRFs 
with the subject’s medical records at the hospital or practice, and other records 
relevant to the study. This will require direct access to all original records for each 
subject (e.g. clinic charts). 
• 
Record and report any protocol deviations not previously sent to the Sponsor. 
• 
Confirm AEs and SAEs have been properly documented on eCRFs. 
• 
Confirm any SAEs have been forwarded to the Sponsor and those SAEs that met 
criteria for reporting have been forwarded to the IRB/IEC. 


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The monitor will be available between visits if the Investigator(s) or other staff needs 
information or advice. 
15.2. 
Data Management 
All data will be recorded in individual source documents. An eCRF will be created by the data 
management group for recording of the required data in the study database. All eCRF 
information is to be filled in by site staff. If an item is not available or is not applicable, this fact 
should be indicated. Blank spaces should not be present unless otherwise directed. 
The study monitor will perform source data verification of data entered into the eCRF and raise 
queries for correction by the site. The data entered into the eCRF will be subject to data 
validation checks for consistency and completeness by the data management group. Data queries 
will then be generated and sent to the investigational site for response before the database is 
locked and released for statistical analysis. 
All eCRFs should be maintained on the system with details of any changes logged accordingly. 
15.3. 
Audits and Inspections 
Authorized representatives of the Sponsor, a regulatory authority, or an IRB/IEC may visit the 
site to perform audits or inspections, including source data verification. The purpose of a 
Sponsor audit or inspection is to systematically and independently examine all study-related 
activities and documents to determine whether these activities were conducted, and data were 
recorded, analyzed, and accurately reported according to the protocol, GCP guidelines of the 
ICH, and any applicable regulatory requirements. The Investigator should contact the Sponsor 
immediately if contacted by a regulatory agency about an inspection. 


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16. 
STATISTICS 
All data will be handled and processed according to the Sponsor’s representative standard 
operating procedure (SOPs), which are written based on the principles of GCP. 
A SAP, containing the detailed planned statistical methods, will be finalized prior to locking of 
the study database for the final analysis and will form the basis for the programming of the 
displays and analyses of the final study data. All statistical calculations will be performed using 
SAS® (SAS Institute Inc., Cary, NC, USA) or similar software. No formal hypothesis testing 
will be performed, and all analyses will be descriptive in nature. 
Statistical methods will be further outlined in the SAP and approved by the Sponsor prior to any 
analysis. Procedures outlined in the SAP will supersede protocol specified statistical methods in 
the event of divergence. 
Results will be analyzed and presented by stage of the study and dose group. 
Descriptive statistics will be used to summarize the safety and efficacy data. No formal 
hypothesis testing is planned, and dose comparisons will be exploratory in nature. No 
adjustments will be made for missing or incomplete data, except for missing efficacy data, which 
may be imputed using multiple imputation. 
The Baseline value is defined as the last available result collected/derived prior to the first 
treatment administration. 
The change from Baseline value is defined as the difference between the result at the 
post-Baseline time point and the Baseline value. 
Descriptive statistics will consist of the number of observations (n), mean, SD, minimum, 
median, and maximum for continuous data. Where applicable, 95% CIs for the mean may be 
presented. 
Categorical data will be summarized using counts and percentages. Unless specifically stated 
otherwise, the denominator for all percentage calculations will be the number of subjects in the 
treatment group for the specific analysis set. Where applicable, 95% CIs (Clopper-Pearson) may 
be presented. 
All collected and derived data will be listed. 
16.1. 
Analysis Populations 
Subject inclusion into each population will be determined prior to the final analysis. 
16.1.1. 
Intent-to-treat Population 
The ITT population will include all enrolled or randomized subjects who received at least one 
course of IP treatment. 
16.1.2. 
Safety Population 
All subjects who receive at least one confirmed dose of IP will be included in the Safety 
population. Subjects will be analyzed according to the treatment they actually receive. The safety 
population will be used for summaries and listings of safety, tolerability, and drug exposure data. 


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16.1.3. 
Per Protocol Population 
Stage 1 
• 
A subset of ITT 
• 
Subjects without any efficacy related major protocol violations 
• 
Subjects who complete the proposed dosing schedule of study drug and complete all follow-
up visits after treatment 
• 
Subjects whose body weight remain stable throughout the study, identified as having body 
weight change < 3% based on Day 1 body weight. 
However, a subject who was discontinued due to an AE, or died before the required exposure 
could be met, will still be included in this population. 
Stage 2 
• 
A subset of ITT 
• 
Subjects without any efficacy related major protocol violations 
• 
Subjects who complete all proposed dosing schedules of study drug and complete 2 follow-
up visits after treatment (including the subject who has dose adjustment judged by the 
Investigator) 
• 
Subjects have all visits of IP administration within 6 weeks 
• 
Subjects whose body weight remain stable throughout the study, identified as having body 
weight change < 2.5 kg compared to last visit and change of body weight < 3 kg compared 
to Day 1 body weight 
• 
Subjects whose Visit 6 is performed 3 to 5 weeks post final treatment 
• 
Subjects whose Visit 7 is performed 7 to 9 weeks post final treatment 
However, a subject who was discontinued due to an AE, or died before the required exposure 
could be met, will still be included in this population. 
16.2. 
Safety and Tolerability 
Safety and Tolerability assessment is the primary objective of Stage 1 of the study and secondary 
objective of Stage 2 of the study. 
All safety assessments, including AEs, laboratory evaluations, vital signs, ECGs, physical 
examination, ISR and other safety assessments, will be analyzed using the Safety population. 
Safety data from Stage 1 will be reviewed during the SRC meeting before commencement of 
Stage 2 of the study. A top-level summary of safety data will be submitted to the relevant 
IEC/IRB for review before proceeding to Stage 2 of the study. 
16.2.1. 
Adverse Event 
Adverse events (AEs) will be coded using the most current version of the Medical Dictionary for 
Regulatory Activities (MedDRA®) available at the start of the study. A by subject AE data 


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listing, including verbatim term, PT, SOC, treatment, severity, and relationship to IP, will be 
provided. The number of subjects experiencing TEAEs and number of individual TEAEs will be 
summarized among treatment groups (or sequences), by SOC and PT. TEAEs will also be 
summarized among treatment groups (or sequences), by severity and by relationship to IP. 
16.2.2. 
Laboratory Evaluations 
Laboratory evaluations (including hematology, biochemistry, coagulation, and urinalysis) will be 
listed and summarized by treatment and protocol specified collection time point. Observed and 
change from Baseline clinical laboratory data will be summarized by treatment at each protocol 
specified collection time point. 
The abnormal urinalysis result (dipstick and microscopy), if applicable, will be listed only. 
16.2.3. 
Vital Signs 
Vital signs (blood pressure [systolic and diastolic], pulse rate, respiratory rate, and oral 
temperature) will be listed and summarized by treatment and protocol specified collection time 
point. Observed and change from Baseline will be summarized by treatment at each protocol 
specified collection time point. 
16.2.4. 
12-Lead Electrocardiograms 
12-lead ECG values will be listed and summarized by treatment by protocol specified collection 
time point. Observed and change from Baseline will be summarized by treatment at each 
protocol specified collection time point. 
16.2.5. 
Other Safety Assessments 
The following assessments will be listed by subject: 
• Medical history 
• Prior and concomitant medications 
• Pregnancy test/FSH test 
• Physical examination 
• Serology. 
16.3. 
Efficacy 
Efficacy will be analyzed in both Stage 1 and Stage 2 of the study. 
16.3.1. 
Stage 1 
Efficacy endpoints to be analyzed in Stage 1 are: 
• 
Reduction of subcutaneous fat thickness as measured by ultrasound compared with 
Baseline 


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• 
Reduction of subcutaneous fat volume over the treated area as measured by 
ultrasound compared with Baseline. 
*Note: no efficacy endpoints will be assessed for Group 1 of Stage 1 study. 
The reduction of subcutaneous fat thickness and subcutaneous fat volume over the treated area 
will be summarized with descriptive statistics. An estimate of the 95% CI for the mean reduction 
in subcutaneous fat thickness and corresponding p-value will also be provided. 
The analysis set for the primary efficacy analysis is the ITT population. The primary analysis 
will be repeated using the PP population, as relevant. Exploratory analyses may be performed to 
assess differences between the dose levels. Full details of all exploratory analyses will be 
provided in the SAP. 
16.3.2. 
Stage 2 
Primary efficacy endpoints to be analyzed in Stage 2 are: 
• 
The proportion of subjects who lose at least 150 mL of subcutaneous fat as measured 
by ultrasound compared with placebo  
Secondary efficacy endpoints to be analyzed in Stage 2 are: 
• 
The proportion of subjects who lose at least 200 mL of subcutaneous fat as measured 
by ultrasound compared with placebo 
• 
Number of treatments required to first occurrence of reducing at least 150 mL of 
subcutaneous fat volume over the treated area as measured by ultrasound in CBL-514 
group 
• 
Reduction of subcutaneous fat volume over the treated area as measured by 
ultrasound compared with placebo 
• 
Reduction of subcutaneous fat volume over the treated area as measured by 
ultrasound compared with Baseline 
For the primary endpoint, the proportion of subjects who lose at least 150 mL of subcutaneous 
fat will be summarized for CBL-514 and placebo, respectively, along with their 95% confidence 
intervals. 
The analysis set for the primary efficacy endpoint is the ITT population. The primary analysis 
will be repeated using the PP population, as relevant. Exploratory analyses may be performed to 
assess differences between the dose levels. 
All analyses will be performed without adjustment for multiple endpoints. 
Full details of all efficacy analyses will be provided in the SAP. 


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17. 
ETHICS 
17.1. 
Ethics Review 
The final study protocol, including the final version of the ICF, must be approved or given a 
favorable opinion in writing by an IRB/IEC as appropriate. The Investigator must submit written 
approval to the Sponsor before they can enroll any subject into the study. 
The Investigator is responsible for informing the IRB/IEC of any amendment to the protocol in 
accordance with local requirements. In addition, the IRB/IEC must approve all advertising used 
to recruit subjects for the study. The protocol must be re-approved by the IRB/IEC upon receipt 
of amendments and annually, as local regulations require. 
The Investigator is also responsible for providing the IRB/IEC with reports of any reportable 
serious adverse drug reactions from any other study conducted with the IP. The Sponsor will 
provide this information to the Investigator. 
Progress reports and notifications of serious adverse drug reactions will be provided to the 
IRB/IEC according to local regulations and guidelines. 
17.2. 
Ethical Conduct of the Study 
The study will be performed in accordance with ethical principles that have their origin in the 
Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects) and 
are consistent with ICH GCP applicable regulatory requirements. 
17.3. 
Written Informed Consent 
The Investigator will ensure that the subject is given full and adequate oral and written 
information about the nature, purpose, possible risk, and benefit of the study. Subjects must also 
be notified that they are free to discontinue from the study at any time without prejudice. The 
subject should be given the opportunity to ask questions and allowed time to consider the 
information provided before voluntarily signing the written ICF. 
The subject’s signed and dated informed consent must be obtained before conducting any study 
procedures. The subjects will be informed of their rights to privacy but will be made aware that 
the study data will be submitted to the Sponsor and possibly to drug regulatory authorities for 
review and evaluation. They will be informed also that the study monitor may inspect their 
medical records to verify the accuracy and completeness of the study records and results. 
The acquisition of informed consent should be documented in the subject’s medical records, as 
required, and the ICF will be signed and personally dated by the subject and by the person who 
conducted the informed consent discussion. 
The Investigator must maintain the original, signed ICF. A copy of the signed ICF must be given 
to the subject or legal representative. The date that informed consent was signed will be recorded 
on the eCRF. 


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17.4. 
Data Protection 
Subjects will be informed that data will be held on file by the Sponsor and that these data may be 
viewed by staff including the study monitor and by external auditors on behalf of the Sponsor 
and appropriate regulatory authorities. Subjects will also be informed that a study report will be 
prepared and may be submitted to regulatory authorities and for publication. However, subjects 
will be identified in such reports only by study identification number, gender, and age. All 
subject data will be held in strict confidence. 
18. 
DATA HANDLING AND RECORDKEEPING 
18.1. 
Inspection of Records 
The Sponsor will be allowed to conduct site visits to the investigation facilities for the purpose of 
monitoring any aspect of the study. The Investigator agrees to allow the monitor to inspect the 
drug storage area, IP stocks, drug accountability records, subject charts and study source 
documents, and other records relative to study conduct. 
18.2. 
Retention of Records 
All source data, clinical records and laboratory data relating to the study will be archived for 
15 years after the completion of the study. All data will be available for retrospective review or 
audit. 
Source documents are original documents, data, and records from which the subject’s eCRF data 
are obtained. These include, but are not limited to: hospital records, clinical and office charts, 
laboratory and pharmacy records, diaries, microfiches, radiographs, angiograms, IP 
accountability logs, and correspondence. 
The Investigator and study staff are responsible for maintaining a comprehensive filing system of 
all study-related (essential) documentation. These include but are not limited to: IRB/IEC 
correspondence, IP accountability logs, and curricula vitae of all personnel participating in the 
study. These files must be suitable for inspection at any time by the Sponsor, monitor, and/or 
applicable regulatory authorities. All essential documentation should be retained by the 
institution for 15 years (as required in Australia). 
No study document should be destroyed without prior written agreement between the Sponsor 
and the Investigator. If the Investigator wishes to assign the study records to another party or 
move them to another location, the Investigator must notify the Sponsor in writing of the new 
responsible person and/or the new location. 
18.3. 
Liability/Indemnity/Insurance 
The Sponsor will ensure sufficient insurance is available to enable it to indemnify and hold the 
Investigator(s) and relevant staff as well as any hospital, institution, ethics committee or the like, 
harmless from any claims for damages for unexpected injuries, including death, that may be 
caused by the IP but only to the extent that the claim is not caused by the fault or negligence of 
the subjects or Investigator(s). 


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19. 
PUBLICATION POLICY 
19.1. 
Publication of Results 
The publication, presentation, or other public disclosure of study results (each, a “Publication”) 
will be accurate and honest, undertaken with integrity and transparency and in accordance with 
the Sponsor’s approval. 
Publication of results will be subjected to fair peer-review. Authorship will be discussed between 
researchers prior to study commencement (or as soon as possible thereafter) and reviewed 
whenever there are changes in participation. 
All conflicts arising through disputes about authorship will be reviewed by the Sponsor. 
Authorship should be consistent with the guidelines described in the Australian Code for 
Responsible Conduct of Research (section on Authorship). 
Acknowledgment will be given to collaborating institutions and hospitals and other individuals 
and organizations providing finance or facilities. Subject confidentiality will be maintained by 
referring to individual subjects by their identifying code used in the trial. Data will not be 
released publicly until the manuscript is accepted for publication. In the case of no publication, 
information will only be released to the public and media in accordance with the Sponsor’s 
approval. 
Study data that have not been published, presented, or otherwise disclosed in accordance with the 
clinical trial agreement shall remain confidential information of the Sponsor, the Investigator 
may not disclose or permit the disclosure of such unpublished data to any third party, nor may 
they disclose or permit the disclosure of any study data to any third party in greater detail than 
the same have been disclosed in any permitted publication, presentation or other disclosure. 
The results summary will be posted to the Australian New Zealand Clinical Trials Registry as 
required by legal agreement, local law or regulation. 
19.2. 
Disclosure and Confidentiality 
By signing this protocol, the Investigator agrees to keep all information provided by the Sponsor 
in strict confidence and to request similar confidentiality from site staff and the local IRB/IEC. 
Study documents provided by the Sponsor (protocols, IBs, eCRFs, etc.) will be stored 
appropriately to ensure their confidentiality. The information provided by the Sponsor to the 
Investigator may not be disclosed to others without direct written authorization from the 
Sponsor, except to the extent necessary to obtain informed consent from subjects who wish to 
participate in the study. 
The Investigator must ensure that the subject’s anonymity is also maintained. Subjects should 
only be identified by their initials and a subject study number on the eCRFs and other source 
documents. Other study-related documents (e.g., signed ICFs) should be kept in strict confidence 
by the Investigator. 


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20. 
QUALITY CONTROL AND QUALITY ASSURANCE 
20.1. 
Compliance with Good Clinical Practice 
To ensure compliance with GCP and all applicable regulatory requirements, the Sponsor may 
conduct a quality assurance audit. Please see Section 15.3 for more details regarding the audit 
process. 
This study will be conducted in compliance with IRB/IEC and ICH GCP Guidelines; Title 21 
Part 56 of the US Code of Federal Regulations (CFR) relating to IRBs/IECs and GCP as 
described in the US FDA CFR (21 CFR § 50, 56, 312; applicable ICH guidelines regarding 
clinical safety data management (E2A, E2B[R3]); and with ICH guidelines regarding scientific 
integrity (E4, E8, E9, and E10). In addition, this study will adhere to all local regulatory 
requirements, and requirements for data protection. 
20.2. 
Archiving and Regulatory Inspection 
All study-related documents and records are to be retained for a minimum of 15 years after trial 
completion. Written agreement from the Sponsor must precede destruction of the same. 
In accordance with ICH GCP, this study may be selected for audit. Inspection of site facilities 
(e.g., pharmacy, medication storage areas, laboratories) and review of study-related records may 
occur by the Sponsor, the Sponsor’s representative(s), or regulatory authority to evaluate the 
study conduct and compliance with the protocol, ICH GCP, and applicable regulatory 
requirements 
21. 
CLINICAL STUDY REPORT 
A clinical study report (CSR) will be prepared with reference to the Tripartite Harmonised ICH 
Guideline: Structure and Content of Clinical Study Reports E3 (November 1995) to include: 
• 
Details of where the study was carried out 
• 
Dates of the start and completion of each period of the study 
• 
Details of the IP and a statement of production will be provided by the Sponsor 
• 
A statement confirming that the applicable IRB/IEC gave written approval for the 
study in accordance with local regulations 
• 
A demographic listing for all subjects 
• 
A list of all AEs according to IP 
• 
Details of any occurrences which may be of significance to the study outcome 
• 
Details of all operations, calculations and transformations performed on the reported 
data 
• 
The SAP and report will be produced by the Sponsor, or their agents, and will be 
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• 
A scientific interpretation of the results 
• 
A description of the study methods used. 
Consideration will be given to any comments on a draft report. The report will incorporate the 
analytical and statistical results and methods produced by the Sponsor or their agents. A final 
report will be prepared to contain all those sections in the draft and a statement of compliance 
covering all the areas of the study conducted at the investigational site and the report, with GCP. 
The report will be issued under the Sponsor’s responsibility. 
Where required by the applicable regulatory requirements, an Investigator signatory will be 
identified for the approval of the CSR. The Investigator will be provided reasonable access to 
statistical tables, figures, and relevant reports, and will have the opportunity to review complete 
study results. The Sponsor will also provide the Investigator with the full summary of study 
results. 
22. 
SPONSOR AND INVESTIGATOR OBLIGATIONS 
22.1. 
Protocol Amendments 
Neither the Investigator nor the Sponsor will modify or alter this protocol without the agreement 
of the other. All agreed protocol amendments will be clearly recorded on a protocol amendment 
form and will be signed and dated by the original protocol approving signatories. All protocol 
amendments will be submitted to the relevant institutional IRB/IEC for approval before 
implementation, as required by local regulations. The only exception will be when the 
amendment is necessary to eliminate an immediate hazard to the trial subjects. In this case, the 
necessary action will be taken first, with the relevant protocol amendment following shortly 
thereafter. 
22.2. 
Protocol Deviations 
Should any protocol deviation occur, it must be reported to the study monitor as soon as is 
reasonably practical. The deviation and the reason for its occurrence must be documented, 
reported to the relevant IRB/IEC (if required) and included in the CSR. 


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23. 
LIST OF REFERENCES 
1. Adatto MA, Adatto-Neilson RM, Morren G. Reduction in adipose tissue volume using a 
new high-power radiofrequency technology combined with infrared light and mechanical 
manipulation for body contouring. Lasers Med Sci. 2014;29(5):1627-1631. 
2. American Society of Aesthetic Plastic Surgery. Cosmetic Surgery National Data Bank 
Statistics 2019. Available from: https://www.surgery.org/sites/default/files/Aesthetic-
Society_Stats2019Book_FINAL.pdf. Accessed 16 July 2020. 
3. Atiyeh BS, Ibrahim AE, Dibo SA. Cosmetic mesotherapy: between scientific evidence, 
science fiction, and lucrative business. Aesthetic Plast Surg. 2008;32(6):842-849. 
4. Duncan D, Rotunda AM. Injectable therapies for localized fat loss: state of the art. Clin 
Plast Surg. 2011;38(3):489-vii. 
5. Friedmann DP. A review of the aesthetic treatment of abdominal subcutaneous adipose 
tissue: background, implications, and therapeutic options. Dermatologic Surgery : 
Official Publication for American Society for Dermatologic Surgery [et al.]. 2015 
Jan;41(1):18-34. 
6. Grazer FM, de Jong RH. Fatal outcomes from liposuction: census survey of cosmetic 
surgeons. Plast Reconstr Surg. 2000;105(1):436-448. 
7. Jalian HR, Avram MM. Body contouring: the skinny on noninvasive fat removal. Semin 
Cutan Med Surg. 2012;31(2):121-125. 
8. Kennedy J, Verne S, Griffith R, Falto-Aizpurua L, Nouri K. Non-invasive subcutaneous 
fat reduction: a review. J Eur Acad Dermatol Venereol. 2015;29(9):1679-1688. 
9. Nestor MS, Newburger J, Zarraga MB. Body contouring using 635-nm low level laser 
therapy. Semin Cutan Med Surg. 2013;32(1):35-40. 
10. Nürnberger F, Müller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol. 
1978;4(3):221-229. 
11. Rotunda AM, Kolodney MS. Mesotherapy and phosphatidylcholine injections: historical 
clarification and review. Dermatol Surg. 2006;32(4):465-480. 
 
 


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24. 
APPENDIX  
24.1. 
Appendix I: Reference List of Prohibited Substances (CYP inhibitors and 
inducers only) 
The following table (not exhaustive) provides a list of drugs, herbal products and foods that are 
CYP inhibitors or inducers for reference only. Any questions or concerns should be referred to 
the Sponsor or Investigator for review. 
 
CYP3A4 
Inhibitors 
Drugs 
amprenavir, aprepitant, atazanavir, boceprevir, ciprofloxacin, 
clarithromycin, cobicistat, conivaptan, crizotinib, cyclosporine, 
danoprevir, darunavir, diltiazem, dronedarone, elvitegravir, 
erythromycin, faldaprevir, fluconazole, idelalisib, imatinib, indinavir, 
isavuconazole, itraconazole, ketoconazole, mibefradil, nefazodone, 
nelfinavir, netupitant, nilotinib, posaconazole, ribociclib, ritonavir, 
saquinavir, telaprevir, telithromycin, tofisopam, troleandomycin, 
verapamil, voriconazole 
Herbals 
and 
Foods 
grapefruit juice, Schisandra sphenanthera extract 
CYP3A4 
Inducers 
 
 
Drugs 
bosentan, carbamazepine, dabrafenib, efavirenz, enzalutamide, 
etravirine, genistein, lopinavir, lumacaftor, mitotane, modafinil, 
nafcillin, phenobarbital, phenytoin, rifabutin, rifampicin[rifampin], 
telotristat, thoridazine 
Herbals 
and 
Foods 
St. John's wort 
CYP2D6 
Inhibitors 
Drugs 
• Amiodarone 
• Celecoxib 
• Chloroquine 
• Chlorpromazine 
• Cimetidine 
• Citalopram 
• Clomipramine 
• Codeine 
• Delavirdine 
• Desipramine 
• Dextropropoxyphene 
• Diltiazem 
• Doxorubicin 
• Entacapone (high dose) 
• Fluoxetine 
• Fluphenazine 
• Fluvaxamine 
• Haloperidol 
• Labetalol 
• Lobeline 


Caliway Biopharmaceuticals Australia Pty Ltd 
CBL-0202 Protocol 
CBL-514 
Version 8.0 Dated 01-Mar-2023 
 
 
 
CONFIDENTIAL  
Page 104 
 
• Lomustine 
• Methadone 
• Mibefradil 
• Moclobemide 
• Nortuloxeline 
• Paroxetine 
• Perphenazine 
• Propafenone 
• Quinacrine 
• Quinidine 
• Ranitidine (ranitidine, Zantac) 
• Risperidone (weak) 
• Ritonavir 
• Serindole 
• Sertraline (weak) 
• Thioridazine 
• Valproic acid 
• Venlafaxine (weak) 
• Vinblastine 
• Vincristine 
• Vinorelbine 
• Yohimbine 
CYP2D6  
inducer 
Dexamethasone 
• Rifampin 
 
Prohibited substances (CYP inhibitors and inducers only) compiled from multiple sources, 
including: 
1. 
FDA DDI Index Inhibitors and Inducers (https://www.fda.gov/drugs/drug-interactions-
labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers) 
2. 
Flockhart Table at Indiana University (https://drug-interactions.medicine.iu.edu/Home.aspx) 
3. 
UW DIDB (https://www.druginteractionsolutions.org/solutions/drug-interaction-database/) 
4. 
Prescriber’s Information for FDA approved products 
 

SAP_003.pdf: 
Protocol Number: CBL-0202 
 
2023-09-19 
Document status:  Addendum 1.0 
 - Strictly Confidential 
Page 1 of 50 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
A 2-Stage Adaptive Design, Phase 2 Study to Evaluate the Efficacy, Safety and 
Tolerability of CBL-514 Injection for Reducing Abdominal and Thigh Subcutaneous Fat 
 
PROTOCOL NO.: 
CBL-0202 
 
PRODUCT CODE:   CBL-514 
 
PREPARED FOR: 
Caliway Biopharmaceuticals Australia Pty Ltd 
 
58 Gipps Street, 
 
Collingwood, VIC, 3066 
 
Australia 
 
PREPARED BY: 
 
 
 
 
 
  
 
  
 
DATE OF ISSUE: 
2023-09-19 
 
 
VERSION/STATUS: 
 Addendum 1.0 
 
 
VERSION HISTORY: Version 0.1/ Draft (2023-01-16) 
                                      Version 0.2/ Draft (2023-02-01) 
                                          Version 0.3/ Draft (2023-03-30)  
                                      Version 1.0/ Final (2023-06-20) 
 
 
 
 
AUTHOR: 
 
 
The information in this document is confidential and proprietary to 
 and its 
clients. The information may only be used by the entities to which it was disclosed for the 
purpose it was disclosed. To the maximum extent permissible by law, the information must not 
be disclosed to any third parties without the prior written consent of 
 
 
 


Protocol Number: CBL-0202 
 
2023-09-19 
Document status:  Addendum 1.0 
 
 - Strictly Confidential 
Page 2 of 50 
 
Document History Changes made from SAP V1.0 in Addendum 1.0 
 
1. 
Changes in SAP text:  The following changes are made from final approved SAP: 
Reference to Imputation methods and outputs from Section 10 are removed: Efficacy and 
other sections of SAP wherever imputation method is given. 
Justification of change from final SAP: 
It was not realized until later that the definition of missing data between Caliway and 
 is different. Per study design, there are visits can be skipped or no need to be 
completed. From Caliway’s perspective, only visit that should be completed per protocol but 
not completed can be deemed as missing. But from 
 perspective, all visits not 
completed will be deemed as missing regardless of the missing reason. Therefore, Caliway 
decided to remove imputation from the SAP at this time point as it does not work the way 
Caliway originally thought it will be.  
 
2. 
Changes in Mock shell: TFLs with imputations are removed. 
  
 


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Page 3 of 50 
SAP APPROVAL 
 
By my signature, I confirm that changes  from  SAP V1.0  in   Addendum 1.0 has been reviewed by 
Caliway Biopharmaceuticals Australia Pty Ltd and has been approved for use on the CBL-0202 study: 
 
Name 
Title / Company 
Signature 
Date 
 
Senior 
Clinical 
Project 
Specialist/ 
Caliway Biopharmaceuticals Australia Pty 
Ltd 
 
 
 
 
 
 
 
 
By my signature, I confirm that changes from SAP V1.0 in Addendum 1.0 has been reviewed by 
 and has been approved for use on the CBL-0202 study: 
 
Name 
Title / Company 
Signature 
Date 
Prepared by: 
 
Senior Biostatistician / 
 
 
 
Reviewed by: 
 
 
Senior Biostatistician/ 
 
 
 
 


Protocol Number: CBL-0202 
 
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Document status:  Addendum 1.0 
 
 - Strictly Confidential 
Page 4 of 50 
Table of contents 
 
1. 
INTRODUCTION 
7 
2. 
PROJECT OVERVIEW 
8 
2.1 
Study Design 
8 
2.2 
Objectives 
12 
2.3 
Endpoints 
13 
2.4 
Sample Size 
13 
2.5 
Randomization 
14 
3. 
STATISTICAL CONSIDERATIONS 
15 
3.1 
General Considerations 
15 
3.2 
Key Definitions 
15 
3.3 
Multiple Comparisons and Multiplicity Adjustments. 
17 
3.4 
Handling of Missing Data 
17 
3.5 
Coding of Events and Medications 
18 
3.6 
Treatment Groups 
18 
4. 
ANALYSIS POPULATIONS 
19 
4.1 
Population Descriptions 
19 
5. 
PARTICIPANT DISPOSITION AND ANALYSIS POPULATIONS 
21 
6. 
PROTOCOL DEVIATIONS 
22 
7. 
DEMOGRAPHIC AND BASELINE INFORMATION 
23 
7.1 
Demographics 
23 
7.2 
Medical /Surgical history 
23 
7.3 
Viral Serology 
23 
7.4 
Pregnancy 
23 
7.5 
Follicle Stimulating Hormone Testing 
23 
7.6 
Eligibility 
23 
8. 
TREATMENT EXPOSURE 
24 
9. 
PRIOR AND CONCOMITANT MEDICATIONS 
25 
10. 
EFFICACY 
26 
11. 
SAFETY 
29 
11.1 
Adverse Events 
29 
11.2 
Safety Laboratory Assessments 
30 
11.3 
Vital Signs 
32 
11.4 
12-Lead Electrocardiogram (ECG) 
32 
11.5 
Physical Examinations 
33 
11.6 
Pregnancy and Follicle Stimulating Hormone (FSH) Tests 
33 
12. 
IMMUNOGENICITY 
34 


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13. 
CHANGES TO THE PLANNED ANALYSIS 
35 
14. 
INTERIM AND FINAL ANALYSIS 
36 
14.1 
Interim Analysis 
36 
14.2 
Final Analysis (End of Study) 
36 
15. 
SOFTWARE 
37 
16. 
Appeendix 
38 
16.1 
Appendix 1: Schedule of Assessments (Stage 1) 
38 
16.2 
Appendix 2: Schedule of Assessments (Stage 2) 
41 
16.3 
Appendix 3: MMRM Assumptions Testing 
44 
17. 
TABLES AND Listings 
46 
18. 
REFERENCES 
50 


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Page 6 of 50 
List of Abbreviations 
Abbreviation 
Description 
 
 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
APTT 
Activated Partial Thromboplastin Time 
ATC 
Anatomical Therapeutic Class 
CI 
Confidence Interval 
CS 
Clinically Significant 
CSR 
Clinical Study Report 
DBP 
Diastolic blood pressure 
ECG 
12-Lead Electrocardiogram  
eCRF 
Electronic Case Report Form 
eGFR 
Estimated Glomerular Filtration Rate 
ET 
Early Termination 
FBS 
Fasting Blood Sugar 
FSH 
Follicle Stimulating Hormone 
GCP 
Good Clinical Practice 
HDL-C 
High-Density Lipoprotein Cholesterol 
HIV 
Human Immunodeficiency Virus 
INR 
International Normalized Ratio 
IP 
Investigational Product 
ISR 
Injection Site Reaction 
ITT 
Intent-to-Treat 
LDL-C 
Low-Density Lipoprotein Cholesterol 
MAD 
Multiple Ascending Dose 
MedDRA 
Medical Dictionary for Regulatory Activities 
N/A 
Not Applicable 
NCS 
Not Clinically Significant 
NK 
Not Known 
PI 
Principal Investigator 
PT 
Preferred Term 
SAD 
Single Ascending Dose 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SBP 
Systolic blood pressure 
SD 
Standard Deviation 
S.I. 
International System of Units 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SRC 
Safety Review Committee 
TEAE 
Treatment Emergent Adverse Event 
WHO-DD 
World Health Organization Drug Dictionary 
 
 
 
 
 


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1. 
INTRODUCTION 
The following Statistical Analysis Plan (SAP) provides the outline for the statistical analysis of the 
data collected from the CBL-0202 study (protocol version 8.0 dated 1 March 2023). 
The planned analyses identified in this SAP may be included in clinical study reports (CSRs), 
regulatory submissions, or future manuscripts. Also, post hoc exploratory analyses not necessarily 
identified in this SAP may be performed to further examine study data. Any post hoc, or unplanned, 
exploratory analyses performed will be clearly identified as such in the final CSR. 


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Page 8 of 50 
2. 
PROJECT OVERVIEW 
2.1 
Study Design 
This is a 2-stage adaptive design, Phase 2 study to evaluate the efficacy, safety, and tolerability of 
CBL-514 injection for reducing abdominal or thigh subcutaneous fat. This Phase 2 study has an 
integrated design consisting of a SAD part in Stage 1. Stage 2 will be conducted as a single-blind, 
placebo-controlled study, with 1 treatment group and 1 placebo group. A total of approximately 99 
adult subjects with  
- 
thigh subcutaneous fat thickness of at least 1.00 cm (10.0 mm) and up to 4.00 cm (40.0 mm) 
measured by ultrasound at Screening and Day 1, for Group 1 in Stage 1,  
- 
abdominal subcutaneous fat thickness of at least 2.00 cm (20.0 mm) and up to 5.00 cm (50.0 
mm) measured by ultrasound at Screening and Day 1 for Group 2-4 in Stage 1, 
- 
and abdominal skinfold thickness of at least 3.00 cm (30.0 mm) and up to 8.00 cm (80.0 mm) 
by pinch method (measured by calibrated caliper) at Screening for Stage 2, 
will be enrolled across the 2 stages of the study. 
Stage 1 (single dose, open label, dose escalation) 
Stage 1 will include a total of 24 subjects enrolled in 4 sequential escalating CBL-514 dose groups and 
will receive a single course of CBL-514: 320 mg, 480 mg, 640 mg, and 800 mg. The groups will be 
open label. The 4 groups will each include 6 subjects.  
Subjects in Group 1 (320 mg) will receive CBL-514 injections on thighs, with total allocated dose of 
IP evenly divided into 2 thighs. Subjects from Group 2 to 4 (480 mg-800 mg) will receive CBL-514 
injections on abdomen with allocated dose of IP. 
Based upon SRC recommendation intermediate doses may be explored. 
The dosing scheme is presented in Table 1. 
 
Table 1: Dosing Scheme-Stage 1 
Group 
Treatment 
area 
CBL-514 
Dose 
Level 
(mg/cm2) 
Injection 
volume per 
injection in 
4 cm2 grid 
space 
Administration for one dose 
No. 
of 
Injection 
Total Injection 
Volume 
of 
CBL-514* 
(mL) 
Total CBL-514 (mg) 
1 
Thighs 
2.0 
1.6 mL 
40 / 20  
(total/ 
per 
thigh) 
64 / 32 
(total/ per thigh) 
320 
 
 
2 
Abdomen 
2.0 
1.6 mL 
60 
96 
480 
 
 
3 
Abdomen 
2.0 
1.6 mL 
80 
128 
640 
 
 
4 
Abdomen 
2.0 
1.6 mL 
100 
160 
800 
 
 
*The concentration of CBL-514 is 5 mg/mL 
A schematic of the study design is provided in Figure 1. Local effects of CBL-514 injection will be 
evaluated, and blood samples will be taken and analyzed to assess the safety of IP. 


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Subjects will be screened for inclusion and exclusion criteria during a 28-day screening period (Day -
28 to Day -1). At the Treatment visit (Day 1), eligible subjects will be sequentially assigned to receive 
1 course of allocated CBL-514 dose. 
Subjects will visit the site on each of the study visits. Subjects will remain onsite for observation for at 
least 1 hour after the administration of CBL-514, or longer at the discretion of the Investigator and 
until all planned assessments for the visit are completed. 
Subjects who are withdrawn from the study earlier than planned should attend an ET visit as soon as 
possible after early withdrawal, no later than 6 weeks from the last dose received. 
A subject diary will be provided to each subject, to record if there are any changes to the injection 
site/s or any discomforts from Day 1 until last clinic visit or when all ISRs have resolved or stabilized. 
Subjects will be instructed to bring the subject diary with them for all visits to the clinic. 
During Stage 1 of the study, the SRC will meet after all subjects in a dose group have completed the 
Week 1 visit. The SRC will review all reported AEs, AESIs, laboratory trends, and vital signs of all 
subjects from each dose group. Based upon review of available safety and tolerability data from each 
preceding dose group, the SRC will make a decision on progressing to the next dose group. 
The safety and tolerability data of CBL-514 from Stage 1 will be reviewed by the SRC before 
commencement of Stage 2. A top-level summary of safety data will be submitted to the relevant 
IRB/IEC for review before proceeding to Stage 2 of the study. 
Study visits and assessments for Stage 1 of the study will occur as delineated in the Schedule of 
Assessments. 
Stage 2 (multiple-dose, randomized, single-blind, parallel, placebo-controlled study) 
Stage 2 will be conducted as a single-blind study, with 1 CBL-514 group and 1 placebo group. Each 
subject will receive up to 4 treatments of allocated CBL-514 (2 mg/cm²) or placebo administered on 
abdomen, once every 4 weeks. The minimum dose is 300 mg per treatment and the maximum dose is 
600 mg per treatment. The dose adjustment will depend on the level of fat accumulation on subject’s 
abdomen at the discretion of the Investigator. 
Stage 2 of the study will be initiated after IRB/EC review of top-level summary of safety data from 
Stage 1 of the study. The dose for Stage 2 will be based on a review of the safety data from Stage 1 of 
the study and the dose for Stage 2 will be set no higher than the highest safe dose from Stage 1. 
In Stage 2, subjects will be randomized 2:1 CBL-514 group vs placebo group. Considering drop-out 
rates, approximately 75 subjects will be enrolled (50 subjects in the CBL-514 group and 25 subjects in 
the placebo group) in order to have 56 evaluable subjects for the 2 groups. 
Subjects should have sufficient subcutaneous fat on their abdomen to receive injections on Day 1. This 
will be based on eligibility criteria set out in inclusion criterion 3 mentioned in the study protocol. 
Before administration, the Investigator should evaluate whether a subject is able to receive the 
minimum dose, 300 mg (25 injections) as defined by Study Drug Administration Manual. 
 
 If a subject is not able to receive the minimum 
injection dose, the ongoing treatment and post-dose assessments will be cancelled, and the remaining 
treatment visits would not be required for that subject. For subjects that do not complete 4 treatments 
due to not enough residual fat, the subject will be requested to continue with follow-up visits (Visit 6 
and 7). This arrangement would not be regarded as missing protocol required visits, or as 
discontinuation from the study. 
If a subject cannot complete the 4 treatments and withdraws from the study because of reasons except 
for dose adjustment, only the ET visit should be performed for final follow-up. 


Protocol Number: CBL-0202 
 
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Page 10 of 50 
Subjects will be screened for inclusion and exclusion criteria during a 28-day screening period (Day -
28 to Day -1). At Visit 2 (Day 1), eligible subjects will be randomized 2:1: (i.e., CBL-514 group: 50 
subjects; placebo group: 25 subjects) to receive CBL-514 or placebo, respectively.  
Subjects will visit the site on each of the study visits and will remain onsite for observation for 1 hour 
after the administration of the IP, or shorter/ longer at the discretion of the Investigator and until all 
planned assessments for the visit are completed. 
An ET visit has been planned for subjects who are withdrawn from the study earlier than planned for 
assessment as soon as possible after early withdrawal, no later than 6 weeks from the last dose received. 
A subject diary will be provided to each subject to record if there are any changes to the injection site/s 
or any discomforts in between visits. Subjects will be instructed to bring the subject diary with them 
for all visits to the clinic. 
 
Table 2: Maximum Dosing Scheme-Stage 2 
Group 
CBL-514 
Dose Level 
(mg/cm2) 
Injection 
volume per 
injection in 
6.0 cm2 grid 
space 
Administration for one dose 
No. 
of 
Injection 
Total Injection 
Volume of IP 
(mL) 
Total CBL-514 (mg) 
CBL-514 
2.0 
2.4 mL 
50 
120 
600 
 
 
Placebo 
- 
2.4 mL 
50 
120 
- 
- 
 
 
 


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Page 11 of 50 
Figure 1: 
Study Design 
 
Stage 1 
 
 
 
Stage 2 
 
 
 


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2.2 
Objectives 
2.2.1 
Primary objectives 
Stage 1: 
The primary objective of Stage 1 the study is to: 
• 
Evaluate the safety and tolerability of injection lipolysis with CBL-514 
 
Stage 2: 
The primary objective of Stage 2 of the study is to: 
• 
Assess the proportion of subjects who lose at least 150mL of subcutaneous fat volume over the 
treated area as measured by ultrasound compared with placebo. 
 
2.2.2 
Secondary objectives 
Stage 1: 
The secondary objective of Stage 1 of the study is to: 
• 
Assess the efficacy of single course of CBL-514 at applicable dose levels in reducing 
subcutaneous fat over the treated area as measured by ultrasound compared with Baseline. 
 
*Note: no efficacy endpoints/objectives will be assessed for Group 1 of Stage 1 study. 
 
Stage 2: 
The secondary objectives of Stage 2 of the study are to: 
• 
Assess the proportion of subjects who lose at least 200 mL of subcutaneous fat volume as 
measured by ultrasound compared with placebo 
• 
Evaluate the number of treatments required to first occurrence of reducing at least 150 mL of 
subcutaneous fat volume over the treated area as measured by ultrasound in CBL-514 group. 
• 
Assess the efficacy of up to 4 courses of CBL-514 in reducing subcutaneous fat volume over 
the treated area as measured by ultrasound compared with placebo 
• 
Assess the efficacy of up to 4 courses of CBL-514 in reducing subcutaneous fat volume over 
the treated area as measured by ultrasound compared with Baseline 
• 
Evaluate safety following up to 4 courses of CBL-514 when compared with placebo 
 
 


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2.3 
Endpoints 
2.3.1 
Primary endpoints 
Stage 1: 
• 
Safety and tolerability following single dose of CBL-514 as assessed by recording of TEAEs, 
laboratory assessments, vital signs, ECGs, physical examinations, and injection site assessment. 
Stage 2: 
• 
The proportion of subjects who lose at least 150 mL of subcutaneous fat as measured by 
ultrasound from Baseline to follow-up visits compared with placebo. [Time frame: Visit 2 
(Baseline), Visit 6, and Visit 7] 
2.3.2 
Secondary endpoints(s) 
Stage 1: 
• 
Reduction of subcutaneous fat thickness as measured by ultrasound compared with Baseline. 
[Time frame: Day 1 and Week 4] 
• 
Reduction of subcutaneous fat volume over the treated area as measured by ultrasound 
compared with Baseline. [Time frame: Day 1 and Week 4] 
*Note: no efficacy endpoints/objectives will be assessed for Group 1 of Stage 1 study. 
 
Stage 2: 
• 
Reduction of subcutaneous fat volume over the treated area as measured by ultrasound from 
Baseline to follow-up visits compared with placebo. [Time frame: Visit 2 (Baseline), Visit 6, 
and Visit 7] 
• 
Reduction of subcutaneous fat volume over the treated area of the CBL-514 group as measured 
by ultrasound compared with individual Baseline. [Time frame: Visit 2 (Baseline), Visit 3, Visit 
4, Visit 5, Visit 6, and Visit 7] 
• 
Number of treatments required to first occurrence of reducing at least 150 mL of subcutaneous 
fat volume over the treated area as measured by ultrasound in CBL-514 group. [Time frame: 
from Visit 2 (Baseline) to Visit 7] 
• 
The proportion of subjects who lose at least 200 mL of subcutaneous fat as measured by 
ultrasound from baseline to follow-up visits compared with placebo. [Time frame: Visit 2 
(Baseline), Visit 6, and Visit 7] 
• 
Safety as assessed by recording of TEAEs, laboratory assessments, vital signs, ECGs, physical 
examinations, and ISRs compared with placebo 
2.4 
Sample Size 
Approximately 99 adult male or female subjects, will participate in the study. A total of 24 subjects are 
planned to be enrolled in 4 sequential groups in Stage 1 of the study. Considering drop-out rates, 
approximately 75 subjects are planned to be enrolled and randomized 2:1 (i.e., 50 subjects in the CBL-
514 group and 25 subjects in the placebo group) in order to have 56 evaluable subjects in Stage 2 of 
the study. The sample size for stage 2 of the study was calculated based on currently accepted 
standards for exploratory investigation design. 


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2.5 
Randomization 
Stage 1 of the study will be open label with a total of 24 subjects sequentially enrolled in 4 dose groups 
(6 subjects in each group) to receive one course of allocated CBL-514 dose as presented in Table 1. 
Once deemed eligible for enrolment in the study, each subject will be assigned a sequential subject 
number prior to first dosing. 
Stage 2 of the study will be a randomized, single-blind, parallel-group. Considering drop-out rates 
(16% CBL-514 group vs 44% placebo group), approximately 75 subjects are planned to be enrolled 
and randomized 2:1 (50 subjects in the CBL-514 group and 25 subjects in the placebo group) in order 
to have a total of at least 56 evaluable subjects in Stage 2 of the study. The dose of CBL-514 used in 
Stage 2 will be set no higher than the highest safe dose from Stage 1. Once deemed eligible for 
enrolment in the study, each subject will be assigned a sequential randomization number prior to first 
dosing. 


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3. 
STATISTICAL CONSIDERATIONS 
Data will be handled and processed per the sponsor’s representative 
 Standard Operating 
Procedures (SOPs), which are written based on the principles of good clinical practice (GCP).  
3.1 
General Considerations 
All data collected on the electronic case report form (eCRF) will be presented in the data listings and 
will be listed and sorted by treatment arm participant number and visit, where applicable. All 
descriptive summaries will be presented by treatment group and nominal visit/time point (where 
applicable).  
Unless otherwise stated, the following methods will be applied: 
• 
Continuous variables: Descriptive statistics will include the number of non-missing values (n), 
arithmetic mean, standard deviation (SD), median, minimum and maximum values.  
The minimum and maximum values will be displayed to the same decimal precision as the 
source data, the arithmetic mean, SD and median values will be displayed to one more decimal 
than the source data for the specific variable. 
95% Confidence Intervals (CIs), mean differences (among treatments and from baseline) and 
least-square (LS-Means) values will be displayed to one more decimal than the source data for a 
specific variable. P-values will be displayed to 5 decimal places. 
The appropriate precision for derived variables will be determined based on the precision of the 
data on which the derivations are based, and statistics will be presented in accordance with the 
above mentioned rules. 
• 
Categorical variables: Descriptive statistics will include counts and percentages per category. 
The denominator in all percentage calculations will be the number of participants in the relevant 
analysis population with non-missing data, unless specifically stated otherwise. Percentages will 
be displayed to one decimal place. Proportions will be displayed to 3 decimal places. 
95% Confidence Intervals (CIs), difference in proportions, and other categorical parameters will 
be displayed to one decimal place for percentages. Proportions will be displayed to 3 decimal 
places. P-values will be displayed to 5 decimal places. 
• 
Repeat/unscheduled assessments: Only values collected at scheduled study visits/time points 
will be presented in summary tables. If a repeat assessment was performed, the result from the 
original assessment will be presented as the result at the specific visit/time point. All collected 
data will be included in the data listings. 
• 
Assessment windows: All assessments will be included in the data listings and no visit windows 
will be applied to exclude assessments that were performed outside of the protocol specified 
procedure windows. 
• 
Result display convention: Results will be center aligned in all summary tables and listings. 
Participant identifiers visit and parameter labels may be left-aligned if required. 
• 
Date and time display conventions: The following display conventions will be applied in all 
outputs where dates and/or times are displayed: 
Date only: YYYY-MM-DD 
Date and time: YYYY-MM-DD HH:MM 
If only partial information is available, unknown components of the date or time will be presented as 
‘NK’ (not known), i.e., ‘2016-NK-NK’. Times will be reported in military time. 
3.2 
Key Definitions 
The following definitions will be used: 


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• 
Subcutaneous Fat Thickness: Subcutaneous fat thickness can be calculated by the mean of 
ultrasound results of subcutaneous fat thickness at 4 ultrasound scan spots on abdomen including 
far left, left, far right, and right spots: 
Subcutaneous Fat Thickness = [Ultrasound Result (Far Left) + Ultrasound Result (Left) + 
Ultrasound Result (Right) + Ultrasound Result (Far Right)] / 4 
• 
Subcutaneous Fat Volume:  
- 
Stage 1: Subcutaneous fat volume over treated area for each treatment group in Stage 1 
will be calculated using the following formulas as suggested in the previous Caliway 
studies: 
 
CBL-514 480 mg: Subcutaneous Fat Volume(mL) = Subcutaneous Fat Thickness(cm) × 240 cm2 
CBL-514 640 mg: Subcutaneous Fat Volume(mL) = Subcutaneous Fat Thickness(cm) × 320 cm2 
CBL-514 800 mg: Subcutaneous Fat Volume(mL) = Subcutaneous Fat Thickness(cm) × 400 cm2 
 
- 
Stage 2: Assuming the treatment area is 300 cm2 (which is the area for the maximum dose 
of 50 injections) subcutaneous fat volume over treated area will be calculated using the 
following formula as suggested in the previous Caliway studies: 
 
Subcutaneous Fat Volume(mL) = Subcutaneous Fat Thickness(cm) × 300 cm2 
 
• 
Baseline: The baseline value is defined as the last available valid (quantifiable continuous or 
categorical value), non-missing observation for each participant prior to first study drug 
administration. Repeat and unscheduled assessments will be included in the derivation of the 
baseline values. 
• 
Change from Baseline: The change from baseline value is defined as the difference between the 
result collected/derived at a post-baseline visit/time point and the baseline value. 
The change from baseline value at each post-baseline visit/time point will be calculated for all 
continuous parameters using the following formula: 
Change from Baseline Value = Result at Visit/Time Point – Baseline Value 
 
- 
The change of subcutaneous fat thickness and fat volume from baseline value at a post-baseline 
visit/time point will be calculated using the following formulas: 
 
Change of Subcutaneous Fat Thickness from Baseline Value = Subcutaneous fat 
thickness value at Visit/Time Point – Subcutaneous fat thickness value at Baseline 
Change of Subcutaneous Fat Volume from Baseline Value = Subcutaneous Fat 
Volume value at Visit/Time Point – Subcutaneous fat volume value at Baseline 
 
The change from baseline value will only be calculated if the specific post-baseline visit/time 
point result and the baseline value for the parameter are both available and will be treated as 
missing otherwise. 
 
• 
Percent Change from Baseline: The percent change from baseline value is defined as the 
difference between the result collected/derived at a post-baseline visit/time point and the 
baseline value and then divide by the baseline value which will be multiplied by 100 to display 
as a percentage. 


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The percent change from baseline value at each post-baseline visit/time point will be calculated 
for all continuous parameters using the following formula: 
Percent Change from Baseline Value = 
Result at Visit – Baseline Value
Baseline Value
 × 100 
The percent change from baseline value will only be calculated if the specific post-baseline 
visit/time point result and the baseline value for the parameter are both available and will be 
treated as missing otherwise. 
• 
Study day: The study day of an event is defined as the relative day of the event starting with the 
date of the first study drug administration (reference date) as Day 1 (there will be no Day 0). 
The study day of events occurring before the first study drug administration will be calculated as: 
Study Day = (Date of Event - Date of First Study Drug Administration)  
For events occurring on or after Day 1, study day will be calculated as: 
Study Day = (Date of Event - Date of First Study Drug Administration) + 1 
Study days will only be calculated for events with complete dates and will be undefined for 
events that are ‘Ongoing’ at the end of the study. 
Relative days compared to an alternative reference point will be calculated similarly, but the 
alternative starting reference start date will be used instead of the date of the first study drug 
dosing. 
• 
Prior Medications: Prior medications are defined as any medication where the use was stopped 
prior to the first administration of the study medication. 
• 
Concomitant Medications: Concomitant medications are defined as any medication (other than 
the study drug) that was used at least once after the first administration of the study drug. 
Medications that were stopped on the same date as the first study drug administration will be 
defined as concomitant medications. If a clear determination cannot be made (partial medication 
end dates) the medication will be classified as concomitant 
• 
Treatment Emergent Adverse Events (TEAEs): TEAEs are defined as adverse events that 
occurred following the first administration of study medication. 
• 
Treatment related TEAEs: Treatment related TEAEs include the TEAEs which are deemed 
definitely, probably, or possibly related to study drug. 
• 
Conversion of categorical values: In some instances, continuous variables are expressed as a 
range (i.e. < 10). In such cases, values may be converted to the range boundary (upper or lower 
limit as applicable). As an example, a value of <10 may be converted to 10. Such substitutions 
will be clearly documented in the footnotes of relevant outputs.  
3.3 
Multiple Comparisons and Multiplicity Adjustments. 
All analyses will be performed without adjustment for multiple endpoints. 
 
3.4 
Handling of Missing Data 
For the classification of Treatment emergent adverse event (TEAE) and Concomitant medication, the 
following will be applied in the following order: 
a. 
If all dates/times (start and stop) missing, the event/medication will automatically be classified 
as a TEAE/Concomitant medication. 
b. 
For AEs with a missing start date/time, if the event end date/time is prior to first study drug 
administration, the event will not be classified as a TEAE. 


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c. 
If only the AE start year/ medication end year is present and is the same or is after the first study 
drug administration year unit, the event/medication will be classified as a TEAE/Concomitant 
medication. 
d. 
If the AE start month and year/medication end month and year are present and are the same or 
after the first study drug administration month and year units, the event/medication will be 
classified as a TEAE/Concomitant medication. 
3.5 
Coding of Events and Medications 
Medical history and AE verbatim terms will be coded using the Medical Dictionary for Regulatory 
Activities (MedDRA) using the latest version available at the time of study commencement. Terms 
will be coded to the full MedDRA hierarchy, but the system organ class (SOC) and preferred terms 
(PT) will be of primary interest for the analysis. 
Prior and concomitant medications will be coded using the World Health Organization Drug 
Dictionary using the latest version available at the time of study commencement. Medications will be 
mapped to the full WHO-DD Anatomical Therapeutic Chemical (ATC Level 4) class hierarchy, but 
PTs will be of primary interest in this analysis. 
3.6 
Treatment Groups 
Descriptive analyses will display the following treatment groups: 
 
Stage 1: 
• 
CBL-514 320 mg 
• 
CBL-514 480 mg 
• 
CBL-514 640 mg 
• 
CBL-514 800 mg 
• 
Stage 1 Overall 
 
Stage 2: 
• 
CBL-514 600 mg 
• 
Placebo 
• 
Stage 2 Overall 
 
Descriptive summary analysis of continuous and categorical variables will be conducted as described 
in section 3.1. 


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4. 
ANALYSIS POPULATIONS 
In this study 3 analysis populations are defined: The Intent-to-Treat (ITT), Safety population and Per 
Protocol (PP). 
Furthermore, any additional exploratory analysis not identified in the SAP will be identified in the final 
CSR as exploratory post hoc analyses, including analyses for additional study populations or 
subgroups of interest. 
4.1 
Population Descriptions 
4.1.1 
Intent-to-treat (ITT Population) 
All assigned or randomized subjects, regardless of whether they receive treatment or not, will be 
included in the ITT population. Summaries, listings, and analyses by treatment group will be based on 
the subject’s randomly assigned treatment, not what they actually received.  
All demographic data analysis will be based on the ITT population. All listings will be presented by 
the ITT population. 
4.1.2 
Full Analysis Set Population (FAS Population) 
The full analysis set (FAS) population will be defined as all randomized subjects who receive at least 
one course of IP and contribute qualified baseline and at least one post-dose efficacy assessment 
measured by ultrasound. 
4.1.3 
Safety Population  
The Safety population will be defined as all randomized participants who received at least one dose of 
study drug and will be based on actual treatment received. Screen failures and randomized subjects 
who did not receive any medication will be excluded from the safety analysis set. 
All safety analyses will be based on the Safety population. 
4.1.4 
Per Protocol (PP) population 
Stage 1: 
1. 
A subset of FAS population 
2. 
Subjects without any efficacy related major protocol violations 
3. 
Subjects who complete the proposed dosing schedule of study drug (i.e. did the participant 
complete the study= Yes) and complete all follow-up visits after treatment 
4. 
Subjects whose body weight remain stable throughout the study, identified as having body weight 
change < 3% based on Day 1 body weight. When the body weight data is missing, the subject 
will be regarded as having a stable body weight. 
However, a subject who was discontinued due to an AE, or died before the required exposure could be 
met, will still be included in this population. 
Stage 2: 
1. 
A subset of FAS population 
2. 
Subjects without any efficacy related major protocol violations 
3. 
Subjects who complete all proposed dosing schedules of study drug (i.e., did the participant 
complete the study= Yes) and complete 2 follow-up visits after treatment (including the 
subject who has dose adjustment judged by the Investigator) 
4. 
Subjects have all visits of IP administration within 6 weeks 


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5. 
Subjects whose body weight remain stable throughout the study, identified as having body 
weight change < 2.5 kg compared to last visit and change of body weight < 3 kg compared to 
Day 1 body weight 
6. 
Subjects whose Visit 6 is performed 3 to 5 weeks post final treatment 
7. 
Subjects whose Visit 7 is performed 7 to 9 weeks post final treatment 
However, a subject who was discontinued due to an AE, or died before the required exposure could be 
met, will still be included in this population. (Such subject should continue to satisfy the PP population 
criteria outlined in items 1, 2 and 5 above; Furthermore, if scheduled visits attended by the subject. 
That must adhere to the specified time frames outlined in items 4, 6 and 7 above.)   
 
 


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5. 
PARTICIPANT DISPOSITION AND ANALYSIS POPULATIONS 
Participant disposition and analysis population analysis will be based on all subjects. Participant 
disposition and analysis populations will be summarized descriptively as described in section 3.1 
(categorical descriptive analysis). 
5.1.1 
Participant Disposition 
Participant disposition will include the number of subjects screened, enrolled, screen fails, participants 
who completed the study as planned and participants withdrawn from the study, as well as the primary 
reason for early termination. Participant disposition will be summarized descriptively. 
5.1.2 
Analysis Populations 
The number of participants included in each study populations will be summarized descriptively. 
In addition, the inclusion of each participant into/from each of the defined analysis populations will be 
presented in the by-participant data listings. 
 
 


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6. 
PROTOCOL DEVIATIONS 
Protocol deviations will be presented for each participant in the by-participant data listings. 
Prior to database lock, all protocol deviations will be reviewed by medical monitors and assigned a 
status of Important if qualifying as such. i.e., efficacy related major protocol violations. 
Protocol deviations and important protocol deviations will be categorized as noted in the Protocol 
Deviation Management Plan version 2.0 dated 13May202. 


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7. 
DEMOGRAPHIC AND BASELINE INFORMATION 
Demographic and baseline information will be summarized descriptively as described in section 3.1. 
7.1 
Demographics 
Demographic variables will be summarized using descriptive statistics in accordance with section 3.1 
based on the ITT population. The following demographic parameters will be analyzed: 
Continuous descriptive analysis: 
• 
Age (years) 
• 
Height (cm) 
• 
Weight (kg) 
• 
BMI (kg/m2) 
Categorical descriptive analysis: 
• 
Sex 
• 
Race 
• 
Ethnicity 
Demographics variables will also be listed by stage and treatment group (section 3.7) under ITT 
population sorted by subject ID. 
7.2 
Medical /Surgical history 
Medical / Surgical history will be coded using the most current Medical Dictionary for Regulatory 
Activities (MedDRA®). Subjects with any past or ongoing medical history will be summarized by 
system organ classification (SOC) and preferred term (PT) using descriptive statistics in accordance 
with section 3.1 for the ITT population by treatment groups defined in section 3.7. Medical history will 
be ordered from the highest frequency in the overall column by SOC and PT. 
Medical history listings will be provided by stage and treatment arm (grouping provided in section 3.7) 
sorted by subject ID for the ITT population, along with ongoing status of medical history and age/sex 
of the subject. 
7.3 
Viral Serology 
Hepatitis B, Hepatitis C and Human Immunodeficiency Virus (HIV) results will be presented by stage 
and treatment arm sorted by subject ID for the ITT population. 
7.4 
Pregnancy 
Listing for pregnancy results will be provided by stage sorted by subject ID for the ITT population. 
7.5 
Follicle Stimulating Hormone Testing 
Women not of childbearing potential must be post-menopausal (defined as at least 50 years with 
cessation of regular menstrual periods for at least 12 months with follicle stimulating hormone > 40 
IU/L). Post-menopausal status will be confirmed through testing of FSH levels at Screening. FSH 
results obtained will be presented in the by-participant data listings only. 
7.6 
Eligibility 
Participant eligibility will be listed in a data listing. 


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8. 
TREATMENT EXPOSURE 
Treatment exposure (total number of injections, total volume administrated, total Dose administrated) 
will be summarized using descriptive statistics in accordance with section 3.1 based on the Safety 
population. All study drug administration information (study drug administered (Yes/No), reason not 
administered, start and end date and time of administration, Lignocaine application, total volume 
administrated, total number of injections, study drug given per protocol (Yes; details of administration/ 
No; Reason not given per protocol) will be presented in the by-participant data listings. 
Total administrated dose can be calculated as below: 
Total Dose Administrated (mg)= Total Volume Administered (mL) × 5 mg/mL 
 
 


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9. 
PRIOR AND CONCOMITANT MEDICATIONS 
Prior and concomitant medications will be coded using the most current version of the World Health 
Organization Drug Dictionary (WHODD). Medications will be mapped to the Anatomical Therapeutic 
Chemical (ATC) Level 4 and preferred term (PT), as the primary interest for the analysis. 
The prior and concomitant medications and therapies are defined as follows.  
1. 
Prior Medications: Prior medications are defined as any medication where the use was stopped 
prior to the first administration of the study medication.  
 
2. 
Concomitant Medications: Concomitant medications are defined as any medication (other than 
the study drug) that was used at least once after the first administration of the study drug. If the 
end time of the medications is unknown, medications that were stopped on the same date as the 
first study drug administration will be defined as concomitant medications. If a clear 
determination cannot be made (partial medication end dates) the medication will be classified 
as concomitant. 
The prior and concomitant medications/therapies are exclusive with each other. 
Prior and concomitant medications will be summarized by Anatomical Therapeutic Chemical (ATC) 
class Level 4 and PT as noted in section 3.1 (categorical descriptive analysis) for the Safety population. 
Participant who used the same medication on multiple occasions will only be counted once in the 
specific category (PT). PTs will be sorted alphabetically. In addition to the summaries by the coded 
terms, the number of participants who used at least one concomitant medication during the study will 
be presented. 
Prior and concomitant medications will be presented in the by-participant data listings for the Safety 
Population. Listing will include concomitant medications/therapy classification, medication taken, start 
and end date/time, ongoing status, reason for administration, dose, unit, dose form, frequency, and 
route of administration. 
 
 
 


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10. 
EFFICACY 
Efficacy will be analyzed in both Stage 1 and Stage 2 of the study. All ultrasound data collected at 
scheduled and unscheduled visits will be included in the listings, but only results collected as 
scheduled visits will be included in the summary tables. 
Stage 1 
Efficacy endpoints to be analyzed in Stage 1 are: 
1. 
Reduction of subcutaneous abdominal fat thickness as measured by ultrasound compared with 
Baseline (Week 4 vs Baseline) 
2. 
Reduction of subcutaneous abdominal fat volume over the treated area as measured by 
ultrasound compared with Baseline. (Week 4 vs Baseline) 
*Note: no efficacy assessments will be done for Group 1 of Stage 1 study. All the information 
collected for thigh fat thickness will be presented in by-subject listing sorted by subject ID for the ITT 
population. 
 
- 
The subcutaneous abdominal fat thickness and fat volume (as defined in section 3.2) at baseline, 
and Week 4, along with the change and percentage change of fat thickness and fat volume from 
baseline will be summarized using descriptive statistics in accordance with section 3.1. 
- 
Within-treatment analysis will be performed by paired t-test for Week 4 vs baseline for reduction 
of subcutaneous fat thickness and fat volume. An estimate of the mean difference in subcutaneous 
fat thickness and fat volume between baseline and Week 4 along with its 95% CI and 
corresponding p-value will also be provided. No claim can be made on these p-values based on this 
efficacy analysis as it is exploratory in nature. These p-values should be used wisely. 
The analysis set for the primary efficacy analysis is the ITT population  
Stage 2 
Primary efficacy endpoints to be analyzed in Stage 2 are: 
1. 
The proportion of subjects who lose at least 150 mL of subcutaneous fat as measured by 
ultrasound compared with placebo. 
Secondary efficacy endpoints to be analyzed in Stage 2 are: 
2. 
Reduction of subcutaneous fat volume over the treated area as measured by ultrasound 
compared with Baseline 
3. 
Reduction of subcutaneous fat volume over the treated area as measured by ultrasound 
compared with placebo 
4. 
Number of treatments required to first occurrence of reducing at least 150 mL of subcutaneous 
fat volume over the treated area as measured by ultrasound in CBL-514 group. 
5. 
The proportion of subjects who lose at least 200 mL of subcutaneous fat as measured by 
ultrasound compared with placebo 


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- 
A summary table presenting the number and proportion of subjects who lose at least 150mL and 
subjects who lose at least 200 mL of subcutaneous fat volume over the treated area together with 
two-sided Clopper-Pearson 95% confidence intervals for each treatment group defined in section 
3.7 will be produced. 
- 
For the subcutaneous fat volume as measured by ultrasound data, summary statistics (as described 
in section 3.1) will be presented for values and change from baseline value at each visit. 
- 
If the assumptions met, the Mixed-Effect Model Repeated Measurement (MMRM) will be used to 
assess the change over time in the CBL-514 and placebo treatment arms for the abdominal 
subcutaneous fat volume. The assumptions for MMRM can be checked as described in section 
16.3.  There will not be any alternative method used if assumptions of model-based analysis are 
not satisfied.  
 
The model will include the following fixed factors/covariates: 
o Baseline subcutaneous fat volume,  
o Treatment Group, 
o  Study Visit, 
o Treatment Group and Study Visit interaction term;  
Subject as random effect and repeated visits will be also included in the model.  
Unstructured within-subject covariance structure (TYPE=UN) will be selected for the model initially 
which makes no assumption about the relationship in the correlation among visits. If it leads to non-
convergence, the following covariance structures will be explored: first order autoregressive (AR (1)), 
Heterogenous Toeplitz, Toeplitz, and compound symmetry, if appropriate. If the model does not 
converge, alternative covariance structures will be investigated. The Akaike Information Criteria (AIC) 
will be used to select the best model (smaller is better).  
If model does not converge after the above, a standard regression model will be fitted at each time 
point using the same covariates as described above.  
The Kenward-Roger (Kenward and Roger 1997) approximation will be used to estimate denominator 
degrees of freedom for tests of fixed effects.  
Also, if the model is complex, simpler model will be explored. 
The LS mean change from baseline, along with corresponding 95% CI and p-values for each treatment 
arm for Visit 3, Visit 4, Visit 5, Visit 6, and Visit 7 will be presented. In addition, the difference in 
change from baseline at Visit 6 and Visit 7 for CBL-514 600 mg versus placebo will be provided for 
the ITT population and repeated for PP Population.  
No claim can be made on these p-values based on this efficacy analysis as it is exploratory in nature. 
These p-values should be used wisely. 
The SAS code sample that can be used to implement the above MMRM analysis is given below: 
 
PROC MIXED DATA= input_data; 
CLASS treat (ref= 'Placebo') visit (ref='Baseline') usubjid; 
MODEL chg= base treat visit treat*visit /ddfm=kr Solution CL; 
REPEATED visit/subject=usubjid  type=UN; 
LSMEANS  treat*visit/pdiff CL alpha=0.05; 
LSMENAS visit/cl; 
ods output lsmeans=lsmeans diffs=diffs; 
run; 
 


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- 
The initial visits during which a subject experience a subcutaneous fat volume loss of 150 mL or 
more will be marked as flagged. For each subject, the number of treatments administered until the 
first flagged visit will be recorded and summarized descriptively along with the number of 
injections, volume and dose administrated in accordance with Section 3.1. In cases where the 
subject is scheduled to receive the study treatment on the same date as the first flagged visit, that 
treatment will not be included in the count. 
 
All the summary and analysis tables will be done for ITT and PP population for treatment groups 
defined in section 3.7.   
 
All analyses will be performed without adjustment for multiple endpoints. 
 
 
 


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11. 
SAFETY  
Safety endpoints will be analyzed using the Safety population. Safety endpoints will be summarized 
descriptively as described in section 3.1. 
11.1 
Adverse Events 
AEs and serious AEs (SAEs) are defined in the study protocol. 
Treatment Emergent Adverse Events (TEAEs) are defined as adverse events that occurred following 
the first administration of study medication. If missing dates or time prevent a clear determination as to 
whether the AE is treatment emergent, the adverse event will be regarded TEAE. 
All AE verbatim terms will be coded using the most recent version of MedDRA. All AE summaries 
will be restricted to include TEAEs only. AEs occurring prior to first dose of study medication will be 
listed but not included in any tabulations. Summary tables will include the number of participants (%) 
experiencing an event and the number of events. Participants will be counted only once for each SOC 
and PT level (categorical descriptive analysis). 
The TEAE summaries will include: 
• 
Overall summary of TEAEs. 
• 
Summary of TEAEs by SOC, PT and Relationship. 
• 
Summary of TEAEs by SOC, PT and Severity. 
• 
Summary of Definitely Related TEAEs by SOC, PT and Severity 
• 
Summary of Probably or Possibly Related TEAEs by SOC, PT and Severity 
• 
Summary of TEAEs of Special Interest by SOC, PT and Severity 
• 
Summary of serious TEAEs by SOC and PT. 
• 
Summary of Treatment Related serious TEAEs by SOC and PT 
• 
TEAE summary of events leading to the study drug withdrawal by SOC and PT. 
• 
Treatment Related TEAE summary of events leading to the study drug withdrawal by SOC and 
PT 
 
For the ‘Overall Summary of TEAEs’, the following items will be included:  
1. 
Any TEAEs  
2. 
Any serious TEAEs  
3. 
Any TEAEs leading to study discontinuation 
4. 
Any TEAEs of special interest  
5. 
Any related TEAE 
6. 
Any TEAEs leading to study discontinuation 
7. 
Any TEAEs leading to death 
 
All AEs will be listed and will include the start and stop date and time of AEs, AE number, verbatim 
term, Preferred Term, System Organ Class, SAE/TEAE flag, actions taken for AE, relationship to 
study treatment and outcome.  
Separate by-participant data listings will be created for SAEs, AEs leading to study discontinuation, 
and AEs leading to death. These listings will be presented by participant ID and AE start date/time for 
the Safety Population. 
 


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11.2 
Safety Laboratory Assessments 
Blood and urine samples will be collected at the time points specified in the Schedule of Events (refer 
to the Protocol) to conduct hematology, chemistry and urinalysis (including microscopic examinations) 
analyses. 
 
The following tests will be performed within each of the specified test panels: 
Hematology: 
1. 
Hemoglobin (Hb) 
2. 
Hematocrit (Hct) 
3. 
Erythrocytes (RBC) 
4. 
Platelets (PLAT) 
5. 
Leukocytes (white blood cells [WBCs]) with differential (including Eosinophils [ESN], 
Neutrophils [NEUT], Basophils [BASO], Lymphocytes [LYM], and Monocytes [MONO]) 
6. 
Mean corpuscular volume. 
Biochemistry: 
1. 
Urea (U) 
2. 
Creatinine (CREAT) 
3. 
TBIL 
4. 
Albumin (ALB) 
5. 
ALKP (ALP) 
6. 
AST 
7. 
ALT 
8. 
GGT 
9. 
Estimated Glomerular Filtration Rate (eGFR) 
10. 
Glycated hemoglobin (HbA1c) 
11. 
Fasting Blood Sugar (FBS) 
12. 
Sodium (NA) 
13. 
Potassium (K) 
14. 
Chloride (CL) 
15. 
Bicarbonate (BICARB) 
16. 
Triglyceride 
17. 
Total cholesterol 


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18. 
LDL-C 
19. 
HDL-C 
Coagulation: 
20. 
International Normalized Ratio (INR) 
21. 
Activated Partial Thromboplastin Time (aPTT) 
22. 
Prothrombin Time. 
Urinalysis & Microscopic Urinalysis: 
A urinalysis test (dipstick) will be performed for each subject. If clinically significant abnormality is 
noted for protein, blood, or leukocyte esterase (and at the discretion of the Investigator) a microscopic 
examination of RBC, WBC, bacteria, and casts will be performed. 
 
All laboratory data collected at scheduled and unscheduled visits will be included in the listings, but 
only results collected as scheduled visits will be included in the summary tables. 
Results for individual parameters may be reported in different units depending on the analyzing 
laboratory. If required, the results (and the corresponding normal range cut-off values) for individual 
parameters may be converted to International System of Units (S.I.) units to summarize the data. 
For all the parameters where a unit value has been reported, the parameter names that will be used in 
the outputs will comprise of the test name and the unit of measure, for example, ‘Albumin (g/L)’. For 
the urinalysis parameters, the parameter name will be the reported test name only. Parameters will be 
sorted alphabetically within tables and listings. 
For all parameters where a normal range limit value was reported, the normal range will be derived 
based on the available lower and upper limit values and any reported mathematical symbols. If both a 
lower and upper limit value is available, the normal range will be presented as ‘(Lower, Upper)’. 
The reported results for each parameter with a defined normal range will be classified (‘Low’, 
‘Normal’, ‘High’) in relation to the defined normal range limits. If a result is equal to the normal range 
cut-off value, the result will be considered ‘Normal’. 
The hematology and chemistry results tables will present summary statistics for each laboratory 
parameter within the specific test panel. For each parameter, summaries will be presented for the 
baseline and each scheduled post-baseline visit. In addition, summaries will be presented for the 
change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). 
The change from baseline values at each post-baseline visit will be calculated for all parameters with 
continuous results (except for pH and Specific Gravity). The abnormal urinalysis result (dipstick and 
microscopy), if applicable, will be listed only. 
The decimal precision to which the summaries for each parameter will be based on the maximum 
number of decimals to which the reported result or the normal range limits are presented to in the raw 
data. The results and normal ranges will be displayed to the same decimal precision in the listings. 
Additionally, counts (%) of number participants with values out of normal range at each scheduled 
time point will also be presented along with shift tables that will represent the changes in normal range 
categories across post-baseline time points (categorical descriptive analysis). 
The urinalysis table will present counts and percentages of normal, abnormal clinically significant and 
clinically significant for the reported results at baseline and each post-baseline visit for all parameters 
(categorical descriptive analysis). 


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11.3 
Vital Signs 
The following vital signs measurements will be taken at the time points specified in the Schedule of 
Events (refer to the Protocol): 
1 
Pulse Rate (beats/min); 
2 
Systolic blood pressure (SBP) (mmHg) 
3 
Diastolic blood pressure (DBP) (mmHg) 
4 
Respiratory rate (breaths/min) 
5 
Body temperature (ºC) 
All vital signs data collected at scheduled and unscheduled visits will be included in the listings, but 
only results collected as scheduled visits will be included in the summary tables. 
The parameter names that will be used in the outputs will comprise of the test name and the unit of 
measure, for example, ‘Systolic Blood Pressure (mmHg)’. Parameters will be sorted in the order that 
the measurements were collected in on the Vital Signs eCRF page within the tables and listings. 
Vital signs measurements will present summary statistics for the results at the baseline and each 
scheduled post-baseline visit for each of the parameters. In addition, summaries will be presented for 
the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). 
The decimal precision to which the summaries for each parameter will presented will be based on the 
maximum number of decimals to which the results were reported on the eCRF. 
11.4 
12-Lead Electrocardiogram (ECG) 
The following ECG measurements will be taken at the time points specified in the Schedule of Events 
(refer to the Protocol): 
1 
Heart Rate (bpm) 
2 
PR Interval (msec) 
3 
QT Interval (msec) 
4 
QTcF Interval (msec) 
5 
QRS Duration (msec) 
6 
ECG clinical interpretation 
All ECG data collected at scheduled and unscheduled visits will be included in the listings, but only 
results collected as scheduled visits will be included in the summary tables. 
The parameter names that will be used in the outputs will comprise of the test name and the unit of 
measure, for example, ‘Ventricular Rate (beats/min)’. Parameters will be sorted in the order that the 
measurements were collected in on the ECG eCRF page within the tables and listings. 
ECG measurements will present summary statistics for the results at the baseline and each scheduled 
post-baseline visit for each of the parameters. In addition, summaries will be presented for the change 
from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). 
The decimal precision for each parameter will be based on the maximum number of decimals to which 
the results were reported on the eCRF. 
The summary of overall interpretation findings table will present counts and percentages for the 
reported results at baseline and each post-baseline visit/time point. Result categories will be ordered as 
‘Normal’, ‘Abnormal Not Clinically Significant (NCS)’ and ‘Abnormal Clinically Significant (CS)’ 
(categorical descriptive analysis). 


Protocol Number: CBL-0202 
 
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Document status:  Addendum 1.0 
 
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Page 33 of 50 
11.5 
Physical Examinations 
Complete physical examinations will be performed by a licensed physician at the time points specified 
in the study schedules. 
A complete physical examination will include, at a minimum, assessments of the cardiovascular, 
respiratory, gastrointestinal, and neurological systems. 
By-subject data listings will be presented at the time points collected for complete physical 
examination parameters and Symptom directed physical examination parameters. 
11.6 
Pregnancy and Follicle Stimulating Hormone (FSH) Tests 
All information related to pregnancy testing (urine and serum based) and contraception status will be 
presented in the by-participant data listings. Follicle stimulating hormone (FSH) test for 
postmenopausal women will be presented in the data listing. 
 
 
 


Protocol Number: CBL-0202 
 
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Document status:  Addendum 1.0 
 
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12. 
IMMUNOGENICITY 
Not Applicable for this study. 
 
 


Protocol Number: CBL-0202 
 
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Document status:  Addendum 1.0 
 
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Page 35 of 50 
13. 
CHANGES TO THE PLANNED ANALYSIS 
Not applicable. 


Protocol Number: CBL-0202 
 
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Document status:  Addendum 1.0 
 
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Page 36 of 50 
14. 
INTERIM AND FINAL ANALYSIS 
14.1 
Interim Analysis 
No Interim analysis planned for this study. 
14.2 
Final Analysis (End of Study) 
The final analysis will be conducted after all participants have completed the study, the clinical 
database has been locked, the analysis populations have been approved and the study has been 
unblinded. 
The final analysis will be based on the final version of SAP. Any deviations from the planned analysis 
will be documented in the CSR. 
 
 


Protocol Number: CBL-0202 
 
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Document status:  Addendum 1.0 
 
 - Strictly Confidential 
Page 37 of 50 
15. 
SOFTWARE 
• 
SAS® Version 9.2 or higher (SAS Institute, Cary, North Carolina, USA). 
 
 




Protocol Number: CBL-0202 
 
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Document status:  Addendum 1.0 
 
 - Strictly Confidential 
Page 39 of 50 
Hepatitis B Virus; Hct: Hematocrit; HCV: Hepatitis C Virus; HDL-C: High-density 
lipoprotein cholesterol; HIV: Human immunodeficiency virus; INR: International normalized 
ratio; IP: Investigational product; ISR: Injection site reaction; LDL-C: Low-density 
lipoprotein cholesterol; RBC: Red blood cell; SAE: Serious adverse event; TBIL: Total 
bilirubin; WBC: White blood cell; WOCBP: Woman of childbearing potential. 
* Available measurements of clinical evaluations (physical examinations, vital signs, and ECG) 
and laboratory evaluations (biochemistry, hematology, coagulation, and urinalysis) within 14 
days prior to IP dose can be accepted as the Baseline value and will not necessitate duplicate 
examinations. 
* If study drug dose is within 7 days of Screening pregnancy test, pregnancy test at Visit 2 (Day 1) 
will not be necessary to assess. 
* In cases where more than 1 data is available for a certain evaluation, the latest value prior to the 
study drug administration will be used as the Baseline value. 
1  
Details of concurrent medical conditions, prior surgical procedures, and chronic diseases or 
other significant medical events prior to Screening will be collected. Any other non-
significant medical events within 6 months prior to Screening will also be collected. Prior 
medications include a complete history of previous treatment/medications within 6 months 
prior to Screening. 
2  
Subject diaries will be provided to the subjects on Day 1. The subjects will be asked to record 
if there are any changes to the injection site/s or any discomforts from Day 1 until last clinic 
visit or when all ISRs have resolved or stabilized. The diary will be reviewed at the following 
visits as needed. 
3  
Anthropometric parameters to be collected include body height and body weight.  Body height 
will be measured at Screening only. Thigh circumference will be collected only for Group 1 
(320 mg) in Stage 1 study. 
4  
Ultrasound – Thickness of fat will be obtained by ultrasonic measurements across target area. 
Abdominal or thigh ultrasound will be performed at Screening, Day 1, and Week 4. 
Abdominal or thigh ultrasound may be performed within 4 days before Day 1 and up to 4 
days before/after Week 4 follow-up visit. Day 1 ultrasound can be exempted if the screening 
ultrasound is performed within 4 days prior to IP dose, and the screening ultrasound can be 
accepted as the Baseline value. 
5  
A complete physical examination will include, at a minimum, assessments of the 
cardiovascular, respiratory, gastrointestinal, and neurological systems. 
6  
On Day 1, injection site assessments will be performed pre-dose and at 1-hour post-dose. 
7  
On Day 1, vital signs assessments to be performed pre-dose and at 1-hour post-dose. Vital sign 
assessments include temperature, pulse rate, blood pressure, and respiratory rate. At 
simultaneously scheduled assessments, vital signs will be collected prior to any blood draws. 
8  
On Day 1, ECG assessments will be performed pre-dose only. ECG to be performed in supine 
position after at least 5 minutes rest. The following ECG parameters will be recorded: heart 
rate, RR interval, PR interval, QT interval, QTc interval, and QRS interval. 
9  
Blood tests include biochemistry, hematology, and coagulation assessments. Biochemistry 
assessments include albumin, ALT, AST, ALP, triglyceride, total cholesterol, LDL-C, HDL-
C, TBIL, GGT, urea, creatinine, eGFR, HbA1c, FBS, Sodium, Potassium, Bicarbonate, and 
Chloride. Hematological assessments include Hb, Hct, RBC count, mean corpuscular volume, 
Leukocyte/white blood cell (WBC) count, WBC differential, and platelet count. Coagulation 
assessments include aPTT, Prothrombin time, and INR. 
10  Urinary samples for dipstick will be collected. On Day 1, collection will be performed pre-
dose only. 


Protocol Number: CBL-0202 
 
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Document status:  Addendum 1.0 
 
 - Strictly Confidential 
Page 40 of 50 
11  Serum β-hCG test will be taken for WOCBP at Screening visit only. FSH test is required for 
females who are post-menopausal at the Screening visit. Urine β-hCG strip test will be taken 
WOCBP for other scheduled visits. 
12  Virology tests include HIV/HBV/HCV infection test. Active HIV infection is detected by 
detectable positive HIV Ag/Ab combo test; active HBV: HBsAg; active HCV: positive anti-
HCV antibody. 
13  On Day 1, photography will be performed pre-dose and at 1 hour post-dose on Day 1. Other 
timepoints on Day 1 can be added to record the ISR at the discretion of the Investigator. 
14  The occurring AEs/SAEs (including AESI) will be followed until resolution or the event is 
considered stable. 
15  Collected only if a medication is related to AEs following the visit 4. 
16  Assessment/collection can be performed on or within 4-days window prior to visit date. 
17  Abdominal or thigh ultrasound only applicable to ET visit and not required for Week 2 visit. 
18  At Week 1, only body weight will be measured and collected for anthropometric parameter. 
 
 




Protocol Number: CBL-0202 
 
2023-09-19 
Document status:  Addendum 1.0 
 
 - Strictly Confidential 
Page 42 of 50 
AE: Adverse event; AESI: Adverse event of special interest; Ag/Ab: Antigen/antibody; 
ALP/ALKP: Alkaline phosphatase; ALT: Alanine aminotransferase; aPTT: Activated partial 
thromboplastin time; AST: aspartate aminotransferase; β-hCG: Beta human chorionic 
gonadotropin; BMI: Body mass index; ECG: Electrocardiogram; eGFR: Estimated 
glomerular filtration rate; EOT: End of treatment: EOS: End of study; ET: Early Termination; 
FBS: Fasting blood sugar; FSH: Follicle stimulating hormone; GGT: Gamma-glutamyl 
transferase; Hb: Hemoglobin; HbA1c: Hemoglobin A1c; HBV: Hepatitis B Virus; Hct: 
Hematocrit; HCV: Hepatitis C Virus; HDL-C: High-density lipoprotein cholesterol; 
HIV: Human immunodeficiency virus; INR: International normalized ratio; ISR: Injection 
site reaction; LDL-C: Low-density lipoprotein cholesterol; RBC: Red blood cell; SAE: 
Serious adverse event; TBIL: Total bilirubin; WBC: White blood cell; WOCBP: Woman of 
childbearing potential. 
* 
Available measurements of clinical evaluations (physical examinations, vital signs, and ECG) 
and laboratory evaluations (biochemistry, hematology, coagulation, and urinalysis) within 14 
days prior to CBL-514 or Placebo dose can be accepted as the Baseline value and will not 
necessitate duplicate examinations. 
*  If study drug dose is within 7 days of Screening pregnancy test, pregnancy test at Visit 2 
(Day 1) will not be necessary to assess. 
*  In cases where more than 1 data is available for a certain evaluation, the latest value prior to 
the study drug administration will be used as the Baseline value. 
** The first follow up visit (Visit 6) should be performed 4 weeks post the final treatment. If 
treatment is cancelled at Visits 3, 4 or 5 due to the insufficient abdominal fat, it is 
recommended that first follow up visit is performed on the same day of the treatment 
cancellation. If not, then +7 days visit window should be utilized to schedule another day to 
complete the first follow up visit. 
1  
Details of concurrent medical conditions, prior surgical procedures and chronic diseases or 
other significant medical events prior to Screening will be collected. Any other non-
significant medical events within 6 months prior to Screening will also be collected. Prior 
medications include a complete history of previous treatment/medications within 6 months 
prior to Screening. 
2  
Anthropometric parameters include body height, body weight and abdominal skinfold 
thickness measured by caliper. Body weight will be measured at all visits to calculate the 
BMI. Body height and abdominal skinfold thickness (by caliper) will be measured at 
Screening only. 
3  
Ultrasound – Thickness of fat will be obtained by ultrasonic measurements across target area. 
Abdominal ultrasound will be performed within 4 days before Visit 2 (Day 1), Visits 3, 4 and 
5; and 4 days before/after the follow-up visits. 
Assessment/Schedul
e 
Screeni
ng 
Treatment 
Follow-up 
Visit 
1 
2 
3 
4 
5/EOT 
**6/ET 
7/EOS 
Day 
-28 to -1 
1* 
(Visit 2 
+ 4 
weeks) 
(Visit 3 
+ 4 
weeks) 
(Visit 4 
+ 4 
weeks) 
(Visit 5 
+ 4 
weeks) 
(Visit 5 
+ 8 
weeks) 
Visit window 
 
- 
+ 7days 
+ 7days 
+ 7days 
± 7days 
± 7days 
Concomitant 
Medication 
 
X 
X 
X 
X 
X 
X15 


Protocol Number: CBL-0202 
 
2023-09-19 
Document status:  Addendum 1.0 
 
 - Strictly Confidential 
Page 43 of 50 
4  
A complete physical examination will include, at a minimum, assessments of the 
cardiovascular, respiratory, gastrointestinal, and neurological systems and will be performed 
pre-dose. 
5  
On Visit 2 (Day 1), Visit 3, Visit 4, and Visit 5, the injection site assessments will be 
performed pre-dose and post-dose. Subjects will document any change to the ISRs in between 
visits in the Subject Diaries. 
6  
On Visit 2 (Day 1), Visit 3, Visit 4, and Visit 5, vital signs assessments to be performed pre-
dose. Vital sign assessments include temperature, pulse rate, blood pressure, and respiratory 
rate. 
7  
On Visit 2 (Day 1), ECG assessments will be performed pre-dose. ECG to be performed in 
supine position after at least 5 minutes rest. The following ECG parameters will be recorded: 
heart rate, RR interval, PR interval, QT interval, and QRS interval. 
8  
Blood tests include biochemistry, hematology, and coagulation assessments. Biochemistry 
assessments include albumin, ALT, AST, ALP, triglyceride, total cholesterol, LDL-C, HDL-
C, TBIL, GGT, urea, creatinine, eGFR, HbA1c, FBS, Sodium, Potassium, Bicarbonate, and 
Chloride. Hematological assessments include Hb, Hct, RBC count, mean corpuscular volume, 
WBC count, WBC differential, and platelet count. Coagulation assessments include aPTT, 
Prothrombin time, and INR. 
9  
Urinary samples for dipstick will be collected. 
10  Serum β-hCG test will be taken for WOCBP at Screening visit only. FSH test is required for 
females who are post-menopausal at Screening visit. Urine β-hCG strip test will be taken for 
WOCBP for other scheduled visits. 
11  Virology tests include HIV/HBV/HCV infection test. Active HIV infection is detected by 
detectable positive HIV Ag/Ab combo test; HBV: HBsAg; HCV: positive anti-HCV antibody. 
12  On Visit 2 (Day 1), Visit 3, Visit 4, and Visit 5, the photography will be performed pre-dose. 
The post-dose photography will be performed only when any severe or unusual ISR was 
observed and assessed by Investigator after IP administration.  
13  The occurring AEs/SAEs (including AESI) will be followed until resolution or the event is 
considered stable. 
14  On follow-up visits, no subject diary will be provided to subjects and only review and 
recording of subject dairy entries will be conducted. 
15  Collected only if a medication is related to AEs following the Visit 6 
16  Assessment/collection can be performed on or within 4-days window prior to visit date. 
17  Eligible subjects will be randomly assigned to either the CBL-514 group or placebo group at 
a ratio of 2:1.  
18. ECG assessment can be performed on or within 4 days before or after Visit 6/ET 
 
 
 
 


Protocol Number: CBL-0202 
 
2023-09-19 
Document status:  Addendum 1.0 
 
 - Strictly Confidential 
Page 44 of 50 
16.3 
Appendix 3: MMRM Assumptions Testing 
 
a) Sphericity assumption 
The first assumption of the MMRM analysis is sphericity, posits that the repeated measures of a 
within-subjects effect should have equal variances and constant covariances. 
• 
When the sphericity assumption is satisfied, the F-test in a standard analysis of variance is 
appropriate. 
• 
When the sphericity assumption is violated, the F-test in a standard analysis of variance will be 
positively biased; that is, it will be more likely to make a Type I error (i.e., reject the null 
hypothesis when it is, in fact, true). 
• 
Violation of sphericity was corrected using the Greenhouse–Geisser method. 
 
b) Normality assumption 
Kolmogorov-Smirnov normality test will be used to check normality of the data and the results will be 
presented. 
 
SAS Proc to be used for normality testing: 
ods output TestsForNormality = Normal; 
proc univariate data=input normal plots; 
var CFB; *CFB=Change from baseline; 
histogram Diff /normal; 
qqplot /normal (mu=est sigma=est); 
run; 
ods output close; 
data Normality; 
set Normal (where = (Test = 'Kolmogorov-smirnov')); 
if pValue > 0.05 then Status ="Normal"; 
else Status = "Non-normal"; 
drop TestLab Stat pType pSign; 
run; 
 
Perform the following steps to check the normality of data. 
 
1. 
First, check normality of data by pooling all visits data together if normality is achieved 
perform the parametric test. 
2. 
If overall data doesn’t show normality, check normality at each timepoint and if only few 
timepoints achieve normality, then still perform parametric test as normality can be assumed 
for non-normal timepoint. 
3. 
If extreme outliers are present, then remove the outliers and check normality to perform 
parametric test.  
4. 
Other normality tests result will be explored in case of departure from normality assumption.  
5. 
If normality assumption is still violated, the normality will be assumed to perform parametric 
tests.  
 
c) Test for Homoscedasticity  
Homogeneity of variances between two treatment groups will be tested using Levene’s test.  


Protocol Number: CBL-0202 
 
2023-09-19 
Document status:  Addendum 1.0 
 
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Page 45 of 50 
proc glm;  
class treat;  
model CHG = treat;  
means treat / hovtest=levene welch;  
run;  
 
Note that only the results from the HOVTEST= and WELCH options in PROC GLM account for  
variance heterogeneity. All other results assume equal variances. If heteroscedasticity occurs, all the  
results will be adjusted for unequal variances by adding the DDFM=SATTERTHWAITE option in the  
MODEL statement to adjusts the degrees of freedom for the unequal variances. 
 
 


Protocol Number: CBL-0202 
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Document status:  Addendum 1.0 
 
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Page 46 of 50 
17. 
TABLES AND LISTINGS 
 
TABLES 
 
14.1 Demographics and Other Baseline Characteristics 
Table 14.1.1.1 Summary of Participant Enrolment and Disposition- Stage 1 (All subjects)  
Table 14.1.1.2 Summary of Participant Enrolment and Disposition- Stage 2 (All subjects)  
Table 14.1.2.1 Summary of Demographics and Baseline Characteristics- Stage 1 (ITT Population) 
Table 14.1.2.2 Summary of Demographics and Baseline Characteristics- Stage 2 (ITT Population) 
Table 14.1.3.1 Summary of Treatment Exposure- Stage 1 (Safety Population) 
 
Table 14.1.3.2 Summary of Treatment Exposure- Stage 2 (Safety Population) 
14.2 Efficacy  
Table 14.2.1.1.i Summary of Abdominal Fat Thickness- Stage 1 (ITT Population) 
Table 14.2.2.1.i Summary of Abdominal Fat Volume- Stage 1 (ITT Population)  
Table 14.2.3.1.i Paired T-Test Results for Fat Thickness Change from Baseline- Stage 1 (ITT Population)  
Table 14.2.4.1.i Paired T-Test Results for Fat Volume Change from Baseline - Stage 1 (ITT Population)  
Table 14.2.2.2.i Summary of Abdominal Fat Volume- Stage 2 (ITT Population)  
Table 14.2.2.2.ii Summary of Abdominal Fat Volume- Stage 2 (PP Population)  
Table 14.2.5.2.i Summary of Subjects With At Least 150ml and 200ml Fat Volume Reduction from Baseline- Stage 2 (ITT Population) 
 
Table 14.2.5.2.ii Summary of Subjects With At Least 150ml and 200ml Fat Volume Reduction from Baseline- Stage 2 (PP Population) 
 
Table 14.2.6.2.i Statistical Analysis for Fat Volume Change from Baseline- Stage 2 (ITT Population) 
 
Table 14.2.6.2.ii Statistical Analysis for Fat Volume Change from Baseline- Stage 2 (PP Population) 
 
Table 14.2.7.2.i Summary of Treatments Required to First Occurrence Of At Least 150ml Of Fat Volume - Stage 2 (ITT Population) 
 
Table 14.2.7.2.ii Summary of Treatments Required to First Occurrence Of At Least 150ml Of Fat Volume - Stage 2 (PP Population) 
14.3 Safety 
 
Table 14.3.1.1 Summary of Prior Medications- Stage 1 (Safety Population) 
Table 14.3.1.2 Summary of Prior Medications- Stage 2 (Safety Population) 
 
Table 14.3.2.1 Summary of Concomitant Medications- Stage 1 (Safety Population) 
 
Table 14.3.2.2 Summary of Concomitant Medications- Stage 2 (Safety Population) 
14.3.3 Adverse Events 
Table 14.3.3.1.1 Overall Summary of Treatment Emergent Adverse Events- Stage 1 (Safety Population)  
Table 14.3.3.1.2 Overall Summary of Treatment Emergent Adverse Events- Stage 2 (Safety Population)  
Table 14.3.3.2.1 Summary of Treatment Emergent Adverse Events By SOC, PT And Relationship- Stage 1 (Safety Population) 
 
Table 14.3.3.2.2 Summary of Treatment Emergent Adverse Events By SOC, PT And Relationship - Stage 2 (Safety Population) 
 


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Document status:  Addendum 1.0 
 
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Table 14.3.3.3.1 Summary of Treatment Emergent Adverse Events By SOC, PT And Severity- Stage 1 (Safety Population) 
 
Table 14.3.3.3.2 Summary of Treatment Emergent Adverse Events By SOC, PT And Severity- Stage 2 (Safety Population) 
 
Table 14.3.3.4.1 Summary of Definitely Related TEAEs by SOC, PT And Severity- Stage 1 (Safety Population)  
Table 14.3.3.4.2 Summary of Definitely Related TEAEs by SOC, PT And Severity- Stage 2 (Safety Population)  
Table 14.3.3.5.1 Summary of Probably or Possibly Related TEAEs by SOC, PT And Severity- Stage 1 (Safety Population) 
 
Table 14.3.3.5.2 Summary of Probably or Possibly Related TEAEs by SOC, PT And Severity- Stage 2 (Safety Population) 
 
Table 14.3.3.6.1 Summary of TEAEs of Special Interest By SOC, PT And Severity- Stage 1 (Safety Population)  
Table 14.3.3.6.2 Summary of TEAEs of Special Interest By SOC, PT And Severity- Stage 2 (Safety Population)  
Table 14.3.3.7.1 Summary of Serious TEAE By SOC And PT - Stage 1 (Safety Population) 
 
Table 14.3.3.7.2 Summary of Serious TEAE By SOC And PT - Stage 2 (Safety Population) 
 
Table 14.3.3.8.1 Summary of Treatment Related Serious TEAE by SOC And PT - Stage 1 (Safety Population) 
 
Table 14.3.3.8.2 Summary of Treatment Related Serious TEAE by SOC And PT- Stage 2 (Safety Population) 
 
Table 14.3.3.9.1 Summary of TEAE Leading to Study Drug Withdrawal by SOC And PT- Stage 1 (Safety Population) 
 
Table 14.3.3.9.2 Summary of TEAE Leading to Study Drug Withdrawal by SOC And PT- Stage 2 (Safety Population) 
 
Table 14.3.3.10.1 Summary of Treatment Related TEAE Leading to Study Drug Withdrawal by SOC And PT- Stage 1 (Safety Population) 
Table 14.3.3.10.2 Summary of Treatment Related TEAE Leading to Study Drug Withdrawal by SOC And PT- Stage 2 (Safety Population) 
14.3.4. Laboratory Results 
Table 14.3.4.1.1 Summary of Blood Tests- Stage 1 (Safety Population)  
Table 14.3.4.1.2 Summary of Blood Tests- Stage 2 (Safety Population)  
 
Table 14.3.4.2.1 Summary of Blood Tests Shifts from Baseline- Stage 1 (Safety Population) 
 
Table 14.3.4.2.2 Summary of Blood Tests Shifts from Baseline- Stage 2 (Safety Population) 
14.3.5 Other Safety 
 
Table 14.3.5.1.1 Summary of Macroscopic Urinalysis- Stage 1 (Safety Population) 
 
Table 14.3.5.1.2 Summary of Macroscopic Urinalysis- Stage 2 (Safety Population) 
 
Table 14.3.5.2.1 Summary of Vital Signs- Stage 1 (Safety Population) 
 
Table 14.3.5.2.2 Summary of Vital Signs- Stage 2 (Safety Population) 
 
Table 14.3.5.3.1.1 Summary of 12-Lead ECG- Stage 1 (Safety Population) 
 
Table 14.3.5.3.1.2 Summary of 12-Lead ECG- Stage 2 (Safety Population) 
 
Table 14.3.5.3.2.1 Summary of 12-Lead ECG Interpretation- Stage 1 (Safety Population)  
Table 14.3.5.3.2.2 Summary of 12-Lead ECG Interpretation- Stage 2 (Safety Population)  


Protocol Number: CBL-0202 
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Document status:  Addendum 1.0 
 
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Page 48 of 50 
LISTINGS 
 
16.2.1 Subject Disposition 
Listing 16.2.1.1 Analysis Populations (All Subjects) 
 
Listing 16.2.1.2 Participant Disposition (All Subjects) 
Listing 16.2.1.3 Participant Randomization (ITT Population) 
16.2.2 Protocol Deviations 
 
Listing 16.2.2.1 Protocol Deviation (ITT Population) 
16.2.4 Demographic and Other Baseline Data  
Listing 16.2.4.1 Demographics and Baseline Characteristics (ITT Population) 
 
Listing 16.2.4.2 Medical History (ITT Population) 
 
Listing 16.2.4.3 Viral Serology (ITT Population) 
Listing 16.2.4.4 Pregnancy Test (ITT Population) 
 
Listing 16.2.4.5 Follicle Stimulating Hormone (FSH) Test (ITT Population) 
 
Listing 16.2.4.6 Eligibility Criteria (All Subjects) 
 
16.2.5 Treatment Administration 
 
Listing 16.2.5.1 Study Drug Administration (Safety Population)  
16.2.6 Efficacy 
Listing 16.2.6.1 Anthropometric Parameter (ITT Population) 
 
Listing 16.2.6.2 Abdominal Ultrasound (ITT Population) 
Listing 16.2.6.3 Thigh Ultrasound (ITT Population) 
 
16.2.7 Adverse Events 
Listing 16.2.7.1 Adverse Events (Safety Population) 
 
Listing 16.2.7.2 Serious Adverse Events (Safety Population) 
 
Listing 16.2.7.3 Adverse Events Leading to Study Drug Discontinuation (Safety Population) 
 
Listing 16.2.7.4 Adverse Events Leading to Death (Safety Population) 
 
16.2.8 Laboratory Results 
Listing 16.2.8.1 Blood Tests (ITT Population) 
 
Listing 16.2.8.2 Macroscopic Urinalysis (ITT Population) 
 
Listing 16.2.8.3 Urine Microscopy (ITT Population) 
16.2.9 Other Safety 
 
Listing 16.2.9.1 Vital Signs (ITT Population) 
 
Listing 16.2.9.2 12-Lead ECG (ITT Population)  
Listing 16.2.9.3 Physical Examination (ITT Population) 
16.2.10 Prior and Concomitant Medication 
 
Listing 16.2.10.1 Prior Medication (Safety Population)  


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Document status:  Addendum 1.0 
 
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Listing 16.2.10.2 Concomitant Medication (Safety Population) 
 
16.2.11 Other 
Listing 16.2.11.1 General Comments (All Subjects) 
 


Protocol Number: CBL-0202 
 
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Document status:  Addendum 1.0 
 
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Page 50 of 50 
18. 
REFERENCES 
1) 
Clinical Study Protocol Version 8.0 dated 1 March 2023.