A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women
Phase: PHASE2
Conditions: Obesity, Obese, Overweight or Obesity
Sponsor: Eli Lilly and Company

Protocol: J4Z-MC-GIDA 
 
 
A randomized, double-blind, placebo-controlled multi-center study of intravenous bimagrumab, 
alone or in addition to open label subcutaneous semaglutide, to investigate the efficacy and 
safety in overweight or obese men and women 
 
 
NCT05616013 
 
 
Approval Date: 09-Apr-2024 

 
 
 
CLINICAL STUDY PROTOCOL 
Bimagrumab 
VER201-PH2-031 
A randomized, double-blind, placebo-controlled multi-center study 
of intravenous bimagrumab, alone or in addition to open label 
subcutaneous semaglutide, to investigate the efficacy and safety in 
overweight or obese men and women 
 
Confidentiality Statement 
This document is the sole property of Versanis Bio, Inc. This document and all information 
contained herein must be considered and treated as strictly confidential. This document shall be 
used only for the purpose of the disclosure herein provided. No disclosure or publication shall be 
made without the prior written consent of Versanis Bio, Inc. 
 
 
IND Number: 
161031 
EUDRA CT number: 
Not applicable 
Study phase 
2 
Version number: 
5.0 (Amendment 5) 
Sponsor: 
 
Versanis Bio, Inc. 
A wholly owned subsidiary of Eli Lilly and Co. 
1111 Broadway, Suite 1300 
Oakland, CA 94607 
United States 
Approval Date: 
Protocol Electronically Signed and Approved 
by Lilly on date provided below. 
Document ID: 
VV-CLIN-150100 
 
Approved on 09 Apr 2024 GMT

Protocol No. VER201-PH2-031 
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SPONSOR SIGNATURE PAGE  
The protocol has been approved by Versanis Bio, Inc. 
 
 
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Date 
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INVESTIGATOR’S AGREEMENT  
I agree, as an Investigator conducting this study: 
 To assume responsibility for the proper conduct of the study at this site. 
 To conduct the study in compliance with this protocol, with any future amendments, 
and with any other written study conduct procedures provided, reviewed, and 
approved by the Sponsor. 
 Not to implement any deviations from or changes to this protocol without agreement 
from the Sponsor, except where necessary to eliminate an immediate hazard to the 
participants or for administrative aspects of the study (where permitted by all 
applicable regulatory requirements). 
 That I am aware of, and will comply with, Good Clinical Practice and all applicable 
regulatory requirements. 
 To ensure that all persons assisting me with the study are adequately informed about 
the investigational drug and that they are qualified to perform their study-related 
duties and functions, as described in this protocol. 
 That I have been informed that certain regulatory authorities require the Sponsor to 
obtain and supply details about the Qualified Investigator’s ownership interest in the 
Sponsor or the study drug and more generally about his/her financial ties with the 
Sponsor. The Sponsor will obtain and disclose any relevant information in this regard 
solely for the purpose of complying with regulatory requirements. 
Hence, I 
 Agree to supply the Sponsor with all information regarding ownership interest and 
financial ties with the Sponsor (including those of my spouse and dependent 
children); 
 Agree to promptly update this information if any relevant changes occur during the 
study and for 1 year following completion of the study; and 
 Agree that the Sponsor may disclose this information about such ownership interests 
and financial ties to regulatory authorities. 
 
  
 
 
Printed Name of 
Investigator 
 Signature 
of 
Investigator 
 
Date 
Site Name 
 
  
  
Site Address 
  
  
 
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MEDICAL MONITOR NAME AND CONTACT INFORMATION  
Role in Study 
Name 
Email and Telephone Number 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
       
 
       
 
DOCUMENT HISTORY  
DOCUMENT HISTORY 
Document 
Date 
Original (Ver 00) 
14 June 2022 
Amendment 1 (Ver 1.0) 
26 September 2022 
Amendment 1 (Ver 1.1) 
10 October 2022 
Amendment 2 (Ver 2.0)  
19 December 2022 
Amendment 3 (Ver 3.0) 
08 May 2023 
Amendment 4 (Ver 4.0) 
24 September 2023 
 
 
 
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SUMMARY OF CHANGES – FOR AMENDMENT 5, PROTOCOL V. 5.0  
The amendment is considered to be substantial because it is likely to have a significant impact on 
the 
● safety or the rights of the study participants, and 
● reliability and robustness of the data generated in the clinical study. 
Overall Rationale for the Amendment: 
The secondary endpoint has been adjusted to accommodate assessment at Week 72, and new 
exploratory objectives/endpoints have been added to align with the study design. This 
amendment also updates the pre-dose safety lab review at Week 64 to monitor safety. 
Additionally, this amendment provides dosing guidance for management of participants with 
BMI ≤22 kg/m2 and those with perceived excessive body weight loss.  
Section # and Name 
Description of Change 
Brief Rationale 
Section 1.1. Synopsis 
Revised the brief title to read 
as: 
“Safety and efficacy of 
bimagrumab and semaglutide in 
adults who with are overweight 
or obese obesity” 
Prioritizing person-first 
language and avoiding 
stigmatizing adjectives to 
describe individuals living 
with obesity 
Section 1.3. Schedule of 
Activities (SoA) 
Randomization and drug 
administration row: 
 Referenced Footnote “f” for 
Week 64 
 Updated Footnote “f” to 
incorporate pre-dose safety 
lab review at Week 64  
To observe and react to 
potential enzyme elevations 
prior to the second dose of 
bimagrumab in Year 2 at 
Week 64  
Section 1.1. Synopsis 
Section 3. Objectives, 
Endpoints, and Estimands 
 Secondary endpoint: 
Added Week 72 to assess 
treatment effect on waist 
circumference, fat mass, 
VAT, trunk fat mass, SAT, 
lean mass, self-reported 
health status and weight-
related quality of life 
 Secondary objective: 
Added “body composition” 
Alignment with the study 
design to describe Year 2 
endpoints 
Section 3. Objectives, 
Endpoints, and Estimands 
Exploratory objective: 
Added new objective to assess 
the treatment withdrawal effect 
of bimagrumab, semaglutide, 
and bimagrumab in addition to 
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Section # and Name 
Description of Change 
Brief Rationale 
semaglutide on body weight, 
waist circumference, and body 
composition 
Section 3.1. Estimands 
Added information that trial 
product or hypothetical 
estimand will be used to assess 
the primary estimand 
For consistency with SAP 
Section 4.1. Overall Design 
Core Treatment Period (Weeks 
1 to 48): 
 Replaced “participants will 
be required” to “participants 
should” follow 
recommendations for the 
duration of the core 
treatment period 
 Added statement where 
occasional diary misses are 
permissible, provided there 
is no persistent non-
compliance 
Open-Label Extension 
Treatment Period (Weeks 49 to 
72): 
 Replaced “participants 
must” to “participants 
should” continue to follow 
dietary and exercise 
recommendations for the 
duration of the extension 
treatment period 
 Added that participants 
must self-administer weekly 
semaglutide as in the core 
treatment period 
Post-Treatment Follow-Up 
Period (Weeks 73 to 104):  
Replaced “participants must” to 
“participants should” continue 
to follow dietary and exercise 
recommendations 
Clarification 
Section 5.31. Meals and 
Dietary Restrictions 
Indicated that participants must 
fast for at least 8 hours prior to 
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Section # and Name 
Description of Change 
Brief Rationale 
all visits that include blood 
sampling 
Section 5.3.4. Support 
During Treatment 
Withdrawal Period 
Newly added section: 
Added paragraph on 
accessibility to personnel and 
additional resources to aid in 
lifestyle management during the 
treatment withdrawal period 
To +4):1.A$876;7:J;
intentions regarding 
provision of these additional 
healthy lifestyle resources 
during the treatment 
withdrawal period to 
promote participant 
retention 
Section 6.6.2. Semaglutide 
Updated section with 
management of participants 
with C

3/52 and those 
with perceived excessive body 
weight loss 
To be consistent with 
guidance for site 
participants who are losing 
excessive weight 
Section 7.1.1. Liver, 
Pancreas, or Muscle Related 
Events Stopping Criteria 
Added a new timepoint G(--3
Hwhere the p):<1+18)6<J;
safety labs will be reviewed at 
Week 64   
Updated to align with the 
changes made in Section 1.3 
on reviewing safety labs at 
Week 64 
Section 7.1.2. Temporary 
Discontinuation 
Updated the section to reference 
Section 6.6.2 for management 
of participants if they cannot 
tolerate current dose of 
semaglutide 
Updated to align with the 
changes made in Section 
6.6.2 
Section 8. Study 
Assessments and 
Procedures 
Added G
 (Week 64)H as 
an exception to perform dosing 
within the corresponding 
window 
To observe and react to 
potential enzyme elevations 
prior to the second dose of 
bimagrumab at Week 64   
Section 9.4. Treatment 
Extension and Post-
Treatment Follow-Up 
Period Analyses 
 Updated section to include 
analyses and summaries of 
treatment effect at Week 72 
 Deleted language on 
treatment outcome 
comparisons 
To align with the changes 
made in Section 3 to 
describe year 2 endpoints 
Section 10.3.2. Definition 
of SAE 
Other situations bullet: 
,,-,4)6/=)/-<0)<G44
malignancies must be reported 
);$;H 
For clarity 
Section 10.8. Appendix 8: 
Creatine Kinase Safety 
Edits made to Table 11 
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SUMMARY OF CHANGES – FOR AMENDMENT 4, PROTOCOL V. 4.0  
Section # and Name 
Description of Change 
Brief Rationale 
Medical Monitor Name and 
Contact Information 
Replaced Drug Safety 
Physician contact information. 
Eli Lilly Global Patient 
Safety has replaced Parexel 
for Drug Safety Physician 
services. 
Section 1.1 – Synopsis 
Section 1.2 – Study Schema 
Section 4.1 – Overall 
Design 
 
The extension treatment period 
(Weeks 48-72) changed from 
blinded to open label 
The study will be open label 
after Week 48 primary 
efficacy analysis, and 
unblinded after Week 48 
database lock.  Placebo 
injections will continue for 
Arms 2 and 3 until after the 
Week 48 database lock and 
study unblinding.  
Section 1.1 – Synopsis 
Section 3.1.1 – Estimands 
of Secondary Objectives 
Added appendicular lean mass 
by DXA as secondary endpoints 
Lean mass of the arms and 
legs has a higher proportion 
of skeletal muscle than total 
body lean mass.  
Section 1.1 – Synopsis 
Section 3.1.1 – Estimands 
of Secondary Objectives 
Section 9.1 – Statistical 
Analyses 
Removed language referring to 
adjustment for multiplicity. 
Adjustment for multiplicity 
of primary or secondary 
endpoint analyses are no 
longer considered necessary 
by Sponsor, as study results 
will be used primarily for 
further development 
planning purposes. 
Section 1.1 – Synopsis 
 
Allowed for the addition of two 
non-voting members from the 
Sponsor (who are not part of the 
study team) to the DMC. 
The DMC has requested 
additional support from the 
Sponsor by adding two non-
voting members with safety 
and statistical expertise. 
Section 1.3 – Schedule of 
Activities (SoA) 
Removed Week 104 blood 
draws for PD biomarkers and 
anti-drug antibodies. 
Follow up blood collection 
at Week 96 is sufficient for 
these parameters. 
Section 3 – Objectives, 
Endpoints, and Estimands 
Section 8.2.6.2 – Glucose 
Metabolism Parameters: 
HbA1c, Fasting Insulin and 
Glucose 
Replaced HOMA2-IR with 
HOMA-IR . 
HOMA2-IR is proprietary 
and unavailable; HOMR-IR 
is a suitable alternative. 
Section 5.3.1 – Meals and 
Dietary Restrictions 
Guidance provided for cases 
where participant reaches a 
BMI ≤ 22 kg/m2. 
Guidance provided for 
safety of participants losing 
excessive weight. 
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Section # and Name 
Description of Change 
Brief Rationale 
Section 9.3 – Interim 
Analysis 
Added interim analysis. 
A 24-week interim analysis 
was added for internal 
decision-making purposes 
Section 10.7 – APPENDIX 
7: Lipase and Amylase 
Safety 
Allowed for the addition of an 
adjudication committee for 
acute pancreatitis and other 
major adverse events. 
The DMC has requested 
additional support for 
evaluating suspected cases 
of pancreatitis. 
Additional changes include grammatical corrections and clarifying text. 
 
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SUMMARY OF CHANGES # FOR AMENDMENT 3, PROTOCOL V. 3.0  
Section # and Name 
Description of Change 
Brief Rationale 
Section 1.1 F Synopsis 
Table 1 F Table of 
Objectives and Endpoints 
Section 9.1 Statistical 
Analyses 
Rephrased primary endpoint, 
secondary objectives, and 
secondary endpoints to measure 
)I+0)6/-J:)<0-:<0)6specify 
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change. 
Allow the Statistical 
Analysis Plan to be the 
source of detail for all 
planned analyses. 
Section 1.1 F Synopsis 
Table 1 F Table of 
Objectives and Endpoints 
Section 8.2.2 F DXA Scan 
Added assessment of treatment 
effects on subcutaneous adipose 
tissue to secondary objectives 
and secondary endpoints.  Also 
included an analysis of decrease 
in body weight >15%. 
More completely 
characterize treatment 
effects. 
Section 1.1 F Synopsis 
Section 1.2 F Study Schema 
Section 1.3 F Schedule of 
Activities 
Section 4.1 F Overall 
Design 
Section 4.2 F Scientific 
Rationale for Study Design 
Section 4.3.1 F 
Bimagrumab Doses 
Section 6.1 F Study 
Intervention Administered 
Section 6.7 F Continued 
Access to Study 
Intervention after the End of 
Treatment 
Section 7.1 F Participant 
Discontinuation of Study 
Intervention 
Section 7.2 F Participant 
Discontinuation/Withdrawal 
from the Study 
Revised study design to add a 
24-week treatment extension 
period and a 32-week post-
treatment follow-up period. 
During the treatment extension, 
participants in Arms 1 and 4 
will have blinded treatment 
modified to 30 mg/kg 
bimagrumab. 
Compare the results of 
bimagrumab and/or 
semaglutide treatment for 
continued weight loss and 
fat mass reduction in the 2nd 
year of treatment, as well as 
in maintenance of weight 
loss and composition of 
weight regain, if any. 
Allow participants on 
placebo or low dose 
bimagrumab in the 1st year 
to receive high dose 
bimagrumab during the 2nd 
year. 
Section 1.1 F Synopsis 
Section 4.1 - Overall 
Design 
Section 5 F Study 
Population 
Section 6.3 F Assignment to 
Study Intervention 
Section 6.4.2 F Semaglutide 
 
 
 
 
Based on revised sample 
size calculation in 
accordance with revised 
endpoints; also, to account 
for the increased number of 
expected participant 
withdrawals due to the 
extended duration of study. 
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Section # and Name 
Description of Change 
Brief Rationale 
Section 9.5 – Sample Size 
Determination 
Section 1.1 – Synopsis  
Section 3.1 – Estimands 
Section 9.1 Statistical 
Analyses 
Section 9.4 – Treatment 
Extension and Post-
Treatment Follow-up Period 
Analyses 
Section 9.5 – Sample Size 
Determination 
Updated statistical analysis 
plans, including: 
 Revised the sample size 
determination; 
 Identifying Week 48 as the 
point of primary efficacy 
analysis; 
 Added analyses for the 
treatment extension and 
follow-up periods 
Provide an overview of the 
statistical plan for the 
revised study design. 
Section 1.1 – Synopsis 
Section 3.1 – Estimands 
Section 9.1 Statistical 
Analyses 
‘Intention-to-treat’ population 
redefined to include only 
randomized participants who 
received at least one dose of 
study medication. 
Remove from primary 
analysis participants who 
randomize into a treatment 
arm but did not receive 
treatment. 
Section 1.3 – Schedule of 
Activities 
Section 4.1 – Overall 
Design 
Section 7.1 – Participant 
Discontinuation of Study 
Intervention 
Section 7.2 – Participant 
Discontinuation/Withdrawal 
from the Study 
For participants permanently 
discontinuing study intervention 
early, change the required 
timeframe for conduct of an 
End of Study visit from 8 weeks 
to 12 weeks after last dose of 
bimagrumab/placebo. 
Evaluate the participant for 
safety after the 
bimagrumab/placebo is 
expected to have been 
eliminated. 
Section 4.1 – Overall 
Design 
Section 5.4 – Screen 
Failures 
Section 8 – Study 
Assessments and 
Procedures 
Section 8.5 – 
Pharmacokinetics 
Assessment windows added or 
clarified as follows: 
 Screening window revised 
to allow 1 repeat of any 
assessment that falls outside 
of Week -6 to Day -1; 
 Added a window for Week 
4 dosing; 
 Added a window for 
collection of post-dose 
bimagrumab PK samples. 
Prevent the exclusion of 
otherwise eligible 
participants based solely on 
timing of assessments in 
relation to dosing. 
 
Clarify allowable windows 
for select assessments. 
Section 4.1 – Overall 
Design 
Specify the requirement for 
dietary intake evaluation via 24-
hour recall assessments at 
monthly dietician outreach.  
Clarify the required 
assessments to be conducted 
and data collected during 
the dietary consultations. 
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Section # and Name 
Description of Change 
Brief Rationale 
Section 4.2 – Scientific 
Rationale for Study Design 
Section 9.1 Statistical 
Analyses 
FDA guidance for primary 
efficacy endpoints in phase 2 
trials was added. 
Clarify the FDA’s 
recommendations regarding 
the study’s primary 
endpoint. 
Section 5.2 – Exclusion 
Criteria 
Exclusion Criteria refined: 
 #18 specifies medication 
associated with severe 
pancreatitis, such as 
valproate 
 #20 replaces BUN exclusion 
with serum creatine >1.5x 
ULN 
Prevent concomitant 
medications from 
contributing to an increased 
risk of on-study 
pancreatitis. 
 
More closely align the 
measure of impaired renal 
function with clinical 
practice. 
Section 5.3.1 – Meals and 
Dietary Restrictions 
Added provision for alteration 
of on-study dietary restrictions 
if healthy weight status is 
achieved. 
Allow standard clinical 
practice in dietary 
counseling for study 
participants who achieve a 
healthy weight. 
Section 5.4 – Screen 
Failures 
Clarification of screen failures 
to include participants who 
choose to not proceed to enroll. 
Account for the fact that 
participants otherwise 
eligible may be categorized 
as screen failures if they 
chose to withdraw consent 
prior to dosing. 
Section 6.4 – Blinding 
Clarified that blinding will 
remain intact at least until 
database is locked for the core 
and extension treatment 
periods. 
Specify the duration of 
study blind as a result of the 
study extension.  The 
primary analysis remains at 
Week 48, which is now 
mid-way through the study 
instead of at the conclusion. 
Section 6.6.1 – 
Bimagrumab 
Bimagrumab dosing 
modification may be allowed 
for safety reasons. 
Removed incongruity 
between this section and the 
guidance provided in 
Appendices 6, 7, and 8. 
Section 6.9.1 – Prohibited 
Medicine 
Prohibited medications and 
recommended actions refined: 
 
Hormone replacement therapy 
in women addressed; 
 
Allow short term courses of 
glucocorticoids; 
 
Require Medical Monitor 
consultation for medications 
that may cause weight change; 
Refined the prohibition of 
medications based on their 
situational potential to 
significantly impact safety 
or efficacy. 
 
Prevent valproate from 
contributing to the risk of 
on-study pancreatitis. 
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Section # and Name 
Description of Change 
Brief Rationale 
 
Prohibit the use of valproate. 
Section 7.1.1 F Liver, 
Pancreas, or Muscle Related 
Events Stopping Criteria 
Section 7.1.2 F Temporary 
Discontinuation 
Section 8.3.4 F Clinical 
Safety Laboratory Tests 
Section 10.7 F APPENDIX 
7: Lipase and Amylase 
Safety 
Section 10.8 F APPENDIX 
8: Creatine Kinase Safety 
Provided greater specificity in 
the guidance for study treatment 
interruption and/or 
discontinuation as a result of 
liver, pancreas, or muscle 
related events, including a 
requirement to review lab 
results at Week 4 prior to 
administering 
bimagrumab/placebo dose. 
Provide Investigators with 
more detailed guidance on 
how to assure the safety of 
participants experiencing 
one of these events. 
Section 7.4 F Treatment 
Arm and Study 
Stopping/Pausing Rules 
Specified that SAEs of a similar 
type must be related to blinded 
treatment to qualify as part of 
the study stopping/pausing 
rules; expected SAEs do not 
qualify. 
Ensure that SAEs related to 
semaglutide and those that 
are expected per the 
bimagrumab Reference 
Safety Information do not 
contribute to study stopping 
or pausing. 
Section 8.1F Administrative 
Procedures 
Specified data collection needs 
related to obesity history and 
obesity-related comorbidities. 
Provide additional detail 
regarding key obesity-
related data collection. 
Section 8.4.5 F Treatment 
Emergent Adverse Events 
of Special Interest 
Section 10.6 F Liver Safety 
Section 10.7 F Lipase and 
Amylase Safety 
Section 10.8 F Creatine 
Kinase Safety 
Revised the list of AESIs. 
Definition of AESIs was 
revised; monitoring of 
laboratory test 
abnormalities is outlined in 
Appendices. 
Section 8.6.1 F PD 
Biomarkers  
Section 10.2 F APPENDIX 
2: Clinical Laboratory Tests 
 
 
To allow further analysis of 
bone biomarkers. 
Section 10.2 F APPENDIX 
2: Clinical Laboratory Tests 
Clarified laboratory tests: 
 
Screening only tests 
performed locally to include 
TSH and remove HBsAb and 
HBcAb 
 
Added anti-drug antibodies 
Clarify/align tests being 
performed at screening with 
the Schedule of 
Assessments and Appendix 
2. 
Additional changes include grammatical and clarifying text as well as revisions to reflect the 
extended treatment period. 
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SUMMARY OF CHANGES # FOR AMENDMENT 2, PROTOCOL V. 2.0  
Section # and Name 
Description of Change 
Brief Rationale 
Section 1.1 F Synopsis 
Section 2.1 F Study 
Rationale 
Section 2.3.2.1 - 
Bimagrumab 
Section 3.0 F Objectives, 
Section 9 F Statistical 
Considerations 
Revised primary endpoint from 
waist circumference to body 
weight and reordered secondary 
objectives and endpoints. 
Revised in response to FDA 
feedback. 
Section 1.1 F Synopsis 
Section 10.1.6 F Data Safety 
Committee 
Revised timing of the first DMC 
meeting from 30 to 
days after 
the first 
% of participants have 
completed dosing. 
The 2 week delay will allow 
for collection of safety data 
from the 0.5 mg semaglutide 
+ bimagrumab treatment 
arms. 
Section 1.1 -  Synopsis 
 
Added clarification on approved 
dosage substitution for 
semaglutide. 
Due to uncertain availability 
of semaglutide dosage forms, 
accepted dose levels for dose 
escalation are indicated. 
Section 1.1 - Synopsis 
Section 5.1 - Inclusion 
Criteria 
Section 5.3.3 - Other 
restrictions 
Section 10.4 - Appendix 4: 
Contraceptive Guidance 
Clarified the criterion to have an 
IUD in place from 3 months prior 
to the baseline visit and not the 
screening visit. Additionally, 
clarified the use of a barrier for 
these participants starts from the 
screening visit and last up to 4 
months after the last dose of 
bimagrumab/placebo. 
The revised timeframe is 
deemed to be sufficient to 
ensure there are no safety 
issues with the placement of 
the IUD. 
Section 1.1 F Synopsis 
Section 5.2 -  Exclusion 
Criteria 
Key Exclusion Criteria F clarified 
exclusion of subjects with 
diabetes 
Diabetic subjects on 
antidiabetic drug or with 
*	+D?144*-
excluded for this study of 
non-diabetic obesity. 
Section 3.1 FEstimands 
Estimand section revised based 
on the primary endpoint of body 
weight using the treatment policy 
strategy which include all 
subjects without relevance to 
intercurrent events. 
Section edited to match the 
revised primary endpoint. 
Section 1.3 - Schedule of 
Activities (SoA) 
,,-,):7?.7:G)A;H)6,
corrected the table header at week 
36 to read P12. 
Editorial/clarification 
change. 
Section 1.3 - Schedule of 
Activities (SoA) 
Added optional future use of 
samples informed consent as an 
assessment 
Added for clarity. 
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Section # and Name 
Description of Change 
Brief Rationale 
Section 2.3.1.1 - 
Investigational Intervention 
Bimagrumab 
Added potential risk of disruption 
of menstrual cycles in 
premenopausal women with an 
IUD implant, due to decreased 
FSH levels. 
Risk language in response to 
FDA feedback. 
Section 4.1 - Baseline 
Section 8.0 - Study 
Assessment and Procedures 
Revised baseline window for 
DXA from 7 days prior to the 
baseline visit to 14 calendar days 
prior to the baseline visit. Non-
baseline DXA windows revised to 
be  -2 weeks to +1 week of the 
scheduled time for all other visits. 
The flexibility of the week 4 
dosing visit was removed. 
Based on site feedback, DXA 
assessment window extended 
to allow sufficient time for 
DXA scans to be scheduled 
around study visits. 
Section 4.1 -Baseline 
Clarified that baseline 
assessments should be completed 
at least 15 minutes prior to 
dosing. 
Editorial/clarification 
change. 
Section 8.4.1 – Time Period 
for Collecting AEs 
Non-serious AEs will be collected 
after first dose of study 
medication(s) instead of after 
screening. 
To avoid incomplete entry of 
medical history, medical 
conditions identified during 
the screening period will be 
captured as medical history. 
Section 8.4.4 – Pregnancy 
Pregnancies in female partners of 
male participants will be reported. 
Outcomes of pregnancies in 
female participants as well as 
female partners of male 
participants will be recorded. 
Section 9.3 – Interim 
Analysis 
Removed the plan for an interim 
analysis. 
Due to the expected rate of 
recruitment, an interim 
analysis is no longer required 
for development planning. 
Section 10.2 – Clinical 
Laboratory Tests 
HCV RNA removed from the 
screening tests 
HCVAb will be used to 
detect hepatitis C infection; 
HCV RNA may be used to 
confirm active infection. 
Additional changes include grammatical and clarifying text as well as revisions to reflect the 
extended treatment period. 
SUMMARY OF CHANGES – FOR AMENDMENT 1.1, PROTOCOL V. 1.1  
Section # and Name 
Description of Change 
Brief Rationale 
Table of contents 
Administrative 
Table of Contents updated 
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SUMMARY OF CHANGES – FOR AMENDMENT 1, PROTOCOL V. 1.0  
Section # and Name 
Description of Change 
Brief Rationale 
1.0 Synopsis 
1.2 Study Schema 
1.3 Schedule of Activities 
1.4 Study Design 
Study duration increased from 
28 weeks to 48 weeks. 
Corresponding additions to 
assessments:  
 
Phone calls at Weeks 32, 36 
and 44; on-site visits at Weeks 
40 and 48. 
 
Dosing events at Weeks 28 
and 40. 
 
DXA at Week 48 
 
Safety/efficacy assessments at 
Weeks 40 and 48 
Dosing through week 48 with 
placebo control will showcase 
greater effect of bimagrumab 
and combinations with  
semaglutide across multiple 
measures of efficacy. 
1.0 Synopsis 
3.0 Objectives, Endpoints 
and Estimands 
9.0 Statistical 
Considerations 
Changes in objectives and 
endpoints related to the 
increased duration of the study 
and the change in the lower dose 
of the semaglutide treatment 
arms. 
Changes were required to 
harmonize with the study design. 
1.0 Synopsis 
4. Study Design 
5. Study Population 
2.2.2 Teratogenicity and 
Reproductive Toxicity Data 
Age limit of 40+ years for 
females lowered to 18+ who are 
post-menopausal or post-
surgically sterilized or have in 
place an IUD and are willing to 
use a form of barrier 
contraception 
Expanded age range may 
provide exposure, safety and 
efficacy data in the 18-40 age 
range for females, more 
reflective of the intended Phase 
3 study population, as 
recommended by FDA. 
4.2 Scientific Rationale for 
Study Design 
4.3 Justification for Dose 
6.1 Study interventions 
Administered 
6.6 Dose Modification 
9.1 Statistical Analysis 
Semaglutide low dose increased 
from 0.5 mg to 1 mg 
Longer dosing period (through 
week 48) allows for adequate 
titration and exploration of an 
approved dose of semaglutide 
(Wegovy®, Ozempic®). 
1.0 Synopsis 
5.1 Inclusion Criteria 
5.2 Exclusion Criteria 
 
Refined inclusion criterion: 
 
Stable body weight as +/-5 kg 
 
Diagnosis of diabetes includes 
HbA1c ≥ 6.5% 
Clarified information previously 
in both inclusion and exclusion 
criteria 
1.0 Synopsis 
9.4 Sample Size 
Determination 
Modified sample size 
calculations  
Longer duration of study allows 
for power calculation based on 
larger expected treatment 
difference vs placebo, 
anticipated dropout rate, and 
multiple endpoint testing. 
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9.3 Interim Analysis 
Interim Analysis (group 
unblinding only) added at Week 
24 
Provides limited, group 
unblinded data readout to 
facilitate clinical development 
program planning. 
 
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TABLE OF CONTENTS 
SPONSOR SIGNATURE PAGE ....................................................................................................2 
INVESTIGATOR’S AGREEMENT ...............................................................................................3 
MEDICAL MONITOR NAME AND CONTACT INFORMATION ............................................4 
DOCUMENT HISTORY.................................................................................................................4 
SUMMARY OF CHANGES – FOR AMENDMENT 5, PROTOCOL V. 5.0 ...............................5 
SUMMARY OF CHANGES – FOR AMENDMENT 4, PROTOCOL V. 4.0 ...............................8 
SUMMARY OF CHANGES – FOR AMENDMENT 3, PROTOCOL V. 3.0 .............................10 
SUMMARY OF CHANGES – FOR AMENDMENT 2, PROTOCOL V. 2.0 .............................14 
SUMMARY OF CHANGES – FOR AMENDMENT 1.1, PROTOCOL V. 1.1 ..........................15 
SUMMARY OF CHANGES – FOR AMENDMENT 1, PROTOCOL V. 1.0 .............................16 
TABLE OF CONTENTS ...............................................................................................................18 
LIST OF TABLES .........................................................................................................................23 
LIST OF ABBREVIATIONS ........................................................................................................24 
1. 
PROTOCOL SUMMARY ..........................................................................................28 
1.1. 
Synopsis ......................................................................................................................28 
1.2. 
Study Schema .............................................................................................................34 
1.3. 
Schedule of Activities (SoA) ......................................................................................35 
2. 
INTRODUCTION ......................................................................................................40 
2.1. 
Study Rationale ...........................................................................................................40 
2.2. 
Background .................................................................................................................41 
2.2.1. 
Preclinical Pharmacology ...........................................................................................42 
2.2.2. 
Clinical Data ...............................................................................................................43 
2.3. 
Benefit/Risk Assessment ............................................................................................44 
2.3.1. 
Risk Assessment .........................................................................................................44 
2.3.1.1. 
Investigational Intervention Bimagrumab ..................................................................44 
2.3.1.2. 
Semaglutide (Wegovy®, Ozempic®) .........................................................................46 
2.3.1.3. 
Study Procedures ........................................................................................................48 
2.3.2. 
Benefit Assessment .....................................................................................................49 
2.3.2.1. 
Bimagrumab ...............................................................................................................49 
2.3.2.2. 
Semaglutide ................................................................................................................49 
2.3.3. 
Overall Benefit Risk Conclusion ................................................................................49 
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3. 
OBJECTIVES, ENDPOINTS, AND ESTIMANDS ..................................................50 
3.1. 
Estimands ....................................................................................................................52 
3.1.1. 
Estimands of Secondary Objectives ...........................................................................52 
4. 
STUDY DESIGN .......................................................................................................54 
4.1. 
Overall Design ............................................................................................................54 
4.2. 
Scientific Rationale for Study Design ........................................................................57 
4.3. 
Justification for Dose ..................................................................................................58 
4.3.1. 
Bimagrumab Doses .....................................................................................................58 
4.3.2. 
Semaglutide Doses ......................................................................................................59 
4.4. 
End-of-Study Definition .............................................................................................59 
5. 
STUDY POPULATION .............................................................................................59 
5.1. 
Inclusion Criteria ........................................................................................................60 
5.2. 
Exclusion Criteria .......................................................................................................60 
5.3. 
Lifestyle Considerations .............................................................................................63 
5.3.1. 
Meals and Dietary Restrictions ...................................................................................63 
5.3.2. 
Activity .......................................................................................................................64 
5.3.3. 
Other Restrictions .......................................................................................................64 
5.3.4. 
Support During Treatment Withdrawal Period ...........................................................64 
5.4. 
Screen Failures ............................................................................................................64 
6. 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ........................64 
6.1. 
Study Interventions Administered ..............................................................................66 
6.2. 
Preparation, Handling, Storage, and Accountability ..................................................68 
6.3. 
Assignment to Study Intervention ..............................................................................68 
6.4. 
Blinding ......................................................................................................................69 
6.4.1. 
Bimagrumab and Placebo ...........................................................................................69 
6.4.2. 
Semaglutide ................................................................................................................69 
6.4.3. 
SAE and Unblinding ...................................................................................................69 
6.4.4. 
Unblinded Personnel ...................................................................................................69 
6.5. 
Study Intervention Compliance ..................................................................................70 
6.6. 
Dose Modification ......................................................................................................70 
6.6.1. 
Bimagrumab ...............................................................................................................70 
6.6.2. 
Semaglutide ................................................................................................................70 
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6.7. 
Continued Access to Study Intervention after the End of Treatment .........................71 
6.8. 
Treatment of Overdose ...............................................................................................71 
6.8.1. 
Bimagrumab ...............................................................................................................71 
6.8.2. 
Semaglutide ................................................................................................................71 
6.9. 
Prior and Concomitant Therapy ..................................................................................71 
6.9.1. 
Prohibited Medicine ....................................................................................................72 
6.9.2. 
Prohibited Non-Pharmacological Concomitant Treatments .......................................73 
6.9.3. 
Recommended Treatment of Adverse Events ............................................................73 
7. 
DISCONTINUATION OF STUDY INTERVENTION, PARTICIPANT 
DISCONTINUATION / WITHDRAWAL AND STUDY STOPPING / 
PAUSING ...................................................................................................................73 
7.1. 
Participant Discontinuation of Study Intervention .....................................................73 
7.1.1. 
Liver, Pancreas, or Muscle Related Events Stopping Criteria ....................................74 
7.1.2. 
Temporary Discontinuation ........................................................................................74 
7.2. 
Participant Discontinuation/Withdrawal from the Study ...........................................74 
7.3. 
Lost to Follow-up .......................................................................................................75 
7.4. 
Treatment Arm and Study Stopping/Pausing Rules ...................................................75 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................76 
8.1. 
Administrative Procedures ..........................................................................................76 
8.2. 
Efficacy / Pharmacodynamics Assessments ...............................................................77 
8.2.1. 
Anthropometric Measurements ..................................................................................77 
8.2.1.1. 
Body Weight ...............................................................................................................77 
8.2.1.2. 
Waist Circumference ..................................................................................................77 
8.2.1.3. 
Body Mass Index ........................................................................................................77 
8.2.1.4. 
Bioelectrical Impedance Analysis ..............................................................................77 
8.2.2. 
DXA Scan ...................................................................................................................78 
8.2.4. 
Impact of Weight on Quality of Life-Lite Clinical Trials Version .............................78 
8.2.5. 
Short Form (SF-36) Health Survey .............................................................................78 
8.2.6. 
Physical Activity Monitoring Via 
 ............................................................78 
8.2.6.1. 
Lipid Profile ................................................................................................................78 
8.2.6.2. 
Glucose Metabolism Parameters: HbA1c, Fasting Insulin and Glucose ....................79 
8.3. 
Safety Assessments .....................................................................................................79 
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8.3.1. 
Physical Examinations ................................................................................................79 
8.3.2. 
Vital Signs ..................................................................................................................79 
8.3.3. 
Electrocardiograms .....................................................................................................80 
8.3.4. 
Clinical Safety Laboratory Tests ................................................................................80 
8.3.5. 
Pregnancy Testing ......................................................................................................81 
8.3.6. 
Hematology/Coagulation ............................................................................................81 
8.3.7. 
Blood Chemistry .........................................................................................................81 
8.3.8. 
Urinalysis and Urine Chemistry .................................................................................81 
8.4. 
Adverse Events, Treatment Emergent Adverse Events, Serious Adverse 
Events, and Other Safety Reporting ...........................................................................81 
8.4.1. 
Time Period and Frequency for Collecting AE, TEAE and SAE Information ..........82 
8.4.2. 
Follow-up of AEs and SAEs .......................................................................................82 
8.4.3. 
Regulatory Reporting Requirements for SAEs ...........................................................82 
8.4.4. 
Pregnancy ...................................................................................................................83 
8.4.5. 
Treatment Emergent Adverse Events of Special Interest ...........................................83 
8.5. 
Pharmacokinetics ........................................................................................................83 
8.6. 
Pharmacodynamics .....................................................................................................84 
8.7. 
Genetics ......................................................................................................................84 
8.8. 
Immunogenicity Assessments ....................................................................................85 
9. 
STATISTICAL CONSIDERATIONS .......................................................................85 
9.1. 
Statistical Analyses .....................................................................................................85 
9.1.1. 
Multiplicity Adjustment..............................................................................................86 
9.2. 
Analysis Sets ...............................................................................................................86 
9.3. 
Interim Analysis ..........................................................................................................87 
9.4. 
Treatment Extension and Post-Treatment Follow-Up Period Analyses .....................87 
9.5. 
Sample Size Determination ........................................................................................87 
10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................88 
10.1. 
APPENDIX 1: Regulatory, Ethical, and Study Oversight Considerations ................88 
10.1.1. 
Regulatory and Ethical Considerations ......................................................................88 
10.1.2. 
Financial Disclosure ...................................................................................................88 
10.1.3. 
Informed Consent Process ..........................................................................................89 
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10.1.4. 
Recruitment Strategy ..................................................................................................89 
10.1.5. 
Data Protection ...........................................................................................................89 
10.1.5.1. 
Future Use of Stored Specimens and Data .................................................................89 
10.1.6. 
Data Safety Committee ...............................................................................................90 
10.1.7. 
Site Monitoring ...........................................................................................................91 
10.1.8. 
Clinical Monitoring ....................................................................................................91 
10.1.9. 
Audits and Inspections ................................................................................................92 
10.1.10. 
Data Quality Assurance ..............................................................................................92 
10.1.11. 
Data Handling and Recordkeeping .............................................................................94 
10.1.12. 
Study and Site Start and Closure ................................................................................95 
10.1.13. 
Publication Policy .......................................................................................................95 
10.2. 
APPENDIX 2: Clinical Laboratory Tests ...................................................................96 
10.3. 
APPENDIX 3: AEs and SAEs: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ......................................................................100 
10.3.1. 
Definition of AE .......................................................................................................100 
10.3.2. 
Definition of SAE .....................................................................................................101 
10.3.3. 
Recording and Follow-Up of AE and/or SAE ..........................................................102 
10.3.4. 
Reporting of SAEs ....................................................................................................103 
10.4. 
APPENDIX 4: Contraceptive Guidance ...................................................................105 
10.5. 
APPENDIX 5: Genetics ...........................................................................................106 
10.5.1. 
Optional Consent ......................................................................................................106 
10.5.2. 
Use/Analysis of DNA ...............................................................................................106 
10.5.3. 
Storage of Genetic Samples ......................................................................................106 
10.6. 
APPENDIX 6: Liver Safety: Suggested Actions and Follow-up Assessments ........107 
10.7. 
APPENDIX 7: Lipase and Amylase Safety ..............................................................109 
10.8. 
APPENDIX 8: Creatine Kinase Safety .....................................................................110 
11. 
REFERENCES .........................................................................................................111 
 
 
 
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LIST OF TABLES  
Table 1: 
Table of Objectives and Endpoints .............................................................................50 
Table 2: 
Study Interventions Administered ..............................................................................66 
Table 3: 
Study Treatment Arms ................................................................................................67 
Table 4: 
Prohibited Medications ...............................................................................................72 
Table 5: 
Safety Laboratory Tests ..............................................................................................96 
Table 6: 
Other Laboratory Tests (Central Lab) ........................................................................98 
Table 7: 
Liver Event and Laboratory Trigger Definitions ......................................................107 
Table 8: 
Actions Required for Liver Events and Laboratory Triggers ...................................107 
Table 9: 
Follow Up Requirements for Liver Laboratory Triggers - Isolated 
Hyperbilirubinemia ...................................................................................................108 
Table 10: Safety Monitoring Guidance for Amylase and Lipase Elevations ...........................109 
Table 11: Safety Monitoring Guidance for Creatine Kinase Elevations ..................................110 
 
 
 
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LIST OF ABBREVIATIONS  
Abbreviation or Specialist Term 
Explanation 
ActRII 
Activin Receptor Type II 
ActRIIA 
Activin Receptor Type II A 
ActRIIB 
Activin Receptor Type II B  
ADA 
Anti-Drug-Antibodies 
AE 
Adverse Event 
AESI 
Adverse Events of Special Interest 
ALT 
Alanine Aminotransferase 
ALP 
Alkaline Phosphate 
AST 
Aspartate Aminotransferase 
aPTT 
Activated Partial Thromboplastin Time 
AUC 
Area Under the Curve 
BIA 
Biomolecular Interaction Analysis 
BMD 
Bone Mineral Density 
BMI 
Body Mass Index 
bpm 
Beats Per Minute 
BSAP 
Bone Specific Alkaline Phosphatase 
CBC 
Complete Blood Count 
CIOMS 
Council For International Organizations of Medical Sciences 
CCK18 
Caspase-Cleaved K18 
CK 
Creatine Kinase 
CL 
Clearance 
Cmax  
Maximum or Peak Concentration 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CTC(AE) 
Common Terminology Criteria (For Adverse Events) 
CTX 
C-terminal telopeptide 
DMC 
Data Monitoring Committee 
DNA 
Deoxyribonucleic Acid 
DXA 
Dual-Energy X-Ray Absorptiometry 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
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Abbreviation or Specialist Term 
Explanation 
EOS 
End of Study 
FAS 
Full Analysis Set 
FBM 
Fat Body Mass 
FFM 
Fat-Free Mass 
FSH 
Follicle Stimulating Hormone 
GDF11 
Growth Differentiation Factor 11 
GCP 
Good Clinical Practice 
GGT 
Gamma-Glutamyl Transferase 
GLP1 
Glucagon-Like Peptide-1 
HbA1c 
Hemoglobin A1C 
HBV 
Hepatitis B Virus 
HCV 
Hepatitis C Virus 
HDL 
High Density Lipoprotein 
HIV 
Human Immunodeficiency Virus 
HOMA2 
Homeostasis Model Assessment, version 2 
hsCRP 
High-sensitivity C-reactive protein 
IA 
Interim Analysis 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonization 
ICE 
Intercurrent Event 
IEC 
Independent Ethics Committees 
IL-6 
Interleukin 6 
IL-18 
Interleukin 18 
IgG 
Immunoglobulin G 
IMP 
Investigational Medicinal Product 
INR 
International Normalized Ratio 
IRB 
Institutional Review Boards 
ITT 
Intention to Treat 
IUD 
Intrauterine Device 
i.v. 
Intravenous 
IWQOL-Lite-CT 
Impact of Weight on Quality of Life-Lite Clinical Trials 
IWRS 
Interactive Web Response Systems 
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Abbreviation or Specialist Term 
Explanation 
LBM 
Lean Body Mass 
LDH 
Lactate Dehydrogenase 
LDL 
Low Density Lipoprotein 
miR-122 
MircoRNA 122 
MRI 
Magnetic Resonance Imaging 
MTC 
Medullary Thyroid Carcinoma 
NGAL 
Neutrophil gelatinase-associated lipocalin 
NOAEL 
No Observed Adverse Event Level 
PD 
Pharmacodynamic(s) 
PI 
Package Insert 
PK 
Pharmacokinetic(s) 
PoC 
Proof of Concept 
PT 
Prothrombin Time 
QOL 
Quality of Life 
QTc 
Corrected QT Interval 
QUICKI 
Quantitative Insulin-Sensitivity Check Index 
SAE 
Serious Adverse Event 
SAF 
Safety Analysis Set 
SAP 
Statistical Analysis Plan 
SAT 
Subcutaneous Adipose Tissue 
SF-36 
Short Form 36 Health Survey Questionnaire 
SGLT2 
Sodium-glucose Cotransporter-2 
sIBM 
Sporadic Inclusion Body Myositis 
s.c. 
Subcutaneous 
SD 
Standard Deviation 
SGOT 
Serum Glutamic-Oxaloacetic Transaminase 
SGPT 
Serum Glutamate Pyruvate Transaminase 
SoA 
Schedule of Activities 
SOM 
Study Operations Manual  
SUSAR 
Suspected Unexpected Serious Adverse Reactions 
T2DM 
Type 2 Diabetes Mellitus 
TBW 
Total Body Water 
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Abbreviation or Specialist Term 
Explanation 
TC 
Total Cholesterol 
TG 
Triglyceride 
TEAE 
Treatment Emergent Adverse Event  
TGF-β 
Transforming Growth Factor Beta 
ULN 
Upper Limit of Normal 
VAT 
Visceral Adipose Tissue 
WC 
Waist Circumference 
 
 
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1. 
PROTOCOL SUMMARY  
1.1. 
Synopsis  
Sponsor/Company 
Versanis Bio, Inc. 
Investigational 
Product 
Bimagrumab 
Protocol Number 
VER201-PH2-031 
Title 
A randomized, double-blind, placebo-controlled study of intravenous 
bimagrumab, alone or in addition to open label subcutaneous semaglutide to 
investigate the efficacy and safety in overweight or obese men and women 
Brief Title 
Safety and efficacy of bimagrumab and semaglutide in adults with 
overweight or obesity 
Study Phase 
2 
Study Type 
Interventional 
Rationale 
Most weight loss programs, including obesity pharmacotherapy, reduce body 
weight; however, this often occurs at the expense of lean mass. Bimagrumab 
has been shown to reduce fat mass accompanied by an increase in muscle 
mass. This study investigates if bimagrumab, alone or in addition to standard 
of care semaglutide, can preserve/increase muscle mass in the presence of 
weight and fat mass loss. 
Primary Objective 
1. To assess treatment effect of bimagrumab, semaglutide, and bimagrumab 
in addition to semaglutide vs placebo on body weight 
Secondary Objectives 1. To assess the treatment effect of bimagrumab, semaglutide, and 
bimagrumab in addition to semaglutide vs placebo on waist 
circumference (WC, cm) 
2. To assess treatment effects on fat mass, visceral adipose tissue (VAT), 
trunk fat mass, subcutaneous adipose tissue (SAT), and lean mass (body 
composition) 
3. To assess the safety and tolerability of bimagrumab, semaglutide and 
bimagrumab in addition to semaglutide 
4. To assess the proportion of patients in each treatment group experiencing 
a change in the categorical classification of obesity based on BMI and 
waist-to-height ratio (WHtR) group 
5. To assess treatment effects on glucose metabolism 
6. To assess treatment effects on self-reported health status and weight-
related quality of life 
Primary Endpoint 
1. Change from baseline in total body weight at 48 weeks  
Secondary Endpoints 
1. Change from baseline in WC (cm) at 48 and 72 weeks 
2. a.  Change from baseline at 48 and 72 weeks in total body fat mass (kg 
and % body fat) by dual-energy x-ray absorptiometry (DXA) 
b.  Change from baseline at 48 weeks in VAT, SAT, and trunk fat mass 
(kg) by DXA 
c.  Proportion of participants who achieve a reduction from baseline at 
48 weeks in the following measures of obesity: 
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i. 
WC ≥ 5 cm 
ii. 
Body weight ≥ 5%, ≥ 10%, and ≥ 15% 
iii. 
Fat mass ≥ 5%, ≥ 10%, and ≥ 15% by DXA 
iv. 
Fat mass ≥ 10% with <5% decrease (or an increase) in lean 
mass by DXA 
d.  Percentage of weight loss due to fat mass or lean mass at 48 weeks by 
DXA 
e.  Change from baseline at 48 and 72 weeks in fat mass (kg and % body 
fat) by bioelectrical impedance analysis (BIA) 
f.  Change from baseline at 48 and 72 weeks in total body lean mass (kg 
and % body lean) by DXA and BIA and appendicular lean mass by 
DXA 
3. Safety and tolerability measurements throughout 48 weeks: 
a. Incidence and severity of treatment emergent adverse events 
(TEAEs), treatment-related AEs, serious adverse events (SAEs) 
and evaluation of TEAEs of special interest (including significant 
muscle, skin, and gastrointestinal TEAEs, malignancy, and 
pancreatitis) 
b. Clinical safety laboratory evaluation, including anti-drug 
antibodies (ADA) 
c. Vital signs (temperature, blood pressure, pulse rate) 
4. Proportion of patients with change from baseline in categorical 
classification of obesity at any time up to 48 weeks: 
a. BMI categories: 
i. Healthy weight: 18.5 kg/m2 to 24.9 kg/m2 
ii. Overweight: 25 kg/m2 to 29.9 kg/m2 
iii. Obesity class 1: 30 kg/m2 to 34.9 kg/m2 
iv. Obesity class II: 35 kg/m2 to 39.9 kg/m2 
v. Obesity class III: ≥ 40 kg/m2 
b. WHtR ratio categories: <0.5; 0.5-0.59; ≥0.6 [1] 
5. Change from baseline in HbA1c at 48 weeks  
6. Change from baseline at 24, 48, and 72 weeks in: 
 
Quality of Life Short Form 36 survey (SF-36) total score and 
physical functioning score 
 
Impact of Weight on Quality of Life-Lite for Clinical Trials 
survey (IWQoL-Lite for CT) total score and physical function 
score 
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Study Design 
This is a multicenter, randomized, double-blind, placebo-controlled (for 
bimagrumab) study of i.v. bimagrumab, alone or in addition to open label s.c. 
semaglutide to investigate efficacy and safety in overweight or obese men 
and women. 
Participants will be randomized to one of the following nine treatment arms 
(bimagrumab or placebo by i.v. infusion, semaglutide by s.c. injection; exact 
doses of semaglutide, by subcutaneous injection, to be determined, not to 
exceed 2.5 mg) for the 48-week core treatment period: 
1. Placebo + no semaglutide 
2. Placebo + semaglutide 1.0 mg 
3. Placebo + semaglutide 2.4 mg 
4. Bimagrumab 10 mg/kg + no semaglutide 
5. Bimagrumab 10 mg/kg + semaglutide 1.0 mg 
6. Bimagrumab 10 mg/kg + semaglutide 2.4 mg 
7. Bimagrumab 30 mg/kg + no semaglutide 
8. Bimagrumab 30 mg/kg + semaglutide 1.0 mg 
9. Bimagrumab 30 mg/kg + semaglutide 2.4 mg 
The core treatment period is followed by a 24-week open-label treatment 
extension period (which will remain blinded until after the 48-week database 
lock and study unblinding), during which 2 of the treatment arms will follow 
a modified treatment assignment: 
1. Switch from placebo to bimagrumab 30 mg/kg + no semaglutide 
2. No change; Placebo + semaglutide 1.0 mg; placebo replaced by no 
treatment after study unblinding 
3. No change; Placebo + semaglutide 2.4 mg; placebo replaced by no 
treatment after study unblinding 
4. Switch from bimagrumab 10 mg/kg to 30 mg/kg + no semaglutide 
5. No change; bimagrumab 10 mg/kg + semaglutide 1.0 mg 
6. No change; bimagrumab 10 mg/kg + semaglutide 2.4 mg 
7. No change; bimagrumab 30 mg/kg + no semaglutide 
8. No change; bimagrumab 30 mg/kg + semaglutide 1.0 mg 
9. No change; bimagrumab 30 mg/kg + semaglutide 2.4 mg 
The extension period is then followed by a 32-week post-treatment follow-up 
period, during which all study treatments will be withdrawn for all arms. 
The study will consist of a screening visit to assess eligibility, a baseline visit, 
followed by clinic visits/phone contacts every 4 weeks during the treatment 
and follow-up periods. 
Number of 
participants (planned) 
; 
 participants per treatment group 
Investigational 
product, dosage and 
mode of 
administration 
1. Low dose bimagrumab F 10 mg/kg by i.v. infusion 
2. High dose bimagrumab F 30 mg/kg by i.v. infusion 
For both dose levels, loading doses at Weeks 1 (Day 1) and 4, followed by 
q12 week dosing (Weeks 16, 28, 40, 52, and 64); there will be no loading 
dose for Arm 1 during switch from placebo to bimagrumab. 
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Reference therapy, 
dosage and mode of 
administration: 
Bimagrumab placebo: Formulation buffer composed of histidine, trehalose 
and polysorbate by i.v. infusion. 
Doses at Weeks 1 (Day 1), 4, 16, 28, and 40; at Weeks 52 and 64, placebo 
infusion will be replaced by no treatment after the 48-week database lock and 
study unblinding. 
Comparator therapy, 
dosage and mode of 
administration 
1. Low dose semaglutide – 1.0 mg s.c. weekly 
Dose escalation schedule listed below 
 
Weeks 1 (Day 1) to 4: 0.25 mg s.c. weekly 
 
Weeks 5 to 8: 0.5 mg s.c. weekly 
 
Weeks 9 to 71: 1.0 mg s.c. weekly  
2. High dose semaglutide – 2.4 mg s.c. weekly 
Dose escalation schedule listed below (exact doses to be determined, 
not to exceed 2.5 mg) 
 
Weeks 1 (Day 1) to 4: 0.25 mg s.c. weekly 
 
Weeks 5 to 8: 0.5 mg s.c. weekly 
 
Weeks 9 to 12: 1.0 mg s.c. weekly 
 
Weeks 13 to 16: 1.7 mg s.c. weekly* 
 
Weeks 17 to 71: 2.4 mg s.c. weekly* 
*Semaglutide doses of 1.7 mg and 2.4 mg may be substituted with 1.5 mg 
and 2.5 mg, respectively, based on availability of semaglutide pens. 
Duration of Study 
Up to 110  weeks, which includes an up to 6-week screening period, a 
baseline visit, a 72-week treatment period (48 weeks core plus 24 weeks 
extension), and a 32-week post-treatment follow-up period. 
Key Inclusion 
Criteria 
 
A written informed consent must be obtained before any study-related 
assessments are performed. 
 
Men and women between 18 and 80 years, inclusive; women of child-
bearing potential (defined as those who are not post-menopausal or post-
surgical sterilization) must meet both of the following criteria: 
 
Two negative pregnancy tests (at screening and at randomization, 
prior to dosing) 
 
Use of intrauterine device, from at least 3 months before the baseline 
visit through at least 4 months after the last dose of 
bimagrumab/placebo i.v., and an additional contraceptive (barrier) 
method from screening through at least 4 months after the last dose 
of bimagrumab/placebo i.v. 
 
Body mass index (BMI) ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 with one or more 
obesity-associated comorbidities (e.g., hypertension, insulin resistance, 
sleep apnea, or dyslipidemia) 
 
Stable body weight (± 5 kg) within 90 days of screening, and body weight 
<150 kg 
 
Have a history of at least one self-reported unsuccessful behavioral effort 
to lose body weight 
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 
Able to communicate well with the Investigator, comply with the study 
requirements and adhere to the diet and activity programs for the study 
duration 
Key Exclusion 
Criteria 
 History of, or known hypersensitivity to, monoclonal antibody drugs or a 
contraindication to semaglutide (Ozempic® or Wegovy®) 
 Use of other investigational drugs at the time of enrollment or within 30 
days or 5 half-lives of enrollment, whichever is longer, or longer if 
required by local regulations 
 Treatment with any medication for the indication of obesity within the 
past 30 days before screening 
 Diagnosis of diabetes, requiring current use of any antidiabetic drug or  
*	+D 
 Note: Metabolic syndrome is not an exclusion, even if managed with an 
anti-diabetic drug such as metformin or an SGLT2 inhibitor.  A diagnosis 
of prediabetes or impaired glucose tolerance managed exclusively with 
non-pharmacologic approaches (e.g., diet and exercise) is not an 
exclusion. 
 Any chronic infections likely to interfere with study conduct or 
interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human 
immunodeficiency virus (HIV). History of hepatitis A or hepatitis C 
successfully treated is not exclusionary. Active COVID-19 infection. 
 Donation or loss of 400 mL or more of blood within 8 weeks prior to 
initial dosing, or longer if required by local regulation, or plasma 
donation (> 250 mL) within 14 days prior to the first dose 
 
Any disorder, unwillingness, or inability not covered by any of the other 
-@+4=;176+:1<-:1)?01+016<0-6>-;<1/)<7:J;781617651/0<2-78):,1B-
the participantJ;;).-<A7:+75841)6+-?1<0<0-8:7<7+74 
Sample Size 
Justification: 
 participants will be randomized to 1 of 9 treatment 
groups. The sample size calculation is based on the primary efficacy estimand 
for weight.  Based on the FDA guidance on treatment for weight 
management, the minimum meaningful treatment effect for weight loss is 5% 
of baseline body weight over 1 year of treatment.  Assuming the minimum 
treatment effect of % weight loss with a standard deviation (SD) of , for a 
minimum effect size of 
[2, 3], a sample size of 
 participants per 
treatment arm will have approximately 
% statistical power to detect a 
treatment difference between any active group and placebo/no treatment 
using a 2-sided t-test at alpha=
.  Assuming a 
% dropout rate, 
enrollment will target 55 participants per treatment arm.  
Sample size was estimated using a t-test for 2 means in NQuery Advisor V9.1 
(www.statsols.com). [4, 5] 
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Statistical Methods 
All randomized participants who received at least one dose of study 
medication will be included in an Gintention-to-treatH population (treatment 
policy strategy). Baseline and efficacy results will be summarized by 
randomized treatment arm with active treatment arms compared to 
placebo/no treatment, and combination treatment arms to each monotherapy 
of the same dose. 
Safety and tolerability results will be summarized by actual treatment 
received. 
A detailed statistical analysis plan (SAP) will be finalized prior to database 
lock and will describe all planned analyses. 
Data 
Monitoring/Other 
Committee 
A data monitoring committee (DMC) will be convened to review the 
available safety data after 
% of participants have been treated for at least 
days, and periodically thereafter, with ad hoc meetings as necessary. The 
committee will consist of at least 2 independent clinicians, knowledgeable in 
obesity treatment, and 1 independent biostatistician. Up to 2 additional non-
voting members from the Sponsor with relevant safety and statistical 
expertise may also be included. Prior to convening the first DMC data review 
meeting, a DMC charter will be drafted and approved by the committee 
members. The primary role of the DMC is to advise on study conduct to 
ensure participant safety. This may include recommendations to discontinue a 
treatment arm or the study as a whole. 
 
 
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1.2. 
Study Schema  
 
 
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1.3. Schedule of Activities (SoA)  
Core Treatment Period (Screening through Week 48) 
Study Phase 
SCR 
B/L 
Core Treatment 
Visit (V), Phone (P) 
 
 
 
 
 
 
 
 
 
 
Week b 
-
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 PARTICIPANT RELATED INFORMATION AND ASSESSMENTS  
Clinic Visit 
X 
X 
  
X 
  
X 
X 
  
X 
X 
  
  
X 
  
X 
Phone Call 
  
  
X 
  
X 
  
  
X 
  
  
X 
X 
  
X 
  
Informed consent 
X 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Optional genetic and future use of 
samples informed consent c 
X 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Demography 
X 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Inclusion/Exclusion criteria 
S  
 Sd 
  
  
  
  
  
  
  
  
  
  
  
  
  
Medical History 
X 
X 
  
  
  
  
  
  
  
  
  
  
  
  
  
Con Meds/Therapies 
X 
X 
Drug screen 
S 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Body height 
X 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Hep B and C/HIV 
X 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Lipid Panel 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FSH e, HbA1c, TSH e 
S 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
RANDOMIZATION & DRUG ADMINISTRATION 
Randomization 
  
X 
  
  
  
  
  
  
  
  
  
  
  
  
  
Drug administration: 
bimagrumab/placebo IV 
  
X 
  
Xf 
  
  
X 
  
  
X 
  
  
X 
  
  
Drug administration: semaglutide SC 
(self-administered) g 
  
Weekly to week 71 
EFFICACY 
Body weight, including BIA h 
X 
X 
  
X 
  
X 
X 
  
X 
X 
  
  
X 
  
X 
Waist circumference 
X 
X 
  
X 
  
X 
X 
  
X 
X 
  
  
X 
  
X 
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Study Phase 
SCR 
B/L 
Core Treatment 
Visit (V), Phone (P) 
 
 
 
 
 
 
 
 
 
 
Week b 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DXA Scan 
  
Xb 
  
  
  
X 
  
  
X 
  
  
  
  
  
X 
 
  
X 
  
  
  
X 
  
  
X 
  
  
  
  
  
X 
QoL Questionnaires i 
  
X 
  
  
  
X 
  
  
X 
  
  
  
  
  
X 
 
 
X 
SAFETY 
Adverse Events 
  
X 
Physical Examination j 
X 
X 
  
X 
  
X 
  
  
X 
  
  
  
X 
  
X 
Vital signs k 
X 
X 
  
X 
  
X 
X 
  
X 
X 
  
  
X 
  
X 
ECG 
X 
  
  
  
  
X 
  
  
  
  
  
  
  
  
X 
Hematology l (CBC) 
X 
X 
  
X 
  
X 
  
  
X 
  
  
  
X 
  
X 
Clinical chemistry l 
X 
X 
  
X 
  
X 
  
  
X 
  
  
  
X 
  
X 
Coagulation l 
X 
X 
  
X 
  
X 
  
  
X 
  
  
  
X 
  
X 
Urine chemistry l 
  
X 
  
  
  
X 
  
  
X 
  
  
  
X 
  
X 
Urinalysis 
X 
X 
  
  
  
X 
  
  
X 
  
  
  
X 
  
X 
Pregnancy test n 
X 
X 
  
X 
  
X 
X 
  
X 
X 
  
  
X 
  
X 
Blood draw: Safety Biomarkers l, o 
  
X o 
  
X o 
  
X o 
  
  
X o 
  
  
  
X o 
  
X o 
Blood draw: 
 
  
X 
  
  
  
X 
  
  
X 
  
  
  
  
  
X 
Blood draw: Anti-drug antibodies 
  
X 
  
X 
  
X 
  
  
X 
  
  
  
  
  
X 
Blood draw: 
 
 
X 
  
X 
  
X 
X 
  
X 
X 
  
  
  
  
X 
Training: eDiary, exercise program, 
semaglutide self-administration 
  
X 
  
  
  
  
  
  
  
  
  
  
  
  
  
Dietary/physical activity counselling 
  
X 
  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Exercise program r 
  
X 
eDiary completion s 
  
X 
 
 
 
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Extension and Post-Treatment Follow-Up Periods (Week 52 through End of Study) 
Study Phase 
Extension Treatment 
EOTa 
Post-Treatment Follow-Up 
EOSa 
Visit (V), Phone (P) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Week b 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 PARTICIPANTS RELATED INFORMATION AND ASSESSMENTS 
Clinic Visit 
X 
  
  
X 
  
X 
  
  
X 
  
  
X 
  
X 
Phone Call 
  
X 
X 
  
X 
  
X 
X 
  
X 
X 
  
X 
  
Con Meds/Therapies 
X 
RANDOMIZATION & DRUG ADMINISTRATION 
Drug administration: 
bimagrumab/placebo IV 
X 
  
  
Xf 
  
  
  
  
  
  
  
  
  
  
Drug administration: semaglutide SC 
(self-administered) g 
Weekly to Week 71 
 
 
 
 
 
 
 
 
EFFICACY 
Body weight, including BIA h 
X 
  
  
X 
  
X 
  
  
X 
  
  
X 
  
X 
Waist circumference 
X 
  
  
X 
  
X 
  
  
X 
  
  
X 
  
X 
DXA Scan 
  
  
  
  
  
X 
  
  
  
  
  
X 
  
  
 
  
  
  
  
  
X 
  
  
  
  
  
X 
  
  
QoL Questionnaires i 
  
  
  
  
  
X 
  
  
  
  
  
X 
  
  
 
X 
SAFETY 
Adverse Events 
X 
Physical Examination j 
  
  
  
X 
  
X 
  
  
X 
  
  
X 
  
  
Vital signs k 
X 
  
  
X 
  
X 
  
  
X 
  
  
X 
  
X 
ECG 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Hematology l (CBC) 
  
  
  
X 
  
X 
  
  
X 
  
  
X 
  
  
Clinical chemistry l 
  
  
  
X 
  
X 
  
  
X 
  
  
X 
  
  
Coagulation l 
  
  
  
X 
  
X 
  
  
X 
  
  
X 
  
  
Urine chemistry l 
  
  
  
X 
  
X 
  
  
X 
  
  
X 
  
  
Urinalysis 
  
  
  
X 
  
X 
  
  
X 
  
  
X 
  
  
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Study Phase 
Extension Treatment 
EOTa 
Post-Treatment Follow-Up 
EOSa 
Visit (V), Phone (P) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Week b 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy test n 
X 
  
  
X 
  
X 
  
  
  
  
  
  
  
  
Blood draw: Safety Biomarkers l, o 
  
  
  
  
  
X o 
  
  
  
  
  
X o 
  
  
SAFETY 
Blood draw: 
 
 
  
  
  
  
  
X 
  
  
  
  
  
X 
  
 
Blood draw: Anti-drug antibodies 
  
  
  
  
  
X 
  
  
  
  
  
  
  
  
Blood draw: 
 
 
  
  
  
  
  
X 
  
  
  
  
  
  
  
  
OTHER ASSESSMENTS 
Dietary/physical activity counselling 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
  
Exercise program r 
X 
eDiary completion s 
X 
Abbreviations: SCR, screening; B/L=baseline; D=day; EOS=end of study; V=visit; P=phone; BIA=bioimpedance analysis; DXA= dual-energy X-ray absorptiometry; 
HbA1C=hemoglobin A1C; PD=pharmacodynamic; ECG= electrocardiogram; Hep=hepatitis; HIV=human immunodeficiency virus; CBC=complete blood count ; aPTT=activated 
partial thromboplastin time; PT/INR=prothrombin time/international normalized ratio; IUD=intrauterine device; DNA=deoxyribonucleic acid; eDiary=electronic diary; S=remains 
as source data at site and is not collected in the eCRF. 
a. 
EARLY TREATMENT DISCONTINUATION: At the time of discontinuing treatment early, the End of Treatment (EOT) visit should be conducted as 
b/placebo. 
 
OPTIONAL GENETIC INFORMED CONSENT:
d. INCLUSION/EXCLUSION: Eligibility to be confirmed prior to dosing. 
e. 
SCREENING FSH, HbA1c and TSH: Follicle-stimulating hormone testing to be conducted for post-menopausal women at screening (see footnote o for 
other timepoints). HbA1c required for all participants at screening. Thyroid-stimulating hormone testing to be conducted at screening unless a normal value 
is documented within 6 months prior to screening. 
f. 
WEEKS 4 AND 64 PRE-DOSE SAFETY LABS: Prior to administering the Week 4 and Week 64 doses of bimagrumab/placebo, Investigators must obtain 
and review results of safety labs against the safety guidance presented in Sections 10.6, 10.7, and 10.8, Appendices 6, 7, and 8. 
g. SEMAGLUTIDE ADMINISTRATION: Semaglutide is to be administered s.c. weekly by the participant at home. On study visit days, participants will 
take their dose on site, in the presence of study personnel, after study assessments. The last dose of semaglutide is taken at the beginning of week of 71, on 
Day 498. 
h. BODY WEIGHT, INCLUDING BIA: Bioelectrical impedance scale to be used to measure weight, body fat, and lean (muscle) mass. 
i. 
QOL QUESTIONNAIRES: Questionnaires include IWQoL-Lite for CT and SF-36. 
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j. 
PHYSICAL EXAMINATION: A complete physical examination is required, including skin assessment for acne or lesions and, for males, assessment of 
gynecomastia. 
k. VITAL SIGNS: Includes body temperature, blood pressure, pulse rate. 
l. 
CLINICAL LABORATORY TESTS: Refer to Appendix 2 for a complete list of all analytes included in each panel. 
m. BLOOD DRAWS: Blood draws should be collected in the fasted state (approximately 8 hours), except for the screening visit, where fasting is not required. 
Time of last meal should be noted. 
n. PREGNANCY TEST: Serum pregnancy test is required for all female participants at screening. Urine pregnancy test can be used at all other visits for pre-
menopausal female participants, unless serum is required based on local requirements. 
o. SAFETY BIOMARKERS: A sample for safety biomarkers will be collected for all participants but will only be analyzed for participants with abnormal 
liver or pancreatic test results per safety labs. 
r. 
EXERCISE PROGRAM: Participants will be encouraged to exercise for at least 150 minutes per week. 
s. 
eDIARY: Exercise and dosing information collected.   
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2. 
INTRODUCTION  
2.1. 
Study Rationale  
Obesity is one of the greatest public health challenges of the 21st century. Its prevalence has 
tripled in many countries since the 1980s, and the numbers of those affected continue to rise at 
an alarming rate. In 2016, globally more than 1.9 billion adults (39%) were overweight; of these, 
650 million (13%) were obese. In addition to causing various physical disabilities and 
psychological problems, excess weight drastically increases a person’s risk of developing a 
number of comorbidities, including cardiovascular disease, cancer, insulin resistance and type 2 
diabetes mellitus (T2DM) [6]. The Global Burden of Disease study reported that 4.7 million 
people died prematurely in 2017 as a result of obesity [7]. 
A body weight reduction of 5-10% has been associated with significant and clinically 
meaningful improvements in insulin sensitivity, glycemic control, hypertension, and 
dyslipidemia. Combining lifestyle management with pharmacotherapy is increasingly recognized 
as an effective and safe treatment option for many patients with obesity [8]. Currently, 5 
medications are on the market for long term use in the US, the latest is once weekly s.c. 
semaglutide (a GLP1-receptor agonist), approved in 2021 for chronic weight management in 
adults with obesity (BMI >30 kg/m2) or overweight with at least one weight-related condition 
(BMI >27 kg/m2). 
Adipose tissue, in particular, visceral adipose tissue (VAT), is involved in energy storage and is 
considered an endocrine and paracrine organ that affects several metabolic processes, through 
the release of cytokines and bioactive mediators. Cytokines and mediators can influence body 
weight, as well as insulin resistance and pathogenesis of diabetes mellitus, lipid metabolism and 
inflammation, thus explaining premature atherosclerosis in people with obesity [9-11]. VAT 
rather than body mass index (BMI) determines metabolic risk and is associated with metabolic 
syndrome even in participants with normal BMI, defined as normal weight obese [12-14]. 
Therefore, loss of VAT might be of great importance to prevent cardiovascular disease. 
Most weight loss programs are able to reduce body weight within the first few weeks; however, a 
significant amount of the weight loss includes loss of LBM. Also, obesity pharmacotherapy 
results in loss of LBM in connection with loss of FM [15], so it is important to focus on body 
composition in an effort to maintain LBM. The loss of LBM is problematic for several reasons, 
including impacts on health, ability to conduct activities of daily living and potential effects on 
emotion and psychological states. The loss of LBM impedes sustainability of successful obesity 
therapy by causing lowered resting energy expenditure/metabolism, fatigue, decline in 
neuromuscular function, and increased risk for injury [16-18]. In an effort to offset LBM loss, 
studies have incorporated exercise in conjunction with a weight loss program; however, this has 
only provided modest benefit, most likely due to the modest caloric expenditure experienced 
with moderate exercise [19, 20]. In general, it is recognized that for every 1 kg of FM lost, 
approximately 0.26 kg of lean tissue is lost in post-menopausal women [21]. Importantly, the 
lean mass lost is only partially regained with weight gain. There are no approved obesity 
interventions that preserve or build lean mass while promoting fat mass loss. 
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Bimagrumab is a recombinant human monoclonal antibody binding to the activin receptor type II 
(ActRII). Bimagrumab previously has been studied in muscle wasting indications and has been 
shown to increase skeletal muscle mass in healthy volunteers, in patients with sporadic inclusion 
body myositis (sIBM), and in patients with sarcopenia. 
In a recent randomized double-blind, placebo-controlled study including 75 overweight or obese 
patients with type 2 diabetes mellitus (T2DM), bimagrumab 10 mg/kg i.v. every 4 weeks for 48 
weeks in addition to lifestyle intervention, resulted in a marked loss in FM, an increase in LBM, 
and improvement in a range of metabolic biomarkers [5]. Participants lost 5.1 kg (p<0.001) body 
weight in the bimagrumab group vs. the placebo group with a decrease in placebo-adjusted WC 
of 9.5 cm (p<0.001). Patients lost 20.5% of FM, had a 3.6% increase in LBM, and had a decrease 
of 0.76 percentage points in their HbA1c levels, whereas placebo patients only had a decrease in 
total body FM of 0.5%, LBM reduction of 0.8%, and an increase of 0.04 percentage points in 
HbA1c levels. The loss in total body FM and gain in LBM led to net weight losses of 6.5% and 
0.8% in patients receiving bimagrumab or placebo, respectively. Additionally, greater reductions 
in VAT and hepatic fat fraction were observed in the bimagrumab group versus placebo group. 
The expansion of the lean mass (i.e., skeletal muscle) compartment in the presence of negative 
energy balance and weight loss is a novel feature in weight loss pharmacotherapy. Overall, 
adverse effects (AEs) were balanced between the bimagrumab and placebo groups. Participants 
on bimagrumab vs. placebo reported more muscle symptoms, diarrhea and nausea. The 
frequency of gastrointestinal AEs was highest during the first dosing period with bimagrumab 
and diminished with repeat dosing. More patients in the bimagrumab group experienced transient 
elevations of pancreatic and liver enzymes, which tended to subside after the first dose of 
bimagrumab. The etiology of these elevations is unclear but could be related to mobilization of 
adipocyte triglycerides and amino acids as a new metabolic equilibrium is reached during early 
bimagrumab dosing. 
The planned study is designed to evaluate the effect of bimagrumab alone or in addition to the 
approved obesity therapeutic semaglutide in obese or overweight participants with at least one 
obesity related co-morbidity, without T2DM. The main endpoint in the study is body weight. 
Other endpoints include waist circumference, body composition, and evaluation of the impact of 
treatment on metabolic parameters and safety. 
2.2. 
Background  
The activin type 2 receptors ActRIIA and ActRIIB, abbreviated as ActRII, modulate signals for 
ligands belonging to the transforming growth factor beta (TGF-β) superfamily. These included 
growth differentiation factor 8 (GDF8, myostatin), GDF11, and activins, which are all negative 
regulators of skeletal muscle growth, acting via the ActRII receptor signaling pathway to inhibit 
muscle protein synthesis and myocyte differentiation and proliferation. A pharmacological way 
to block these ligands’ action to increase muscle mass and hence exercise capacity is through 
inhibition of ActRII [22]. Blockade of ActRII results in hypertrophy of skeletal muscle through 
an increase in size of existing myofibers [23-25], which in turn is hypothesized to improve 
peripheral insulin sensitivity, since skeletal muscle is one of the major glucose-utilizing tissues in 
the body [22]. 
Activin receptor signaling is also active in adipose tissue and contributes to the regulation of 
adipose tissue mass.  Adipocytes express the highest levels of the type 1 receptor ALK7 and are 
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the major tissue source of activin B. In rodents, knockout of the ALK7 receptor decreases total 
fat mass and confers resistance to diet-induced obesity. In humans, single nucleotide 
polymorphisms in the ALK7 gene are associated with lower BMI and resistance to obesity [26, 
27]. 
Bimagrumab, a recombinant human, monoclonal antibody (modified IgG, λ2) binds 
competitively to the ActRII with a greater affinity than its natural ligands. 
Information currently available on pharmacology, toxicology, pharmacokinetics, and 
pharmacodynamics are reported in the Investigator Brochure (please refer to most recent edition) 
and has been obtained from in vitro experiments, animal studies, toxicology studies, and human 
trials. 
2.2.1. 
Preclinical Pharmacology  
The co-administration of CDD866, a murinized version of bimagrumab, with semaglutide was 
studied in obese C57Bl/6J mice. Animals were fed a high fat diet (60% of total caloric input as 
fat) for 20 weeks and reached body weights of approximately 50 grams (twice normal) at the 
time the therapeutic interventions were initiated. The high fat diet was continued throughout the 
experimental period and the two drugs were evaluated individually and when co-administered, 
along with vehicle-alone groups. The primary efficacy assessment was total body fat mass 
determined weekly by magnetic resonance spectroscopy. Each drug alone exhibited the expected 
effect on body fat mass and lean mass and when administered together, the decrease in body fat 
mass was at least additive. Greater than 30% body fat mass loss was observed over 3 weeks with 
the co-administration of the two highest dose levels of bimagrumab and semaglutide. Other than 
the expected decrease in food intake in the semaglutide arms of the study, there were no safety or 
tolerability issues observed. Specifically, a quantitative open field test of behavior showed no 
significant differences between the drug-treated groups and vehicle-treated groups. 
Teratogenicity and Reproductive Toxicity Data 
In embryo-fetal development studies, bimagrumab was seen to be developmentally toxic in the 
rat and rabbit and teratogenic in the rat (NOAEL of 1 mg/kg). The exact mechanism, direct or 
indirect, underlying the reproductive organ changes observed with bimagrumab is unclear. A 
pre- and postnatal development (dose range-finding) study in the rat was terminated at the end of 
the weaning phase of pup development because of a high incidence of litter death in the control 
animals (reason unknown). In rats dosed at 1 or 10 mg/kg there was an increase in the number of 
females unable to complete the process of parturition and an increase in the number of stillborn 
pups. This observation was not seen in the control animals. 
Women of child-bearing potential, who are not post-menopausal or post-surgical sterilization, 
must use highly effective contraception during treatment and for 4 months after their last dose of 
bimagrumab due to the risk of teratogenicity and embryo-fetal death observed with bimagrumab 
in animals. 
Clinical studies evaluating single and multiple doses of bimagrumab showed no difference in 
changes in testicular volume or sperm count or quality between male participants receiving 
bimagrumab and those receiving placebo. Furthermore, monoclonal antibodies are large 
molecules that do not readily (< 1%) pass the blood-testis barrier and are not readily excreted in 
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seminal fluid. As a result of this data, no contraception is required for male participants 
participating in bimagrumab trials. 
2.2.2. 
Clinical Data  
Human safety and tolerability 
Bimagrumab has been studied in Phase 2/3 clinical studies that have evaluated the safety, 
tolerability, PK and efficacy of bimagrumab in different populations, including 5 phase 2a/proof 
of concept studies (recovery from disuse, sporadic inclusion body myositis (sIBM), sarcopenia 
with mobility limitations, and cancer cachexia and chronic obstructive pulmonary disease 
cachexia), two phase 2b studies (sarcopenia and hip fracture recovery) and one phase 2b/3 study 
in sIBM patients. Study results to date indicate bimagrumab has a good safety profile; is 
generally well tolerated; has predictable nonlinear kinetics caused by target-mediated drug 
disposition; and reliably increases muscle volume and decreases adipose tissue levels. Body 
composition changes begin within 2 weeks of administration and continue throughout exposure 
in both healthy volunteers and patients regardless of age. 
Transient cases of episodic, involuntary muscle contractions (referred to as “cramps or spasms”), 
acne and diarrhea of mostly mild intensity have been observed in study participants with 
symptoms occurring more frequently in participants receiving the highest doses of drug 
(30 mg/kg). Several participants have discontinued treatment in earlier studies because of an AE 
(exacerbation of acne, muscle cramps or diarrhea). Data from a dedicated hormonal study 
showed no effect on the hormonal axis except for a decrease in FSH levels in postmenopausal 
women with complete resolution after bimagrumab clearance. Data from a dedicated 24-week 
cardiac safety study indicated no effect of bimagrumab on multiple cardiac parameters in the 
context of the expected skeletal muscle hypertrophy. 
Human pharmacokinetic data 
Bimagrumab exhibits a non-linear kinetic profile following single and repeat i.v. administrations, 
very likely caused by target-mediated drug disposition. The total clearance (CL) of bimagrumab 
is concentration-dependent and is the sum of linear CL and non-linear CL. The half-life is also 
concentration dependent. The half-life ranges from 19 days in the linear portion of the profile 
(high bimagrumab concentrations) to 5 days when the maximum CL is achieved. Based on 
graphical exploration, the nonlinear CL saturation seems to occur below a threshold serum 
concentration of approximately 10 μg/mL. 
Bimagrumab, like any human IgG antibody, is expected to be eliminated via intracellular 
catabolism, following fluid-phase or receptor mediated endocytosis. Since the majority of 
immunoglobulins undergo proteolytic degradation, bimagrumab is not expected to yield active 
metabolites. Since bimagrumab is a human IgG with large molecular size (~150 kDa), little 
intact immunoglobulin can be filtered by the kidney, hence little/no antibody is expected to be 
excreted in the urine. 
There was only limited evidence of an effect of the dietary protein intake on the PK of 
bimagrumab. PK profiles of bimagrumab in healthy volunteers of Japanese descent, older adults 
up to 83 years of age, obese adults, and patients with sIBM were similar to those of healthy 
younger adults. 
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Human pharmacodynamic data 
Consistent, measurable increases in muscle size have been observed in clinical studies. In 
healthy volunteers, single doses of 3, 10 and 30 mg/kg i.v. and repeat doses of 3 and 10 mg/kg 
resulted in gains in thigh muscle volume of +2.7-.:75*);-416-7>-:84)+-*7)<L	
?--3;
post dose. The increase in muscle volume was associated with improvements in physical 
function in patients with sIBM (+6.0%) in an early PoC study. The muscle increase was also 
seen in a recent Phase 3 study, but the improved function was not repeated. Patients with 
sarcopenia saw 8% increases in muscle volume 8 weeks after a single dose of 30 mg/kg, which 
resulted in clinically relevant improvements in muscle strength and mobility performance.  
Consistent, dose-dependent, linear decreases in total body fat measured by DXA have also been 
observed in clinical studies with bimagrumab. Reductions in fat mass of between 2.5 and 3.5 kg 
over 6 months occurred in participants with sarcopenia, hip fracture, sporadic inclusion body 
myositis and in healthy volunteers participating in a cardiac safety study and in elderly healthy 
participants.  Efficacy results in obese and overweight patients with T2DM are reported in 
Section 2.1. 
For more information on bimagrumab, please refer to the most recent version of the Investigators 
Brochure.  For information on semaglutide, refer to the current Wegovy® or Ozempic® package 
insert. 
2.3. 
Benefit/Risk Assessment  
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events (AEs) of bimagrumab can be found in the Investigators Brochure and in 
the Package Insert for semaglutide. 
2.3.1. 
Risk Assessment  
2.3.1.1. 
Investigational Intervention Bimagrumab  
A total of 21 clinical studies including 3 extension studies have been conducted with 
bimagrumab, including 
 adults, with 
 receiving the bimagrumab. Dose levels ranged 
from 0.01 mg/kg to 30 mg/kg, with larger studies using 1 mg, 3 mg, and 10 mg/kg as i.v. 
infusion, s.c. injections of 2 mg/kg and fixed doses of 
 mg, 
 mg, 
 mg, 
 mg, and 
 mg; the majority of most studies assessed i.v. infusions of 10 mg/kg and 30 mg/kg. 
Treatment durations ranged from single to multiple doses over 6 to 12 months. The longest 
continuous exposure in obese adults with T2DM was 12 months with doses of 10 mg/kg body 
weight (
 mg maximum) and 12-26 months in patients with sIBM. 
Muscle symptoms 
In a recent bimagrumab study in obese or overweight patients with T2DM, an increased AE 
incidence of muscle spasms (usually described as muscle cramps) of 
 (
%), all mild 
(
%) or moderate (
%) in intensity was observed in the bimagrumab group. 
 (
%) 
participant reported muscle fatigue and 
 (
%) reported muscle stiffness; both were mild. 
The majority of the AEs were judged to be related to study drug by the Investigator. In the 
placebo group there were 2 muscle events, 
 (
%) of muscle spasms and 
 (
%) of 
muscle twitching. In previous studies, in different indications, muscle symptoms were also seen 
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in the form of muscle spasms, tightness and twitching. In general, muscle symptoms are mostly 
mild or moderate, transient, painless, and of short duration. For the details of previous individual 
studies please refer to the Investigators Brochure. 
The etiology and clinical meaning of these observations are not known. Similar symptoms have 
been reported with at least one other anabolic molecule, a beta-2 adrenergic agonist [28] and are 
commonly reported by adults performing muscle building exercise. 
Skin symptoms 
In the obesity study, in the bimagrumab group there were  (
%) participants with at least one 
AE of skin symptoms, while there were  (
% in the placebo group). All skin symptoms were 
mild. There were  participants in the bimagrumab group who reported AEs of acne (1), blister 
(1), and rash (2). 
In previous studies, in different indications, skin symptoms were seen mostly in the form of acne 
and rash. In general, skin symptoms are mostly mild or moderate, transient, painless, and of short 
duration. For the details of previous individual studies please refer to the current edition of the 
Investigators Brochure. 
Acne has been confirmed in these studies by dermatology consult and biopsy. Treatment has 
been successful with good skin hygiene using a 4-10% benzoyl peroxide wash and over the 
counter topical treatments. On occasion, a prescription, topical or oral antibiotic (i.e., 
minocycline 100 mg bid), was recommended. However, early standard of care intervention is 
recommended in participants when acne presents. A possible mechanistic link between 
bimagrumab and skin reactions remains unclear. 
Diarrhea 
In the obesity study, diarrhea was reported in 
 participants (
%, 
% mild, 
% 
moderate) in the bimagrumab group versus  (
%, 
% mild, 
% moderate) participants in 
the placebo group. Diarrhea has also been observed more frequently in other studies in different 
indications. 
Reproductive organs 
Data from a dedicated hormonal study demonstrated no clinically or statistically significant 
effect of bimagrumab on circulating testosterone levels and no effect on pituitary-adrenal axes in 
either gender and minimal effect on the pituitary-gonadal axes in men. Suppression of FSH 
levels in postmenopausal women and premenopausal women of non-childbearing potential has 
been observed with no associated safety risk identified. However, in premenopausal women 
with an IUD there is an associated risk of disruption of menstrual cycles. All effects were 
transient and resolved after bimagrumab exposure ended. Semen analysis data from the multiple 
dose study suggest that three doses of 10 mg/kg have no effect on sperm count or quality in 
males. 
Women of childbearing potential must use highly efficacious contraception (see study eligibility 
criteria, Section 5). 
 
 
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Immunogenicity 
A treatment related anti-drug antibody (ADA) response has been observed infrequently in 
participants treated with bimagrumab. Nevertheless, there was no evidence of an infusion or 
hypersensitivity reaction that could be related to immunogenicity or any sign of immune 
complex formation in the clinical trials performed so far. No positive signal in the 
immunogenicity assay was accompanied by a change in the bimagrumab PK profile. 
Lipase and amylase elevations, and pancreatitis 
Observations of dose-dependent, transient, elevations of lipase and/or amylase have been 
identified in several studies in the bimagrumab clinical program. The biological explanation for 
this temporal rise in pancreatic enzymes seen in some individuals is not yet fully understood. 
As of 1 March 2022, 4 participants in 3 studies have experienced acute pancreatitis among 
 
participants administered bimagrumab. All 4 participants recovered from the acute pancreatitis, 2 
discontinued study drug and 2 were considered to be related to study treatment. One participant 
on placebo experienced pancreatitis. To reduce the potential risk of elevated pancreatic 
enzymes and pancreatitis, study participants with acute or chronic pancreatitis or with elevated 
amylase and/or lipase will be excluded as per Section 5.2. 
2.3.1.2. 
Semaglutide (Wegovy®, Ozempic®)  
Risk of Thyroid C-Cell Tumors 
In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent 
increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime 
exposure at clinically relevant plasma exposures. It is unknown whether semaglutide causes 
thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human 
relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined. Cases 
of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported 
in the post marketing period; the data in these reports are insufficient to establish or exclude a 
causal relationship between MTC and GLP-1 receptor agonist use in humans. 
Acute pancreatitis 
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has 
been observed in patients treated with GLP-1 receptor agonists, including semaglutide. Acute 
pancreatitis was observed in patients treated with semaglutide in clinical trials. After initiation of 
semaglutide, observe patients carefully for signs and symptoms of acute pancreatitis (including 
persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be 
accompanied by vomiting). If acute pancreatitis is suspected, semaglutide should promptly be 
discontinued, and appropriate management should be initiated. If acute pancreatitis is confirmed, 
semaglutide should not be restarted. 
Acute Gallbladder Disease 
In Wegovy® randomized clinical trials, cholelithiasis was reported by 
% of semaglutide -
treated patients and 
% of placebo-treated patients. Cholecystitis was reported by 
% of 
semaglutide -treated patients and 
% of placebo-treated patients. Substantial or rapid weight 
loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease 
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was greater in semaglutide -treated patients than in placebo-treated patients, even after 
accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder investigations 
and appropriate clinical follow-up are indicated. 
Hypoglycemia 
Semaglutide lowers blood glucose and can cause hypoglycemia. In a trial of patients with type 2 
diabetes and BMI greater than or equal to 27 kg/m2, hypoglycemia (defined as a plasma glucose 
less than 54 mg/dL) was reported in 
% of semaglutide-treated patients versus 
% of 
placebo-treated patients. One episode of severe hypoglycemia (requiring the assistance of 
another person) was reported in one semaglutide-treated patient versus no placebo-treated 
patients. 
Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of 
hypoglycemia. 
Acute Kidney Injury 
There have been post marketing reports of acute kidney injury and worsening of chronic renal 
failure, which have in some cases required hemodialysis, in patients treated with semaglutide. 
Patients with renal impairment may be at greater risk of acute kidney injury, but some of these 
events have been reported in patients without known underlying renal disease. Most of the 
reported events occurred in patients who had experienced nausea, vomiting, or diarrhea, leading 
to volume depletion. 
Monitor renal function when initiating or escalating doses of semaglutide in patients reporting 
severe adverse gastrointestinal reactions. Monitor renal function in patients with renal 
impairment reporting any adverse reactions that could lead to volume depletion. 
Hypersensitivity 
Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with 
semaglutide. If hypersensitivity reactions occur, discontinue use of semaglutide, treat promptly 
per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a 
previous hypersensitivity to semaglutide or any of the excipients in semaglutide. Anaphylaxis 
and angioedema have been reported with other GLP-1 receptor agonists. 
Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 
receptor agonist because it is unknown whether such patients will be predisposed to these 
reactions with semaglutide. 
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes 
In a trial of patients with T2DM and BMI greater than or equal to 27 kg/m2, diabetic retinopathy 
was reported by 
% of semaglutide-treated patients and 
% placebo-treated patients. 
In a 2-year trial with semaglutide 0.5 mg and 1 mg once-weekly injection in patients with type 2 
diabetes and high cardiovascular risk, diabetic retinopathy complications occurred in patients 
treated with semaglutide injection (
%) compared to placebo (
%). The absolute risk 
increase for diabetic retinopathy complications was larger among patients with a history of 
diabetic retinopathy at baseline (semaglutide injection 
%, placebo 
%) than among patients 
without a known history of diabetic retinopathy (semaglutide injection 
%, placebo 
%). 
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Rapid improvement in glucose control has been associated with a temporary worsening of 
diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic 
retinopathy complications has not been studied. Patients with a history of diabetic retinopathy 
should be monitored for progression of diabetic retinopathy. 
Heart Rate Increase 
Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed in 
semaglutide-treated patients compared to placebo in clinical trials. More patients treated with 
semaglutide compared with placebo had maximum changes from baseline at any visit of 10 to 19 
bpm (
% versus 
%, respectively) and 20 bpm or more (
% versus 
%, respectively).  
Instruct patients to inform their healthcare providers of palpitations or feelings of a racing 
heartbeat while at rest during semaglutide treatment. If patients experience a sustained increase 
in resting heart rate, discontinue semaglutide. 
Suicidal Behavior and Ideation 
Suicidal behavior and ideation have been reported in clinical trials with other weight 
management products. Monitor patients treated with semaglutide for the emergence or worsening 
of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. 
Discontinue semaglutide in patients who experience suicidal thoughts or behaviors. Avoid 
semaglutide in patients with a history of suicidal attempts or active suicidal ideation. 
Adverse reactions 
Semaglutide was evaluated for safety in 3 randomized, double-blind, placebo-controlled trials 
that included 
 patients with overweight or obesity treated with semaglutide for up to 68 
weeks and a 7 week off drug follow-up period. In clinical trials, 
% of patients treated with 
semaglutide and 
% of patients treated with placebo permanently discontinued treatment as a 
result of adverse reactions. The most common adverse reactions leading to discontinuation were 
nausea (
% versus 
%), vomiting (
% versus %), and diarrhea (
% versus 
%) for 
semaglutide and placebo, respectively. The most frequent adverse events reported as AEs were 
nausea/vomiting reported in 
% / 
% respectively of patients on semaglutide versus 
 % / 
% of patients on patients treated with placebo. Diarrhea/constipation was reported in 
% /
% 
respectively of patients on semaglutide and 
% / 
% of patients on placebo. Abdominal pain 
was reported in 
% of patients on semaglutide and 
% on placebo. 
2.3.1.3. 
Study Procedures  
Infusion risks 
Infusion-related reactions can occur with monoclonal antibodies. Hypersensitivity reactions can 
manifest as fever, chills, urticaria, dyspnea, headaches, myalgia and/or hypotension. No serious 
infusion reaction (anaphylaxis) has been seen in patients treated with bimagrumab. If a severe 
hypersensitivity reaction occurs, administration of bimagrumab should be discontinued and 
appropriate therapy initiated. 
Dual-Energy X-ray Absorptiometry (DXA) 
DXA scans in this study will be used to assess bone mineral density and body composition (i.e., 
fat and lean mass). The effective radiation dose of a DXA whole body scan on an adult is 2.1 
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µSv. Therefore, the total amount of radiation exposure per participant from 6 DXA scans will be 
about 12.6 µSv over a period of 96 weeks. This amount of radiation is less than 14 days of 
background exposure (approximately 0.03 µSv per hour at sea level). For effective radiation 
doses under 3 µSv (300 mrem), the risk is considered to be minimal [29]. Therefore, the  
radiation exposure in this study involves minimal risk. 
2.3.2. 
Benefit Assessment  
All participants enrolled in the study may benefit from lifestyle interventions including diet and 
physical activity, and regular monthly contact with the site staff. Potential benefits associated 
with bimagrumab and semaglutide are described below. 
2.3.2.1. 
Bimagrumab  
Based on recent clinical data in overweight and obese diabetic participants, treatment with 
bimagrumab in non-diabetic obesity is expected to result in decreased body weight and waist 
circumference, with improved body composition resulting from loss of fat mass and increase of 
lean mass. In the diabetic participant study, bimagrumab also resulted in reduction in visceral fat 
mass, reduction in hepatic fat fraction, and improved insulin sensitivity and glucose control.  
Bimagrumab in combination with semaglutide may mitigate the loss of lean mass. 
2.3.2.2. 
Semaglutide  
Semaglutide is approved in the USA and the EU as a chronic weight management treatment in 
obese or overweight adults. Once weekly s.c. semaglutide results in substantial percentage 
change and absolute change in body weight as reported in a recent meta-analysis [4]. Compared 
with placebo, once weekly semaglutide also led to superior reductions in body weight, waist 
circumference and BMI compared with placebo; however, losses in lean mass (approximately 
10%) were also observed [30]. Furthermore, the effect on improving other cardiometabolic risk 
factors and health-related quality of life was more pronounced for once-weekly semaglutide 
relative to placebo. 
2.3.3. 
Overall Benefit Risk Conclusion  
Considering the measures taken to minimize risk to participants participating in this study, the 
potential risks identified in association with bimagrumab are justified by the anticipated benefits 
that may be afforded to participants who are obese or overweight. 
 
 
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3. 
OBJECTIVES, ENDPOINTS, AND ESTIMANDS  
Table 1: 
Table of Objectives and Endpoints 
OBJECTIVES 
ENDPOINTS 
Primary Objective 
1. To assess the treatment effect of 
bimagrumab, semaglutide, and 
bimagrumab in addition to 
semaglutide vs placebo on body 
weight 
1. Change from baseline in total body weight at 48 weeks 
 
OBJECTIVES 
ENDPOINTS 
Secondary Objectives 
1. To assess the treatment effect of 
bimagrumab, semaglutide, and 
bimagrumab in addition to 
semaglutide vs placebo on waist 
circumference (WC) 
1. Change from baseline in WC (cm) at 48 and 72 weeks 
2. To assess treatment effects on fat 
mass, visceral adipose tissue (VAT), 
trunk fat mass, subcutaneous 
adipose tissue (SAT), and lean mass 
(body composition) 
2.    a. Change from baseline at 48 and 72 weeks in total 
body fat mass (kg and % body fat) by DXA 
b.  Change from baseline at 48 and 72 weeks in VAT, 
SAT, and trunk fat mass (kg) by DXA 
c.  Proportion of participants who achieve a reduction 
from baseline at 48 weeks in the following measures of 
obesity: 
i. 
WC ≥ 5 cm 
ii. 
Body weight ≥ 5%, ≥ 10%, and ≥15% 
iii. 
Fat mass ≥ 5%, ≥ 10%, and 15% by DXA 
iv. 
Fat mass ≥ 10% with <5% decrease (or 
an increase) in lean mass by DXA 
d.  Percentage of weight loss due to fat mass or lean 
mass at 48 weeks by DXA 
e.  Change from baseline at 48 and 72 weeks in fat 
mass (kg and % body fat) by bioelectrical impedance 
analysis (BIA) 
f.  Change from baseline at 48 and 72 weeks in total 
body lean mass (kg and % body lean) by DXA and 
BIA and appendicular lean mass by DXA 
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3. To assess the safety and tolerability 
of bimagrumab, semaglutide and 
bimagrumab in addition to 
semaglutide 
3. Safety and tolerability measurements throughout 48 
weeks: 
a. Incidence and severity of treatment emergent 
adverse events (TEAEs), treatment-related AEs, 
serious adverse events (SAEs) and evaluation of 
TEAEs of special interest (including significant 
muscle, skin, and gastrointestinal TEAEs, 
malignancy, and pancreatitis) 
b. Clinical safety laboratory evaluation, including 
anti-drug antibodies (ADA) 
c. Vital signs (temperature, blood pressure, pulse rate) 
4. To assess the proportion of patients in 
each treatment group experiencing a 
change in the categorical 
classification of obesity based on 
BMI and waist-to-height ratio 
(WHtR) group 
4. Proportion of patients with change from baseline in 
categorical classification of obesity at any time up to 
48 weeks: 
a. BMI categories: 
i. 
Healthy weight:   18.5 kg/m2 to 24.9 kg/m2 
ii. 
Overweight:         25 kg/m2 to 29.9 kg/m2 
iii. 
Obesity class 1:    30 kg/m2 to 34.9 kg/m2 
iv. 
Obesity class II:   35 kg/m2 to 39.9 kg/m2 
v. 
!*-;1<A+4);;Dkg/m2 
b.    WHtR ratio categories: <0.5; 0.5-D[1] 
5. To assess treatment effects on 
glucose metabolism 
5. Change from baseline in HbA1c at 48 weeks 
6. To assess treatment effects on self-
reported health status and weight-
related quality of life 
6. Change from baseline at 24,48, and 72 weeks in: 
a. Quality of Life Short Form 36 survey (SF-36) total 
score and physical functioning score 
b. Impact of Weight on Quality of Life-Lite for 
Clinical Trials survey (IWQoL-Lite for CT) total 
score and physical function score 
 
 
 
 
 

 
 
 
 
 
 
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3.1. 
Estimands  
The primary estimand will quantify the average treatment effect of bimagrumab, semaglutide or 
a combination of bimagrumab with semaglutide relative to placebo after 48 weeks, in all 
randomized participants who received at least one dose of study treatment, regardless of 
adherence to treatment and regardless of intercurrent events%01;.7447?;<0-G<:-)<5-6<8741+AH
strategy which closely adheres to full analysis set (FAS) with an intention-to-treat (ITT) 
population. 
The following expansion of the primary estimand will quantify the average treatment effect of 
combination treatment of semaglutide with bimagrumab relative to each monotherapy of the 
same dosage strength after 48 weeks, in all randomized participants regardless of adherence to 
treatment and regardless of intercurrent events (ICE). 
As a sensitivity analysis, the primary estimand will also be assessed using the Gtrial product or 
hypothetical -;<15)6,H to quantify the average treatment effect in all participants who adhered to 
treatment and did not experience any ICEs. Intercurrent events will be detailed in the SAP. 
3.1.1. 
Estimands of Secondary Objectives  
The estimands of the secondary objectives will follow the treatment policy strategies outlined for 
the primary estimand.  Details of the secondary estimands and the ICEs that are relevant will be 
provided in the SAP. 
Statistical analyses for the treatment extension and post-treatment follow-up periods will be 
detailed in the SAP. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
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4. 
STUDY DESIGN  
4.1. 
Overall Design  
This is a non-confirmatory, randomized, double-blind, placebo-controlled (for bimagrumab) 
multi-center study of i.v. bimagrumab, alone or in addition to open label s.c. semaglutide, to 
investigate the efficacy and safety in adult men and women between the ages of 18 and 80, 
inclusive, who are obese or who are overweight with at least one obesity related co-morbidity. 
Women must be post-menopausal, post-surgically sterilized or using an intrauterine device. 
 participants are planned to be enrolled and randomized to 1 of 9 treatment 
arms (see Section 6.1). 
The total study duration will be approximately 104 weeks and will consist of an up to 6-week 
screening period, a 72-week treatment period (48 weeks core followed by 24 weeks of 
extension), and a 32-week post-treatment follow-up period. Overview of the study design can be 
found in the study schema in Section 1.2. 
Screening (Week -6 to day -1) 
Potential participants will undergo the screening activities listed in the Schedule of Activities 
(SoA) Section 1.3 to determine their eligibility for the study (see enrollment criteria Section 5).  
Screening assessments that are outside of the Week -6 to Day -1 window may be repeated once. 
The Investigator must recommend a lifestyle intervention [31] that includes dietary counseling 
for weight loss with a daily caloric deficit of approximately 500 kcal and with protein intake of 
at least 1.2 g/kg/day to support muscle anabolism. Participants will also be encouraged to 
exercise for at least 150 minutes per week. 
These lifestyle interventions will be explained during the screening visit and initiated at the 
baseline visit. 
Baseline (Day 1, up to 15 minutes prior to dosing) 
Eligible participants will return to clinic to undergo baseline assessments as defined in the SoA 
Section 1.3. Baseline assessments must be completed  prior to dosing. DXA scans may be 
performed up to 14 calendar days prior to dosing. 
During this visit, participants will be provided with an 
 device in the form of a wrist 
band. Participants will be advised to wear the band at all times for the entire course of the study. 
The band should be removed during showering and may be removed during sleep if desired. 
Site staff will assist participants with downloading study applications on their mobile phone that 
will send visit reminders, collect patient reported outcomes and provide general study 
information to the participant. 
Randomization and Dosing (Day 1) 
Upon completion of all baseline activities, eligible participants will be randomized to one of the 
9 treatment arms listed in Section 6.1. 
Bimagrumab or placebo will be administered i.v. over a period of ~30 minutes, followed by 
flushing for ~15 minutes and a 15-minute post-flush observation period that will include safety 
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and tolerability observations and PK sampling. Bimagrumab will be dosed based on the previous 
visit body weight at 10 mg/kg or 30 mg/kg depending on the assigned treatment arm. 
Participants assigned to semaglutide treatment arms will receive their first dose of semaglutide in 
clinic, along with training on how to store semaglutide pens and self-administer injections at 
home. 
Following all assessments, participants may be discharged from the Investigator site when the 
Investigator judges them to be medically stable, in good general health, and not needing further 
observation. 
Participants assigned to semaglutide treatment arms will be sent home with a semaglutide pen (to 
be self-administered, once weekly), disposal containers and instructions to return any unused 
pens to clinic at their next scheduled visit. 
Core Treatment Period (Weeks 1 to 48) 
For the duration of the core treatment period, participants should: 
 Follow the dietary and exercise recommendations prescribed by the Investigator. 
 Wear the 
band. 
 Complete weekly eDiaries. Occasional missed diaries are permissible in the absence 
of persistent non-compliance. 
For participants assigned to semaglutide arms, self-administer weekly semaglutide injections and 
return all used and unused pens at their next clinic visit. 
Participants will return to clinic: 
 at Weeks 4, 16, 28 and 40 for i.v. bimagrumab or placebo dosing. Additional 
assessments will be performed as detailed in the SoA Section 1.3. 
 at Weeks 12, 24, and 48 for DXA scanning and other assessments detailed in the SoA 
Section 1.3. 
Site staff will call participants at Weeks 2, 8, 20, 32, 36, and 44 to ensure there are no safety 
issues and to address any questions the participant may have. 
Qualified dieticians will reach out to participants on a monthly basis to provide dietary and 
exercise counseling, and to calculate participantJ; dietary intake via 24-hour recall assessment 
(see study operations manual for detailed description). If desired, these touchpoints may be 
combined with the in-clinic visits or safety calls. 
Should participants report any adverse events over the phone, these will be recorded in the 
eCRF. 
Open Label Extension Treatment Period (Weeks 49 to 72) 
The open label extension treatment period will be conducted similarly to the core treatment 
period described above, however, participants randomized to study treatment arms 1 
(bimagrumab placebo) and 4 (bimagrumab 10 mg/kg) will switch treatment to bimagrumab 30 
mg/kg at Week 52.  Dispensing of drug product in a manner that maintains the blind is described 
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in Section 6.4.4. Note, the extension treatment period will be made open label after the 48-week 
database lock and study unblinding. 
For the duration of the extension treatment period, participants should continue to follow dietary 
and exercise recommendations, wear the 
 band, complete the weekly eDiaries, and 
must self-administer weekly semaglutide (for participants assigned to semaglutide arms) as in the 
core treatment period. 
Participants will return to clinic at Weeks 52 and 64 for i.v. bimagrumab or placebo dosing. 
Additional assessments will be performed as detailed in the SoA Section 1.3. Note: no placebo 
infusions will be administered to treatment arms 2 and 3 after the study is made open label, e.g., 
after the Week 48 database lock and study unblinding. 
Site staff will call participants at Weeks 56, 60, and 68 as described above.  Should participants 
report any adverse events over the phone, these will continue to be recorded in the eCRF. 
Qualified dieticians will continue to counsel participants on a monthly basis as described above. 
End of Treatment Visit (End of Week 72) 
Participants will return for the End of Treatment (EOT) Visit at the end of Week 72 or at the 
time of early termination to perform DXA scan and other assessments as detailed in the SoA 
Section 1.3.  If study intervention is permanently discontinued early, the EOT visit should be 
conducted as soon as possible, per Section 7.1. 
Post-Treatment Follow-Up Period (Weeks 73 to 104) 
Upon completion of the EOT visit, all study treatment will be withdrawn (bimagrumab/placebo 
and semaglutide) and participants will be followed for an additional 32 weeks. 
For the duration of the post-treatment follow-up period, participants should follow dietary and 
exercise recommendations, wear the 
 band, and complete the weekly eDiaries.  
Participants will return to clinic at Weeks 84 and 96 for efficacy and safety assessments to be 
performed as detailed in the SoA Section 1.3. 
Site staff will call participants at Weeks 76, 80, 88, 92, and 100, as described above.  Should 
participants report any adverse events over the phone, these will continue to be recorded in the 
eCRF. 
Qualified dieticians will continue to counsel participants on a monthly basis as described above. 
Participants will return for their end of treatment follow up visit at the end of Week 96 for DXA 
scan and other assessments detailed in the SoA Section 1.3. 
End of Study Visit (End of Week 104) 
Participants will return for their final end of study (EOS) visit at the end of Week 104 for vital 
sign and BIA measurements.  During this visit, site staff should assist participants in removing 
study-specific applications from their personal devices. 
If study intervention is permanently discontinued early during one of the treatment periods, the 
EOT visit should be conducted at that time, followed by an EOS visit at least 12 weeks after the 
last dose of bimagrumab or placebo. 
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If study participation is permanently discontinued early during the post-treatment follow-up 
period, the EOS visit should be conducted at least 12 weeks after the last dose or bimagrumab or 
placebo. 
4.2. 
Scientific Rationale for Study Design  
The design of this Phase 2 study addresses the primary and the key secondary objectives of 
assessing if the efficacy of bimagrumab i.v. administered in addition to semaglutide s.c. is 
superior to either drug administered alone or to placebo and if the efficacy of bimagrumab i.v. is 
superior to s.c. semaglutide. 
The rationale for key elements of the study design include: 
 Randomization: To provide equal access to any of the treatment arms regardless of 
gender, age, or baseline characteristics. 
 Stratification: To decrease the chance of an imbalance in gender across treatment 
arms 
 Triple-blind with regards to bimagrumab: The participant, Investigator and 
Sponsor will be blinded to bimagrumab dose and placebo-bimagrumab to avoid bias 
in adverse event and efficacy reporting, and to avoid any potential confounding effect 
of intentional and unintentional behavioral changes by participants. 
 Open label with regards to semaglutide: Commercially available semaglutide will 
be used in the study.  Because it is delivered in a pre-filled syringe, packaged and 
labeled by the manufacturer, it is not possible to blind semaglutide. The inclusion of 
two doses: a very low dose 1.0 mg and the registered dose of 2.4 mg, as well as the 
addition of the double-blinded bimagrumab treatment to all semaglutide doses, should 
mitigate the risk of bias. 
 Placebo arm: Inclusion of a placebo group will allow the analysis of whether or not 
bimagrumab treatment is more effective than a standard treatment approach based on 
lifestyle intervention. 
 Primary endpoint: The FDA guidance for phase 3 clinical trials in weight 
management recommends that in general, a product can be considered effective for 
weight management if after 1 year of treatment either of the following occurs: 
 The difference in mean weight loss between the active-product and placebo-
treated groups is at least  percent and the difference is statistically significant 
or 
 The proportion of participants who lose greater than or equal to  percent of 
baseline body weight in the active-product group is at least 
 percent, is 
approximately 
the proportion in the placebo-treated group, and the 
difference between groups is statistically significant. 
For phase 2 clinical trials, the FDA guidance states that primary efficacy endpoints 
should include a comparison of the mean absolute or percent change in body weight 
between the active-product and placebo-treated groups. 
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 Population: Men and women, fulfilling the criteria with regards to overweight and 
obesity from the FDA Draft Guidance [32] of being at significant risk for weight-
related morbidity and mortality, and who have already tried and failed lifestyle 
modifications. Bimagrumab is teratogenic in animal studies, therefore women who 
are not post-menopausal or post-surgically sterilized must meet the relevant eligibility 
criteria to minimize the risk that women of child-bearing potential experience a 
contraceptive failure or should wish to become pregnant. 
 Treatment extension: Continued weight loss may not be observed during the 2nd 
year of weight loss treatment, as demonstrated in the STEP 5 study [33].  The 
extension treatment period in the current study will compare the results of 
bimagrumab and/or semaglutide treatment for continued weight loss and fat mass 
reduction in the 2nd year of treatment. 
 Post-treatment follow-up:  Prevention of weight regain following successful weight 
loss is a key challenge for obesity management.  After withdrawal of treatment, 
weight regain is common for methods of weight loss dependent on reduced caloric 
intake. One year after withdrawal of semaglutide, for example, participants in the 
STEP 1 trial regained two-thirds of their prior weight loss (Wilding 2022).  The post-
treatment follow-up period in the current study will compare the results of 
bimagrumab and/or semaglutide in maintenance of weight loss and composition of 
weight regain. 
4.3. 
Justification for Dose  
4.3.1. 
Bimagrumab Doses  
This study will evaluate two doses of bimagrumab 10 mg/kg and 30 mg/kg i.v., administered at 
baseline, Weeks 4, 16, 28, 40, 52, and 64. 
The dose of bimagrumab, 10 mg/kg i.v., administered to healthy volunteers and to obese/ 
overweight participants provided exposure levels above 10 μg/mL, at which the anabolic effect is 
observed, with levels maintained over the dosing interval of 4 weeks. PK/PD modelling has 
predicted that with dosing of 10 mg/kg at baseline, 4 weeks and 16 weeks, exposures will drop 
below 10 ug/mL for approximately half the time through 24 weeks and result in fat mass losses 
intermediate between those expected in the placebo group and the 30 mg/kg group. The 
10 mg/kg dose group has been included to help determine whether a lower dose of bimagrumab, 
when added to semaglutide, might result in near-maximal efficacy, superior tolerability, or both. 
The 30 mg/kg i.v. dose was administered as 2 doses 8 weeks apart in healthy volunteers and in 
patients with chronic obstructive lung disease with cachexia. A 30 mg/kg dose of bimagrumab is 
expected to achieve circulating levels sufficient to block the ActRIIB receptor (greater than 
~10 μg/ml) over nearly all dosing intervals. A serum level of bimagrumab above this threshold 
resulted in an increase in thigh muscle volume in healthy volunteers. 
The loading doses of bimagrumab 4 weeks apart is supported from a safety perspective by the 
findings from both the 13-week and 26-week toxicity studies with maximum exposure of 14 
weekly doses of 100 mg/kg. AUC and Cmax values of the 100 mg/kg i.v. dose level in the 
cynomolgus monkey toxicity studies are approximately 3 and 6 times greater than that expected 
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in humans from a second i.v. dose of 30 mg/kg of bimagrumab 8 weeks apart (14,710 Pg/day/mL 
vs. 5340 Pg/day/mL and 4480 Pg/mL vs. 726 Pg/mL). While this is the first time bimagrumab 
will be administered as seven 30 mg/kg doses, it is considered safe based on the 13- and 26-week 
toxicity study results and the clinical data noted previously.  The PK/PD modeling predicts the 
30 mg/kg doses at baseline, and Weeks 4, 16, 28, 40, 52, and 64 will maintain exposures above 
10 Pg/mL over nearly the entire 12-week interval between doses and yield a near-maximal 
treatment effect on fat mass loss. 
Participants in core treatment arms 1 (placebo; no semaglutide) and 4 (bimagrumab 10 mg/kg; no 
semaglutide) will be switched to the higher dose of bimagrumab (30 mg/kg) during the 24-week 
extension period in order to allow these participants to receive a dose of bimagrumab predicted 
to achieve maximal treatment effect during the 2nd year. 
4.3.2. 
Semaglutide Doses  
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a 
reduced calorie diet and increased physical activity for chronic weight management in adult 
patients with an initial BMI of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) 
in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 
diabetes mellitus, or dyslipidemia). 
Semaglutide is administered s.c. once weekly, on the same day each week, at any time of day, 
with or without meals. Treatment is initiated at 0.25 mg once weekly for 4 weeks. In 4-week 
intervals, the dose unit is increased until a dose of 2.4 mg is reached. The maintenance dose of 
Wegovy® is 2.4 mg once weekly. In this study the higher dose of semaglutide is the approved 
dose for obesity, while the lower dose of 1.0 mg s.c. per week is an approved dose for diabetes, 
and is predicted to yield body weight loss intermediate between no semaglutide and the 2.4 mg 
dose. The 1.0 mg dose group has been included to help determine whether a lower dose of 
semaglutide, when added to bimagrumab, might result in near-maximal efficacy, superior 
tolerability, or both. 
4.4. 
End-of-Study Definition  
The end of the study is defined as the date of the last scheduled procedure shown in the schedule 
of activities for the last participant in the study, globally. 
A participant is considered to have completed the study if the participant has completed all 
periods of the study including the last scheduled procedure shown in the SoA Section 1.3. 
5. 
STUDY POPULATION  
 overweight/obese men and women aged 18 F 80 years (inclusive) will be 
enrolled in the study. 
The Investigator must ensure that all participants being considered for the study satisfy the 
inclusion/exclusion criteria. No additional criteria should be applied by the Investigator, in order 
that the study population will be representative of all eligible participants. 
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Participant selection is to be established by checking through all eligibility criteria at screening 
and baseline. A relevant record (e.g., checklist) of the eligibility criteria must be stored with the 
source documentation at the study site. 
Deviation from any entry criterion (inclusion and exclusion) excludes a participant from 
enrollment into the study. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1. 
Inclusion Criteria  
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. A written informed consent must be obtained before any study-related assessments are 
performed. 
2. Men and women between 18 and 80 years, inclusive; women of child-bearing potential 
(defined as those who are not post-menopausal or post-surgical sterilization; see 
Section 10.4 Appendix 4) must meet both of the following criteria: 
 Two negative pregnancy tests (at screening and at randomization, prior to dosing) 
 Use of intrauterine device, from at least 3 months before the baseline visit through at 
least 4 months after the last dose of bimagrumab/placebo i.v., and an additional 
contraceptive (barrier) method from screening through at least 4 months after the last 
dose of bimagrumab/placebo i.v. 
3. Body mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 with one or more obesity-associated 
comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia). 
4. Stable body weight (±5 kg) within 90 days of screening, and body weight <150 kg. 
5. Have a history of at least one self-reported unsuccessful behavioral effort to lose body 
weight. 
6. Capable of using common software applications on a mobile device (smartphone). 
7. Access to an internet-enabled smartphone, tablet, or computer for the duration of the 
study, meeting minimal operations systems (OS) requirements. 
8. Able to communicate well with the Investigator, comply with the study requirements and 
adhere to the diet and activity programs for the study duration. 
 
5.2. 
Exclusion Criteria  
Participants are excluded from the study if any of the following criteria apply: 
1. History of, or known hypersensitivity to, monoclonal antibody drugs or a 
contraindication to semaglutide (Ozempic® or Wegovy®). 
2. Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-
lives of enrollment, whichever is longer, or longer if required by local regulations. 
3. Lack of peripheral venous access. 
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4. Are not able or willing to comply with protocol requirements including lifestyle 
interventions, for example: 
a. History of clinically significant condition that precludes regular walking for exercise 
e.g., cardiovascular or pulmonary disease or osteoarthritis. 
b. Contraindication to following a 500-calorie daily deficit, high protein diet. 
5. Women who are pregnant or intend to become pregnant or are nursing. 
6. Diseases known to cause cachexia or muscle atrophy, or diseases known to cause GI 
malabsorption (e.g., inflammatory bowel disease, celiac disease, short bowel syndrome, 
pancreatic insufficiency). 
7. Use of any prescription drugs known to adversely affect muscle mass or body weight, 
including anti-androgens (e.g., gonadotropin hormone releasing hormone agonists, 
androgen receptor antagonists, glucocorticoids administered systemically for >2 weeks if 
dose is ≥10 mg of prednisone or equivalent within 12 weeks prior to Day 1 to EoS). Low 
dose estrogen replacement therapy in post-menopausal women is acceptable and 5-alpha 
reductase inhibitors in men are acceptable. Spironolactone and related drugs are 
acceptable in men and women. 
8. Treatment with any medication for the indication of obesity within the past 30 days 
before screening. 
9. Previous or planned (during the trial period) obesity treatment with surgery or a weight-
loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, 
if performed >1 year before screening; (2) lap banding, if the band has been removed >1 
year before screening; (3) intragastric balloon, if the balloon has been removed >1 year 
before screening; (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed >1 
year before screening or Plenity®, if discontinued at least 1 week prior to screening. 
10. Uncontrolled thyroid disease, defined as thyroid stimulating hormone above or below the 
normal range, at screening or within 6 months prior to screening. Hypothyroid patients 
treated with thyroid hormone replacement therapy must be on a stable dose for at least 6 
weeks prior to screening. 
11. Diagnosis of diabetes, requiring current use of any antidiabetic drug or HbA1c ≥ 6.5%. 
Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic 
drug such as metformin or an SGLT2 inhibitor.  A diagnosis of prediabetes or impaired 
glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet 
and exercise) is not an exclusion. 
12. History of malignancy of any organ system, treated or untreated within the past five years, 
regardless of whether there was evidence of local recurrence or metastases, except non-
melanoma skin cancer treated only with local therapy. Specifically excluded are 
participants with multiple endocrine neoplasia type 2 (MEN2) or a personal or family 
history of medullary thyroid cancer (MTC) or known elevation of blood calcitonin >50 
ng/L. 
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13. Known heart failure classified as New York Heart Association Class III and IV or a 
history of chronic hypotension, defined as systolic blood pressure <100 mmHg or 
diastolic blood pressure <50 mmHg. Uncontrolled hypertension, defined as systolic blood 
pressure >180 or diastolic blood pressure >100 mmHg at screening/baseline. 
14. ECG showing clinically significant abnormalities including any current supra-ventricular 
arrhythmia with an uncontrolled ventricular response (mean heart rate >100 beats per 
minute [bpm]) at rest despite medical or device therapy, or any history of spontaneous or 
induced sustained ventricular tachycardia (heart rate >100 bpm for 30 sec) despite 
medical or device therapy, or any history of resuscitated cardiac arrest or presence of an 
automated internal cardioverter-defibrillator. Prolonged QT syndrome or QTcF > 
450 msec (Fridericia Correction) for males and >470 msec for females at screening. 
15. History of unstable angina, myocardial infarction, coronary artery bypass graft surgery, 
or percutaneous coronary intervention (such as angioplasty or stent placement) within 
180 days of screening. 
16. History or presence of significant coagulopathy e.g., PT/INR >1.5. 
17. History of familial hypertriglyceridemia or history of fasting triglyceride > 500 mg/dL 
(5.65 mmol/L). 
18. Known history or presence of severe acute or chronic liver disease (compensated or 
decompensated), known cholelithiasis or cholecystitis or bile duct disease, acute or 
chronic pancreatitis (or medication associated with severe pancreatitis, such as valproate), 
or severe GI dysmotility syndrome including functional disorders such as severe irritable 
bowel syndrome. Serum lipase >2x upper limit of normal (ULN) or serum amylase > 2x 
ULN at screening. 
19. Liver injury as indicated by abnormal liver function tests such as AST, ALT, GGT, 
alkaline phosphatase, or serum bilirubin; 
 Any single transaminase >3x ULN. 
 Total bilirubin concentration increased above 1.5x ULN (except for cases of known 
Gilbert syndrome). 
20. History or presence of substantially impaired renal function as indicated by eGFR < 
45 mL/min/1.73 m2 or serum creatinine > 1.5x ULN or proteinuria > 2+ by urine dipstick 
or equivalent. 
21. Total WBC <3000/μL, neutrophils <1500/μL, hemoglobin <8.5 g/dL, or platelet count 
<100,000/μL at screening. 
22. Any chronic infections likely to interfere with study conduct or interpretation such as 
hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History 
of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 
infection. 
23. Donation or loss of 400 mL or more of blood within eight weeks prior to initial dosing, or 
longer if required by local regulation, or plasma donation (> 250 mL) within 14 days 
prior to the first dose. 
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24. Acute illness within the 30 days prior to screening that, in the opinion of the Investigator, 
affects the patient’s ability to participate in the study. 
25. Known or suspected abuse of alcohol or other substances including, but not limited to: 
a. Smoking more than one pack of cigarettes daily. 
b. Drinking 5 or more alcoholic beverages on each of 5 or more days in the past 30 days. 
c. Using cannabis more than twice weekly. 
d. Any use of heroin, cocaine, etc. 
26. Any disorder, unwillingness, or inability not covered by any of the other exclusion 
criteria, which in the Investigator’s opinion, might jeopardize the participant’s safety or 
compliance with the protocol. 
5.3. 
Lifestyle Considerations  
5.3.1. 
Meals and Dietary Restrictions  
Study participants will be counseled to follow a modest calorie restricted diet with a daily deficit 
of approximately 500 kcal. The following is a recommended, but not required, breakdown of 
daily calories: approximately 45-50% from carbohydrate, 20-25% from protein and 30% from fat 
intake throughout the study. Participants will be advised to consume at least 1.2 g/kg/body 
weight of protein as per guidelines for daily recommended protein intake for anabolism (WHO 
guidelines 2015). 
Counselling will be conducted by a dietician or a similar qualified healthcare professional every 
4 weeks during the study via visits/phone contacts to encourage dietary intake that will promote 
weight loss and document any change in dietary habits. During these dietician contacts, 
participants will be asked to recall all food and drink they have consumed in the previous 24 
hours. 
If BMI ≤ 22 kg/m2 is reached during the study, the recommended daily energy intake may be 
recalculated to promote weight maintenance.  If further, potentially undesirable weight loss 
continues, or if BMI is ≤ 18.5 kg/m2, the investigator should contact the Sponsor to discuss 
whether it is medically appropriate for the participant to continue in the study. See SOM for 
more information related to assessing dietary intake and calculating nutrient needs. 
Participants must fast for at least 8 hours prior to all visits that include blood sampling i.e., 
without food or liquids, except for water. Study medication and any medication which should be 
taken with or after a meal should be withheld on the day of the visit until blood samples have 
been obtained. 
For visits where PD samples are collected for analysis by the central lab, if the participant is not 
fasting as required, the participant should be called in for a new visit as soon as possible to have 
the fasting procedures done. Procedures requiring participants to fast include blood sampling of 
fasting plasma glucose (FPG), fasting serum insulin and lipid assessments. 
Participants should restrict alcohol consumption for the 24 hours prior to study visits. 
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5.3.2. 
Activity  
Participants will be encouraged to engage in at least 150 minutes of physical activity per week 
e.g., walking or climbing stairs. The 
 device worn by participants will be used to 
collect activity data. 
Additional details of the physical activity program and the 
 device can be found in the 
SOM. 
5.3.3. 
Other Restrictions  
Participants should refrain from smoking for one hour prior to study visits and during the study 
visits. 
Women of childbearing potential must use an intrauterine device (IUD), from at least 3 months 
before the baseline visit through at least 4 months after the last dose of bimagrumab/placebo i.v., 
and use an additional contraceptive (barrier) method after the screening visit through at least 4 
months after the last dose of bimagrumab/placebo. Additional information on highly effective 
contraception methods is provided in Section 10.4 Appendix 4. 
5.3.4. 
Support During Treatment Withdrawal Period  
During the treatment withdrawal period, participants will continue to have access to personnel 
who have experience in providing diet and exercise counseling. Options for additional resources 
to help lifestyle management will also be available to participants during this time. 
5.4. 
Screen Failures  
A screen failure occurs when a participant who has consented to participate in the clinical study 
is not subsequently assigned to study intervention, either due to a failure to meet the eligibility 
criteria or by choosing not to proceed to enrollment. 
A minimal set of screen failure information is required to ensure transparent reporting of screen 
failure participants to meet the CONSORT publishing requirements and to respond to queries 
from regulatory authorities. Minimal information includes demography, screen failure details, 
eligibility criteria, and any SAE. 
Individuals who do not meet the criteria for participation in this study may be rescreened once at 
the discretion of the Investigator. Rescreened participants should be assigned a new screening 
number for every screening/rescreening event.  Individuals with laboratory assessments that are 
outside of the Week -6 to Day -1 window may be reassessed once within the same screening 
event (without requiring a new screening number). 
6. 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY  
Study interventions are all pre-specified, investigational, and non-investigational medicinal 
products, medical devices and other interventions (e.g., behavioral) intended to be administered 
to the study participants during the study conduct. 
A summary of study interventions administered in this study is found in Table 2. Treatment arms 
are listed in Table 3. 
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The semaglutide dosing regimen employed in this study follows the guidance provided in the 
package insert for Wegovy®. However, due to Wegovy® supply constraints, Ozempic® pens 
will be used in place of Wegovy® pens as needed. Ozempic® pens contain the same active 
ingredients as Wegovy® pens. 
Site staff will provide participants with self-administration training specific to the type of 
semaglutide pen dispensed. 
Refer to the Ozempic® and Wegovy® package inserts for additional information and 
instructions on administration. 
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6.1. 
Study Interventions Administered  
Table 2: 
Study Interventions Administered 
Intervention Label 
Low dose bimagrumab 
High dose 
bimagrumab 
Placebo (for 
bimagrumab) 
Low dose semaglutide a 
High dose semaglutide a,b 
Intervention Name 
Bimagrumab 
Placebo 
Semaglutide 
Intervention 
Description 
Human monoclonal antibody to the activin 
receptor type II 
Placebo 
Glucagon-like peptide-1 (GLP-1) receptor agonist 
Type 
Biologic 
n/a 
Biologic 
Dose Formulation 
Liquid in a vial 
Autoinjector Pen 
Unit Dose Strength(s) 
Vial: 
 concentrate for solution for 
infusion contains 
 of bimagrumab in 
 (excluding 10% overfill) 
n/a 
0.25 mg, 0.5 mg, 1.0 mg 
0.25 mg, 0.5 mg, 1.0 mg, 1.7 
mg, and 2.4 mg 
Core Treatment Dosage 
Level(s) 
10 mg/kg at Weeks 1, 4, 
16, 28, and 40 
30 mg/kg at Weeks 
1, 4, 16, 28 and 40 
1 infusion at Weeks 1, 4, 
16, 28 and 40 
Weeks 1 to 4:   0.25 mg 
Weeks 5 to 8:    0.5 mg 
Weeks 9 to 48:  1.0 mg 
Weeks 1 to 4:    0.25 mg 
Weeks 5 to 8:      0.5 mg 
Weeks 9 to 12:    1.0 mg 
Weeks 13 to 16:  1.7 mg 
Weeks 17 to 48:  2.4 mg 
Extension Treatment 
Dosage Level(s) 
10 mg//kg at Weeks 52 
and 64 
30 mg/kg at Weeks 
52 and 64 
c1 infusion at Weeks 52 
and 64 
Weeks 49 to 71:  1.0 mg 
Weeks 49 to 71:  2.4 mg 
Route of 
Administration 
i.v. 
s.c. 
Use 
Experimental 
Placebo 
Active comparator 
IMP and NIMP/AxMP 
IMP 
Sourcing 
Provided centrally by the Sponsor 
Packaging and 
Labeling 
Study intervention will be provided as 3 vials per box. Each box and vial 
will be labeled as required per country requirement. 
Comparator will be provided as either a single pen 
(Ozempic®) or 4 pens per box (Wegovy®), depending on the 
dose to be administered. Each box and pen will be labeled as 
required per country requirement. 
Current / Former 
Name(s) / Alias 
Bimagrumab 
Semaglutide (Ozempic®/Wegovy®) 
a Participants who are unable to tolerate a weekly dose of 0.5 mg or higher may decrease in dose to the preceding dose level. 
b Semaglutide doses of 1.7 mg and 2.4 mg may be substituted with 1.5 mg and 2.5 mg, respectively, based on availability of semaglutide pens. 
c Placebo infusions to be discontinued after the Week 48 database lock and study unblinding. 
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Table 3: 
Study Treatment Arms 
Arm Title 
Arm Type 
Arm Description 
Associated 
Intervention Labels 
Core: Bimagrumab 
placebo 
Extension: 30 mg/kg 
bimagrumab 
Core: Placebo 
Extension: 
Experimental 
Core Treatment Period: 
Participants will receive i.v. 
bimagrumab placebo at baseline, and 
at Weeks 4, 16, 28 and 40 
Extension Treatment Period: 
Participants will receive 30 mg/kg 
i.v. bimagrumab at Weeks 52 and 64 
Treatment Arm 1a 
Bimagrumab placebo 
+ 1.0 mg semaglutide 
Placebo + 
Comparator 
All Treatment Periods: Participants 
will receive i.v. bimagrumab placebo 
at baseline, and at Weeks 4, 16, 28, 
40, 52, and 64, and 1.0 mg s.c. 
semaglutide weekly per the dose 
escalation schedule 
Treatment Arm 2a 
Bimagrumab placebo 
+ 2.4 mg semaglutide 
Placebo + 
Comparator 
All Treatment Periods: Participants 
will receive i.v. bimagrumab placebo 
at baseline, and at Weeks 4, 16, 28, 
40, 52, and 64, and 2.4 mg s.c. 
semaglutide weekly per the dose 
escalation schedule 
Treatment Arm 3a 
Core: 10 mg/kg 
bimagrumab 
Extension: 30 mg/kg 
bimagrumab 
Experimental 
Core Treatment Period: 
Participants will receive 10 mg/kg 
i.v. bimagrumab at baseline, and at 
Weeks 4, 16, 28 and 40 
Extension Treatment Period: 
Participants will receive 30 mg/kg 
i.v. bimagrumab at Weeks 52 and 64 
Treatment Arm 4 
10 mg/kg 
bimagrumab + 1.0 
mg semaglutide 
Experimental + 
Comparator 
All Treatment Periods: Participants 
will receive 10 mg/kg i.v. 
bimagrumab at baseline, and at 
Weeks 4, 16, 28, 40, 52, and 64, and 
1.0 mg s.c. semaglutide weekly per 
the dose escalation schedule 
Treatment Arm 5 
10 mg/kg 
bimagrumab + 2.4 
mg semaglutide 
Experimental + 
Comparator 
All Treatment Periods: Participants 
will receive 10 mg/kg i.v. 
bimagrumab at baseline, and at 
Weeks 4, 16. 28, 40, 52, and 64, and 
2.4 mg s.c. semaglutide weekly per 
the dose escalation schedule 
Treatment Arm 6 
30 mg/kg 
bimagrumab 
Experimental 
All Treatment Periods: Participants 
will receive 30 mg/kg i.v. 
bimagrumab at baseline, and at 
Weeks 4, 16, 28, 40, 52, and 64 
Treatment Arm 7 
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Arm Title 
Arm Type 
Arm Description 
Associated 
Intervention Labels 
30 mg/kg 
bimagrumab + 1.0 
mg semaglutide 
Experimental + 
Comparator 
All Treatment Periods: Participants 
will receive 30 mg/kg i.v. 
bimagrumab at baseline, and at 
Weeks 4, 16. 28, 40, 52, and 64, and 
1.0 mg s.c. semaglutide weekly per 
the dose escalation schedule 
Treatment Arm 8 
30 mg/kg 
bimagrumab + 2.4 
mg semaglutide 
Experimental + 
Comparator 
All Treatment Periods: Participants 
will receive 30 mg/kg i.v. 
bimagrumab at baseline, and at 
Weeks 4, 16, 28, 40, 52, and 64, and 
2.4 mg s.c. semaglutide per the dose 
escalation schedule 
Treatment Arm 9 
aPlacebo infusions to be discontinued after the 48-week database lock and study unblinding.  
6.2. 
Preparation, Handling, Storage, and Accountability   
The Investigator or designee must confirm appropriate conditions (e.g., temperature) have been 
maintained during transit for all study intervention received, and any discrepancies reported and 
resolved before use of the study intervention. 
Only participants enrolled in the study may receive study intervention, and only authorized site 
staff may supply, prepare, or administer study intervention. 
All study intervention must be stored in a secure, environmentally controlled, and monitored 
(manual or automated) area in accordance with the labeled storage conditions with access limited 
to the Investigator and authorized site staff. 
The Investigator and study pharmacist are responsible for study intervention accountability, 
reconciliation, and record maintenance (i.e., receipt, reconciliation, and final disposition 
records). 
Further guidance and information for the final disposition of unused study interventions are 
provided in the pharmacy manual. 
6.3. 
Assignment to Study Intervention  
Eligible participants will be randomly assigned to one of nine treatment arms using a centralized 
interactive web randomization system (IWRS). Before the study is initiated, directions for the 
log-in information will be provided to each site. 
Randomization will be balanced in a 1:1:1:1:1:1:1:1:1 ratio with approximately 
 participants 
per treatment arm. Stratification across the treatment arms will be based on gender. 
The randomization schedule will be generated as a randomized block design using SAS version 
9.4 or higher. 
The randomization number becomes definitive once a participant has been dosed and it may not 
be reassigned. 
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6.4. 
Blinding  
The study is triple blinded to the study participant, Investigator and Sponsor with respect to 
bimagrumab and bimagrumab placebo and open label with respect to semaglutide.  Blinding will 
remain intact at least until database is locked for the Week 48 primary analysis.  Additional 
details regarding blinding and unblinding will be described in the SAP and a separate blinding 
and unblinding plan. 
6.4.1. 
Bimagrumab and Placebo  
All treatment arms are triple blinded with regards to bimagrumab and bimagrumab placebo 
(participants/Investigators, Sponsor). The IWRS will be programmed with blind-breaking 
instructions. In case of an emergency, the Investigator has the sole responsibility for determining 
if unblinding of a participants’ intervention assignment is warranted. Participant safety must 
always be the first consideration in making such a determination. If the Investigator decides that 
unblinding is warranted, the Investigator may, at the Investigator’s discretion, contact the 
Sponsor to discuss the situation prior to unblinding a participant’s intervention assignment unless 
this could delay emergency treatment for the participant. If a participant’s intervention 
assignment is unblinded, the Sponsor must be notified within 24 hours of this occurrence. The 
date and reason for the unblinding must be recorded. 
6.4.2. 
Semaglutide  
Because a placebo of semaglutide is not available for this study, the study cannot be double 
blinded to all semaglutide treatments. Therefore, participants assigned to a combination of 
semaglutide with bimagrumab or its placebo (approximately N=330) will be aware of their open 
label semaglutide dosage but blinded to the bimagrumab/placebo assignment and dosage. 
Potential bias will be reduced through central randomization. 
6.4.3. 
SAE and Unblinding  
Sponsor safety staff may unblind the intervention assignment for any participant with an SAE. If 
the SAE requires that an expedited regulatory report be sent to one or more regulatory agencies, 
a copy of the report, identifying the participant’s intervention assignment, may be sent to 
Investigators in accordance with local regulations and/or Sponsor policy. 
6.4.4. 
Unblinded Personnel  
With the exception of any unblinded site staff identified below, all site staff (including study 
Investigator and study nurse) will be blinded to study treatment throughout the study. 
Unblinded study personal will include: 
 Unblinded site pharmacist or pharmacy staff 
 Unblinded study monitor 
Bimagrumab and its placebo will be supplied as bulk in boxes containing 3 vials per box. An 
unblinded pharmacist or other qualified trained personnel, who is independent of the study team, 
will be required to prepare study drug bags for infusion. They are the only site level personnel 
who will have access to treatment assignments. 
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Appropriate measures must be taken by the unblinded pharmacist to ensure that the treatment 
assignments are concealed from the rest of the site staff. Any potential visible difference in 
treatments will be concealed by the use of an opaque sleeve. 
6.5. 
Study Intervention Compliance  
When the individual dose for a participant is prepared, the preparation of the dose will be 
confirmed by another unblinded study staff member. 
When participants are dosed at the site, they will receive study intervention directly from the 
Investigator or designee, under medical supervision. The date and time of each dose 
administered in the clinic will be recorded in the source documents. The dose of study 
intervention and study participant identification will be confirmed at the time of dosing by a 
member of the study site staff other than the person administering the study intervention. 
In treatment arms receiving semaglutide, when participants self-administer semaglutide at home, 
compliance with study intervention will be assessed at each visit. Compliance will be assessed 
by direct questioning, checking of participant diary, and return of all used and unused medication 
during the site visits and documented in the source documents and relevant form. Deviation(s) 
from the prescribed dosage regimen should be recorded. 
A record of the quantity of study interventions dispensed to and administered to/by each 
participant must be maintained and reconciled with study intervention and compliance records. 
Intervention start and stop dates, including dates for intervention delays and/or dose reductions 
will also be recorded. 
6.6. 
Dose Modification  
6.6.1. 
Bimagrumab  
No dose modification (up or down titration) of bimagrumab is allowed.  Interruption of dosing 
may be allowed for safety reasons (see Section 7.1.1). 
6.6.2. 
Semaglutide  
Semaglutide is initiated at 0.25 mg once weekly for 4 weeks. Dose is increased in 4-week 
intervals until a dose of 2.4 mg is reached for the 2.4 mg dose arms and until 1.0 mg is reached 
for the 1.0 mg dose arms. 
If participants do not tolerate the maintenance 2.4 mg once-weekly dose, the dose can be 
temporarily decreased to 1.7 mg once-weekly, for a maximum of 4 weeks. After 4 weeks, 
semaglutide should be increased to the maintenance dose of 2.4 mg once weekly. 
If participants do not tolerate the planned dose-escalation schedule, they may drop back to the 
highest previously tolerated dose and extend that dose for an additional one week, and then re-
attempt dose escalation at least once. If the higher dose is not tolerated, the participant can step 
down and remain on the lower, highest-tolerated dose.  
 
 
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Management of Participants with BMI ≤22 kg/m2  
If …  
And.. 
Then …  
a participant has a BMI 
≤22 kg/m2 at any time 
during the study 
1) the participant has completed 
dose escalation with 
semaglutide 
2) dietary modifications to slow 
weight loss have been attempted  
the investigator should contact the sponsor 
to consider a dose reduction of 
semaglutide to the next lower maintenance 
dose level. 
body weight reduction 
continues to decline after 
30 days despite a dose 
reduction to the next lower 
maintenance dose level 
the investigator wants to consider 
discontinuing study intervention 
the investigator should contact the sponsor 
for further discussion. 
a participant has a 
BMI ≤18.5 
 
study intervention must be discontinued. 
Management of Participants with Perceived Excessive Body Weight Loss  
If BMI is not ≤22 kg/m2 but there are concerns that the degree of body weight reduction may 
lead to participant decision to discontinue from study intervention, the investigator should 
contact the sponsor to consider dose reduction to the next lower maintenance dose level. 
6.7. 
Continued Access to Study Intervention after the End of Treatment  
No access to study medication will be provided after completion of the study treatment period or 
post-treatment follow-up period. 
6.8. 
Treatment of Overdose  
6.8.1. 
Bimagrumab  
The Sponsor does not recommend specific treatment for an overdose of bimagrumab. 
6.8.2. 
Semaglutide  
Overdose of semaglutide should follow the standard directions as outlined in the package insert. 
6.9. 
Prior and Concomitant Therapy  
Any medication or vaccine (including over the counter or prescription medicines, recreational 
drugs, vitamins, and/or herbal supplements) that the participant is receiving at the time of 
enrolment or receives during the study must be recorded along with: 
 Reason for use 
 Dates of administration including start and end dates 
 Dosage information including dose and frequency 
The medical monitor should be contacted if there are any questions regarding concomitant or 
prior therapy. 
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6.9.1. 
Prohibited Medicine  
The table below lists medications which are prohibited from use for the study period. 
Table 4: 
Prohibited Medications 
Prohibited Medication 
Prohibition 
Period 
Action 
Anti-androgens 
12 weeks prior 
to Day 1 to EoS 
Report protocol deviation, if used 
>7 days discontinue the study 
Gonadotropin releasing hormone (GnRH) 
analogues 
12 weeks prior 
to Day 1 to EoS 
Report protocol deviation, if used 
>7 days discontinue the study 
Anabolic steroids (testosterone, danazol, 
oxandrolone, stanozolol etc.) except 
replacement doses in hypogonadal men. 
Hormone replacement therapy in women 
with the exception of low dose estrogen. 
12 weeks prior 
to Day 1 to EoS 
Report protocol deviation, if used 
>7 days discontinue the study 
Recombinant human growth hormone 
(rhGH), hGH receptor antagonist (e.g., 
pegvisomant), hGH releasing hormone 
agonist 
12 weeks prior 
to Day 1 to EoS 
Report protocol deviation, if used 
>7 days discontinue the study 
Oral beta-adrenergic agonists 
4 weeks prior to 
Day 1 to EoS 
Report protocol deviation, if used 
>14 days discontinue the study 
Systemic glucocorticoid (dexamethasone, 
hydrocortisone, methyl prednisolone, 
prednisolone, prednisone, triamcinolone) 
at doses > 10 mg/d prednisone-equivalent 
12 weeks prior 
to Day 1 to EoS 
Short term courses of systemic 
glucocorticoid treatment up to 14 
days is allowed (maximum, 2 
courses per year).  Report 
protocol deviation, if used >14 
days; discontinue the study if >2 
courses of short-term steroid. 
Anti-obesity medications, dietary 
supplements, dietary interventions other 
than described in the protocol, or over the 
counter products for weight loss. 
30 days prior to 
Day 1 to EoS 
Report protocol deviation, if used 
>30 days discontinue the study 
Any antidiabetic medication used to treat 
diabetes. Note: Metformin or SGLT2 
inhibitors are permitted if used for the 
treatment of metabolic syndrome. Insulin 
is allowed for up to one week at a time to 
correct for acute hyperglycemia. 
12 weeks prior 
to Day 1 to EoS 
Report protocol deviation, if used 
>7 days discontinue the study 
Any product or medication known or 
suspected to cause significant weight 
change (e.g., mirtazapine), in consultation 
with the medical monitor), unless on 
stable dose for at least 12 weeks prior to 
Day 1. 
12 weeks prior 
to Day 1 to EoS 
Report protocol deviation (unless 
specific medication allowed by 
medical monitor); if used >30 
days, discontinue the study 
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Prohibited Medication 
Prohibition 
Period 
Action 
Valproate 
12 weeks prior 
to Day 1 to EoS 
Report protocol deviation, if used 
>7 days discontinue the study 
6.9.2. 
Prohibited Non-Pharmacological Concomitant Treatments  
Bariatric surgery and use of Plenity® are prohibited for the study period. 
6.9.3. 
Recommended Treatment of Adverse Events  
Muscle symptoms can be addressed with light self-massage of the involved area concentrating 
on improving circulation and relaxing muscle tissue. If excessive or prolonged soreness presents, 
then acetaminophen can be used as needed. 
Acne may be treated with a face wash containing 4-10% benzoyl peroxide and over the counter 
topical treatments. If needed, a prescription topical treatment (e.g., antibiotic) or oral antibiotic 
(e.g., minocycline 100 mg bid) may be recommended at the Investigator’s discretion. Early 
intervention is recommended when acne presents. 
Diarrhea, nausea, vomiting, constipation may be treated with over-the-counter remedies. In 
cases of prolonged occurrence, other treatments may be used at the Investigator’s discretion. 
7. 
DISCONTINUATION OF STUDY INTERVENTION, 
PARTICIPANT DISCONTINUATION / WITHDRAWAL AND 
STUDY STOPPING / PAUSING  
7.1. 
Participant Discontinuation of Study Intervention  
In rare instances, it may be necessary for a participant to permanently discontinue study 
intervention. If study intervention is permanently discontinued during one of the treatment 
periods, the End of Treatment (EOT) visit should be conducted as soon as possible, followed by 
the End of Study (EOS) visit at least 12 weeks after last treatment with bimagrumab/placebo. 
Study treatment must be discontinued for an individual participant under the following 
circumstances: 
 Withdrawal of consent.
 An infusion reaction that is considered severe.
 One or more symptomatic hypoglycemic events necessitating third party rescue and 
suspected to be related to study drug.
 A serious adverse event (SAE) thought to be related to study drug.
 Use of prohibited treatment fulfilling the criteria in Table 4.
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 Pregnancy: a positive pregnancy test after start of study treatment requires immediate 
discontinuation of study treatment, even if confirmation testing is pending. In the 
event of pregnancy, report as described above.  
 Any protocol deviation that results in a significant risk to the participant’s safety.
 Emergence of one or more adverse events that in the judgment of the Investigator, 
considering the participant’s overall status, prevent the participant from safely 
continuing in the study. 
Investigational treatment may be discontinued under the following circumstances: 
 Breaking of the blind (inadvertently or for emergency reasons)
 Liver, pancreas, or muscle related adverse event as described in Sections 10.6, 10.7, 
and 10.8.
Participants who discontinue study treatment should NOT be considered withdrawn from the 
study UNLESS they withdraw their consent. They should return approximately 12 weeks after 
their last dose of bimagrumab/placebo for the End of Study visit as described above. If they fail 
to return for these assessments for unknown reasons, every effort should be made to contact them 
as specified in Section 7.3. 
7.1.1. 
Liver, Pancreas, or Muscle Related Events Stopping Criteria  
Study treatment may be interrupted or discontinued if a participant meets one of the conditions 
for liver, pancreas or muscle related adverse events, as outlined in the algorithms in 
Sections 10.6, 10.7, and 10.8, Appendices 6, 7, and 8, or if the Investigator believes it is in the 
best interest of the participant, even if the criteria are not met.  At the Week 4 and Week 64 
visits, participants’ safety lab results must be available and reviewed against the guidance in 
Appendices 6, 7, and 8 in advance of dose administration with bimagrumab/placebo. 
7.1.2. 
Temporary Discontinuation  
No temporary discontinuation is allowed except for management of adverse events, as described 
in Section 7.1.1. Refer to Section 6.6.2 if the current semaglutide dose cannot be tolerated, and 
for management of participants with BMI ≤22 kg/m2 or perceived excessive body weight loss. 
 
7.2. 
Participant Discontinuation/Withdrawal from the Study  
A participant may withdraw from the study at any time at the participant’s own request for any 
reason (or without providing any reason). 
A participant may be withdrawn at any time at the discretion of the Investigator for safety or 
compliance reasons. 
At the time of discontinuing from the study, if during one of the treatment periods, an “end of 
treatment” visit should be conducted as soon as possible, as described in Section 7.1.  Please see 
SoA Section 1.3 for data to be collected at the time of study discontinuation and follow-up for 
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any further evaluations needed for follow up of adverse events.  Participants should return at 
least 12 weeks after their last dose of bimagrumab/placebo for the End of Study visit. 
If the participant withdraws consent for disclosure of future information, the Sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. 
If a participant withdraws from the study, the participant may request destruction of any samples 
taken and not tested, and the Investigator must document this in the site study records. 
7.3. 
Lost to Follow-up  
A participant will be considered lost to follow-up if the participant repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
 The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible, counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether the participant wishes to and/or should 
continue in the study. 
 Before a participant is deemed lost to follow-up, the Investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls, and if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods). These contact attempts should be documented 
in the participant’s medical record. 
 Should the participant continue to be unreachable, the participant will be considered 
"lost to follow-up”. 
7.4. 
Treatment Arm and Study Stopping/Pausing Rules  
The study will be paused and no further dosing and/or new recruitment will occur pending full 
safety review by the DMC, if any of the below criteria are met. After a safety review by the 
DMC, the DMC will recommend to the sponsor either to continue the study, to stop an arm or to 
stop the study. The study may resume following the safety review, if the DMC and Sponsor 
agree it is safe to proceed and necessary approvals have been obtained from authorities according 
to local regulations. 
 Any death considered to be related to study treatment. 
 Two or more participants experience a TESAEs of a similar type (other than death, 
corresponding to NCI-CTCAE grade 3 or higher) considered to be related to blinded 
study treatment, unless expected per Reference Safety Information. 
 One or more participants develop a life-threatening (NCI-CTCAE grade 4) or fatal 
acute allergic reaction within 24 hours following study treatment administration (i.e., 
active drug/placebo), unless clearly caused by exposure to a known allergen (e.g., 
peanut allergy). 
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 Two or more participants are discontinued due to a liver event as defined in 
Section 10.6 Appendix 6. 
 Number and/or severity of AEs, abnormal safety monitoring tests, or abnormal 
laboratory findings justify putting the study on hold. 
 The Sponsor unilaterally requests a stoppage. 
8. 
STUDY ASSESSMENTS AND PROCEDURES  
Study procedures and their timing are summarized in the SoA Section 1.3. Protocol waivers or 
exemptions are not allowed. Visits should be performed as close to the planned timepoint as 
possible, with a visit window of +/- 7 days, with the following exceptions: 
 All required Screening assessments must be completed within Week -6 and Day -1.  
Any screening assessments that are outside of this range may be repeated once 
without screen failing. 
 For the baseline visit, DXA scans may be performed up to 14 days prior to the 
baseline visit. For all other visits, the DXA assessment window is -2 weeks to +1 
week of the scheduled time. 
 
 (Week 4) and 
 (Week 64) dosing should be performed within a visit 
window of -2 to +14 days. 
Adherence to the study design requirements, including those specified in the SoA Section 1.3, is 
essential and required for study conduct. 
All screening evaluations must be completed and reviewed to confirm that potential participants 
meet all eligibility criteria. The Investigator will maintain a screening log to record details of all 
participants screened and to confirm eligibility or record reasons for screening failure, as 
applicable. 
":7+-,=:-;+76,=+<-,);8):<7.<0-8):<1+18)6<J;:7=<16-+4161+)45)6)/-5-6<(e.g., complete 
blood count) and obtained before signing of the ICF may be utilized for screening or baseline 
purposes provided the procedures met the protocol-specified criteria and were performed within 
the timeframe defined in the SoA Section 1.3. 
In the event of a significant study-continuity issue (e.g., caused by a pandemic), alternate 
strategies for participant visits, assessments, medication distribution and monitoring may be 
implemented by the Sponsor or the Investigator, as per local health authority/ethics requirements. 
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples. 
8.1. 
Administrative Procedures  
Demographic and baseline characteristic data will include year of birth, sex, race, predominant 
ethnicity. 
Relevant medical history and current medical conditions will be recorded. Where possible, 
diagnoses but not symptoms will be recorded. Investigators have the discretion to record 
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abnormal test findings as medical history, if in their judgment, the test abnormality occurred 
prior to the informed consent signature. 
Disease history will include duration of obesity/overweight (number of years).  Obesity-related 
comorbidities will be recorded on the Medical History form, along with assessment of status of 
these at end of study. 
All current medications and significant non-drug therapies must be listed on the Concomitant 
medications eCRF. 
Urine drug screening will be performed, and the results kept as source data. 
Body height will be measured as described in the SOM. 
8.2. 
Efficacy / Pharmacodynamics Assessments  
Planned timepoints for all efficacy and pharmacodynamic assessments are provided in the SoA 
Section 1.3. Additional details of the methods to perform assessments are provided in the SOM. 
8.2.1. 
Anthropometric Measurements  
8.2.1.1. 
Body Weight  
Body weight will be measured in kilograms (kg) to the nearest 0.1 kg, in light indoor clothing, 
without shoes and on an empty bladder, using the scale provided by the Sponsor throughout the 
trial. 
8.2.1.2. 
Waist Circumference  
Waist circumference will be measured in standing position with a non-stretchable measuring tape 
and to the nearest 0.1 centimeter (cm).  The measurement should be taken with the participant 
standing and with the waist area unclothed. The tape should be positioned around the participant, 
parallel to the floor, with the lower edge of the tape at the level of the posterolateral superior iliac 
crest bilaterally and the circumference measured at the end of a normal expiration. 
The same type of measuring tape should be used throughout the trial. The measuring tape will be 
provided by the Sponsor to ensure standardization. 
8.2.1.3. 
Body Mass Index  
BMI will be calculated in the electronic case report form (eCRF) using the following formula: 
 
BMI = Body weight (kg) / [Height (m)]2 
8.2.1.4. 
Bioelectrical Impedance Analysis  
Bioelectrical impedance analysis (BIA) is a widely used method for estimating body 
composition. The technology is relatively simple, quick, and noninvasive. BIA is currently used 
in diverse settings, including private clinicians’ offices, health clubs, and hospitals, and across a 
spectrum of ages, body weights, and disease states. An estimate of total body water (TBW) is 
derived by measuring electrical impedance of body tissues, from which fat-free mass (FFM), 
lean (muscle) mass, and body fat (adiposity) are estimated. 
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8.2.2. 
DXA Scan  
Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition, 
including total fat and lean body mass (FBM and LBM), trunk fat mass, visceral adipose tissue 
(VAT), subcutaneous adipose tissue (SAT), and bone mineral density (total body, lumbar spine, 
hip). 
Quality assurance is an important issue in the use of DXA scans to determine body composition. 
DXA instrument manufacturer and model should remain consistent, and their calibration should 
be monitored throughout the study. Use of a standardized scan acquisition protocol and 
appropriate and unchanging scan acquisition and analysis software is essential to achieve 
consistent results. Likewise, because of variability in interpretation of the scans, it is important to 
utilize centralized scan analysis by experienced staff. 
Data collection and processing is explained in the Imaging Manual written and provided by 
the imaging CRO. DXA scans will be sent to the imaging CRO for central reading. Results must 
remain blinded to Investigator and participant until database lock, however medically significant 
incidental findings (e.g., tumor) not related to the study analyses can be disclosed to the 
Investigator as appropriate for the medical care of the participant. 
8.2.4. 
Impact of Weight on Quality of Life-Lite Clinical Trials Version  
The IWQOL-Lite CT is a 20-item modified survey instrument that is used to quantitatively 
);;-;;)616,1>1,=)4J;8-:+-8<176of how their weight affects their day-to-day life [34]. The LITE 
CT version has been specifically developed for clinical trials. The physical function score will 
also be evaluated.  This instrument is especially valuable to validate the effectiveness of the 
treatment for obesity using metrics that go beyond the physical measurements of weight loss. 
8.2.5. 
Short Form (SF-36) Health Survey  
SF-36 measures a participantJ;7>-:)440-)4<0:-4)<-,9=)41<A7.41.-<1;)-item generic 
measure of health status that yields 2 summary scores for physical health and mental health, and 
8 domain scores [35]. The physical functioning score will also be evaluated. 
8.2.6. 
Physical Activity Monitoring Via 
  
The Investigator must encourage American Diabetes Association walking guidelines (at least 
150 minutes of physical activity per week). Daily steps and general activity levels will be 
monitored by a wrist worn 
 device provided to participants by the Sponsor. 
8.2.6.1. 
Lipid Profile  
Blood samples for total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides will be 
collected under fasting conditions, unless specified otherwise. These parameters will be 
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measured by the local lab at screening and by the central laboratory at Sponsor determined 
timepoints. 
8.2.6.2. 
Glucose Metabolism Parameters: HbA1c, Fasting Insulin and Glucose  
With the exception of the screening visit, samples for insulin and glucose will be collected 
under fasting conditions. Glucose will be measured by the local lab for safety. HbA1c and 
fasting insulin will be measured by the central laboratory, per the study’s Laboratory Manual, at 
timepoints indicated in the SoA Section 1.3. 
The Homeostatic model assessment 2 – insulin resistance index (HOMA-IR) and the quantitative 
insulin-sensitivity check index (QUICKI) are derived insulin resistance indexes that will be 
calculated by data management. 
8.3. 
Safety Assessments  
Planned timepoints for all safety assessments are provided in the SoA Section 1.3. Details of the 
methods to perform assessments are provided in the SOM. 
8.3.1. 
Physical Examinations  
A complete physical examination will be performed at all listed visits and will include the 
examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lungs, 
heart, abdomen, back, lymph nodes, extremities, vascular, and neurological systems. If indicated 
based on medical history and/or symptoms, additional exams may be performed. 
Skin assessment should include findings of new, or worsening, and significant acne or skin 
lesions. 
For males, a bilateral assessment and measurement of gynecomastia (breast tissue diameter) will 
be made, if present. 
Investigators should pay special attention to clinical signs related to previous serious illnesses 
and to those listed under “Warnings and precautions” for Wegovy® or Ozempic®. 
8.3.2. 
Vital Signs  
Temperature, pulse rate, and blood pressure will be recorded (before blood collection for 
laboratory tests). 
Blood pressure and pulse rate measurements will be assessed in a sitting position with a 
completely automated device. Manual techniques will be used only if an automated device is not 
available or not suitable for the participant. 
Blood pressure and pulse rate measurements should be preceded by at least 5 minutes of rest for 
the participant in a quiet setting without distractions (e.g., television, cell phones). 
If a blood pressure measurement is out of range, it may be repeated once, after the participant has 
rested for at least 5 minutes. 
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8.3.3. 
Electrocardiograms  
A standard 12-lead ECG will be performed with the participant in a supine position, using an 
ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF 
intervals. Interpretation of the tracing must be made by a qualified physician and documented on 
the ECG and in the ECG section of the eCRF. 
Each ECG tracing should be labeled with the study number, participant initials, participant 
number and date, and kept in the source documents at the study site. Clinically significant 
abnormalities should be recorded on the relevant medical history eCRF page prior to informed 
consent signature and on the Adverse Events page thereafter. Clinically significant findings must 
be discussed with the Sponsor. 
The eCRF will contain the date and time of ECG, PR and RR intervals, QT interval, QTcF, and 
QRS duration. 
The Fridericia QT correction formula (QTcF) should be used for clinical decisions. 
Unless auto calculated by the ECG machine, the Investigator must calculate QTcF. See the Site 
Operations Manual for additional details. 
Original ECG tracings, appropriately signed, will be archived at study site. 
8.3.4. 
Clinical Safety Laboratory Tests  
All protocol-required safety lab tests, as defined in Section 10.2 Appendix 2, must be conducted 
in accordance with the SoA Section 1.3. 
The Investigator must review the laboratory results, document this review, and record any 
clinically significant changes occurring during the study as an AE. 
Abnormal laboratory findings associated with the underlying disease are not considered 
clinically significant unless judged by the Investigator to be more severe than expected for the 
participant’s condition. 
All laboratory tests with values considered clinically significantly abnormal during participation 
in the study or until 30 days from the EOS visit should be repeated until the values return to 
normal or baseline or are no longer considered clinically significant by the Investigator or 
medical monitor. Additional guidance for the follow up of abnormal liver and pancreas tests, as 
well as elevated CK, is provided in the safety monitoring section of this protocol and 
Sections 10.6, 10.7, and 10.8, Appendices 6, 7, and 8. 
If clinically significant values do not return to normal/baseline within a period judged reasonable 
by the Investigator, the etiology should be identified, and the Sponsor notified. 
If laboratory values from non-protocol-specified laboratory tests performed at the institution’s 
local laboratory require a change in participant management or are considered clinically 
significant by the Investigator (e.g., SAE or AE or dose modification), then the results must be 
recorded. 
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8.3.5. 
Pregnancy Testing  
Serum pregnancy test is required for all female participants at screening and for confirmation of 
any positive urine pregnancy test. 
For all other visits, urine dipstick pregnancy testing will be required for pre-menopausal female 
participants, unless serum is required based on local requirements. Women surgically sterilized 
(but pre-menopausal) are still required to complete pregnancy tests. In case urine dipstick 
pregnancy test is positive, it must be confirmed with a serum pregnancy test prior to dosing. All 
positive urine tests will be followed up by a serum test. 
A negative test result is required prior to receiving any study medication. 
Additional serum or urine pregnancy tests may be performed, as determined necessary by the 
Investigator, or required by local regulation, to establish the absence of pregnancy at any time 
during the participant’s participation in the study. 
8.3.6. 
Hematology/Coagulation  
Hemoglobin, hematocrit, red blood cell count, RBC indices, white blood cell count with 
differential (e.g., neutrophils, basophils, eosinophils, monocytes, lymphocytes), erythrocyte 
sedimentation  rate, platelet count, aPTT, and PT/INR will be measured. 
8.3.7. 
Blood Chemistry  
Blood chemistry should be assessed after a fast of approximately 8 hours. Blood chemistry will 
include sodium, potassium, calcium, magnesium, bicarbonate/CO2, chloride, phosphate or 
phosphorus, creatinine, BUN or urea, glucose, uric acid, albumin, total protein, alkaline 
phosphatase, total and direct bilirubin, LDH, GGT, AST, ALT, amylase, lipase, and CK. 
If the total bilirubin concentration is increased above 1.5x ULN, direct and indirect bilirubin 
should be obtained. 
Additional safety labs may be performed at the Investigator’s discretion for any 
clinically/medically significant abnormalities. 
8.3.8. 
Urinalysis and Urine Chemistry  
A midstream urine sample (approx. 30 mL) will be obtained in order to avoid contamination with 
epithelial cells and sediments and to allow proper assessment. Required assessments include 
occult blood, pH, specific gravity, ketones, glucose, protein, bilirubin, nitrite and leukocytes. A 
microscopic examination will be performed if blood or protein are abnormal.  The sample will 
also be used for measurement of urine microalbumin and urine creatinine, for calculation of 
urine albumin:creatinine ratio (ACR). 
8.4. 
Adverse Events, Treatment Emergent Adverse Events, Serious 
Adverse Events, and Other Safety Reporting  
The definitions of AEs, TEAEs, and SAEs unsolicited and solicited adverse events can be found 
in Section 10.3 Appendix 3. 
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The Investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible for following 
up all AEs. This includes events reported by the participant (or, when appropriate, by a 
caregiver, surrogate, or the participant’s legally authorized representative). 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Section 10.3 
Appendix 3. 
8.4.1. 
Time Period and Frequency for Collecting AE, TEAE and SAE Information  
All SAEs will be collected from the time of the signature of the informed consent until the EoS 
visit and will be recorded in the database for all randomized participants.  Non-serious adverse 
events will be collected from the time of first dose of study medication(s) until the EoS visit 
(treatment-emergent adverse events [TEAEs]).  Non-serious medical conditions identified during 
the screening period should be recorded as medical history. 
The Investigator will record and report all SAEs to the Sponsor or designee immediately and 
under no circumstance should this exceed 24 hours, as indicated in Section 10.3 Appendix 3. The 
Investigator will submit any updated SAE data to the Sponsor within 24 hours of it being 
available. 
Investigators are not obligated to actively seek information on AEs or SAEs after conclusion of 
the study participation. However, if the Investigator learns of any SAE, including a death, at any 
time after a participant has been discharged from the study, and the Investigator considers the 
event to be reasonably related to the study intervention or study participation, the Investigator 
must promptly notify the Sponsor. 
8.4.2. 
Follow-up of AEs and SAEs  
After the initial AE/SAE report, the Investigator is required to proactively follow each 
participant at subsequent visits/contacts. All SAEs and AEs of special interest (as defined in 
Section 8.4.5) will be followed until resolution, stabilization, the event is otherwise explained, or 
the participant is lost to follow-up (as defined in Section 7.3). Further information on follow-up 
procedures is provided in Section 10.3 Appendix 3. 
8.4.3. 
Regulatory Reporting Requirements for SAEs  
Prompt notification by the Investigator to the Sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a study 
intervention under clinical investigation are met. 
The Sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
Sponsor will comply with country-specific regulatory requirements relating to safety reporting to 
the regulatory authority, institutional review boards (IRBs)/independent ethics committees 
(IECs), and Investigators. 
An Investigator who receives an Investigator Notification/Safety Report describing an SAE or 
other specific safety information (e.g., summary or listing of SAEs) from the Sponsor will 
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review and then file it along with the IB/package insert and will notify the IRB/IEC, if 
appropriate according to local requirements. 
Investigator Notification/Safety Reports must be prepared for suspected unexpected serious 
adverse reactions (SUSARs) according to local regulatory requirements and Sponsor policy and 
forwarded to all participating Investigators. 
8.4.4. 
Pregnancy  
Details of all pregnancies in female participants, or in female partners of male participants, 
occurring in the study and until 4 months after the last dose of study drug (if the participant was 
on active drug) will be collected to determine the outcome of the pregnancy. The Investigator 
will collect the follow-up information on the participant and the neonate and forward the 
information to the Sponsor. 
If a pregnancy is reported or detected, the Investigator will record pregnancy information on the 
appropriate form and submit it to the Sponsor within 24 hours of learning of the pregnancy. 
While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or 
elective termination of a pregnancy for medical reasons will be reported as an AE or SAE. 
Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs and will be reported as such. 
Any post-study pregnancy-related SAE considered reasonably related to the study intervention 
by the Investigator will be reported to the Sponsor as described in Section 8.4.4. While the 
Investigator is not obligated to actively seek this information in former study participants, he or 
she may learn of an SAE through spontaneous reporting. 
Any female participant who becomes pregnant or has a positive pregnancy test while 
participating in the study must discontinue study intervention immediately. 
8.4.5. 
Treatment Emergent Adverse Events of Special Interest  
Adverse events of special interest (AESI) for bimagrumab are defined based on an ongoing 
review of all safety data and include (using CTCAE intensity grading): 
 Muscle related events (e.g., rhabdomyolysis, muscle spasm, cramps, twitching, 
tightness) [at least grade 3] 
 Skin lesions (e.g., acne, growths) [at least grade 3] 
 Pancreatitis 
 Gastrointestinal events (e.g., diarrhea, nausea) [at least grade 3] 
 Malignancy  
8.5. 
Pharmacokinetics  
Serum bimagrumab and plasma semaglutide concentrations (as applicable) will be evaluated in 
samples collected from all participants according to the SoA Section 1.3. 
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Each serum/plasma sample will be divided into 2 aliquots (1 for analysis and another for 
backup). Samples collected for analyses of bimagrumab concentration and semaglutide 
concentration may also be used to evaluate safety or efficacy aspects related to concerns arising 
during or after the study. 
Instructions for the collection and handling of biological samples will be provided in the 
laboratory manual.  Post-bimagrumab samples should be targeted for collection 15 minutes after 
the end of the post-infusion flush, but no later than 45 minutes after the completion of the flush. 
Bimagrumab and serum concentration information will not be reported to investigative sites or 
blinded personnel until the study has been unblinded. 
Information on storage and future use of samples is detailed in Section 10.1.5.1. 
8.6. 
Pharmacodynamics  
8.7. 
Genetics  
A 10 mL blood sample for DNA isolation will be collected at the baseline visit from participants 
who have consented to participate in the genetic analysis component of the study. Participation is 
optional. Participants who do not wish to participate in genetic research may still participate in 
the study. 
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In the event of DNA extraction failure, a replacement genetic blood sample may be requested 
from the participant. Signed informed consent will be required to obtain a replacement sample 
unless it was included in the original consent. 
Instructions for the collection and handling of biological samples will be provided in the 
laboratory manual. 
See Section 10.5 Appendix 5 Genetics for information regarding genetic research. 
Information on storage and future use of samples is detailed in Section 10.1.5.1. 
8.8. 
Immunogenicity Assessments  
Serum samples from all participants collected according to the SoA will be screened for 
antibodies binding to bimagrumab (anti-drug-antibodies, ADA) and the titer of confirmed 
positive samples will be reported. Other analyses may be performed to evaluate the neutralizing 
activity or verify the stability of antibodies to bimagrumab and/or further characterize the 
immunogenicity of bimagrumab. 
Instructions for the collection and handling of biological samples will be provided in the 
laboratory manual. 
Results will not be reported to investigative sites or blinded personnel until the study has been 
unblinded. 
Information on storage and future use of samples is detailed in Section 10.1.5.1. 
9. 
STATISTICAL CONSIDERATIONS  
The statistical analysis plan (SAP) will be finalized prior to the primary efficacy analysis (e.g., 
when participants complete Week 48) and it will include a more technical and detailed 
description of the endpoints to be summarized and the statistical analyses described in this 
section. This section is a summary of the planned statistical analyses of the key endpoints, 
subject to possible modifications in the final SAP. 
9.1. 
Statistical Analyses  
The primary objective is to assess the effect of varying doses of bimagrumab, semaglutide and 
bimagrumab in addition to semaglutide on body weight after 48 weeks of treatment.  Change in 
body weight is the primary outcome to be analyzed.  The proportion of participants in each 
treatment group who achieve )?-1/0<47;;7.
7>-:<0-+7=:;-7.<:-)<5-6<?144also be 
summarized and compared to control.  A viable treatment outcome will be one that shows either: 
 The difference in mean weight loss between the active-product and placebo-treated 
groups is at least % and the difference is statistically significant, 
or 
 The proportion of participants who lose greater than or equal to % of baseline body 
weight in the active-product group is at least 
%, is approximately 
 the proportion 
in the placebo-treated group, and the difference between groups is statistically significant. 
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The FDA guidance for phase 3 clinical trials in weight management recommends that in general, 
a product can be considered effective for weight management if after 1 year of treatment either 
of the following occurs: 
 The difference in mean weight loss between the active-product and placebo-treated 
groups is at least  percent and the difference is statistically significant 
or 
 The proportion of participants who lose greater than or equal to  percent of baseline 
body weight in the active-product group is at least 
 percent, is approximately 
 
the proportion in the placebo-treated group, and the difference between groups is 
statistically significant. 
For phase 2 clinical trials, the FDA guidance states that primary efficacy endpoints should 
include a comparison of the mean absolute or percent change in body weight between the active-
product and placebo-treated groups. 
All randomized participants who received at least one dose of study medication will be included 
in an intention-to-treat population (treatment policy strategy). Baseline and efficacy results will 
be summarized by randomized treatment arm, with active treatment arms compared to placebo, 
and combination treatment arms to each monotherapy of the same dose. 
The analyses to be performed will be similar to the primary analysis described above.  Details of 
these analyses will be provided in the SAP. 
9.1.1. 
Multiplicity Adjustment  
No multiplicity adjustment will be performed for this study. 
9.2. 
Analysis Sets  
For the purposes of statistical analysis and data summaries, the following analysis sets are 
defined: 
Analysis Set 
Description 
Full analysis set (FAS) 
1. All participants who meet eligibility criteria, sign the informed 
consent and are randomized to a treatment arm, regardless of 
exposure to investigational products, are included in the FAS. 
Safety analysis set (SAF) 
2. All participants who meet the definition of FAS and who are 
exposed to at least one dose of investigational products (including 
placebo) are included in the SAF. 
The FAS will be used to summarize demographics and baseline characteristics and analyze 
endpoints related to the efficacy objectives. Participants will be grouped in summaries and 
included in the analyses according to the planned investigational intervention. 
The SAF will be used to summarize and analyze the endpoints relate to safety and tolerability. 
Participants will be grouped in summaries and included in the analyses according to the highest 
dose level of investigational products they actually received. 
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9.3. 
Interim Analysis  
An interim analysis (IA) will be conducted when approximately 
% of the participants 
complete the Week 24 visit. The interim analysis will evaluate efficacy as well as the safety 
profile of both the combination and monotherapy treatment arms, and may be used to help 
determine the doses of bimagrumab to be used in future studies. 
9.4. 
Treatment Extension and Post-Treatment Follow-Up Period 
Analyses  
There will be no contemporaneous placebo/no treatment group with data through the extension 
phase since all participants originally enrolled into the placebo/no treatment arm will be switched 
to 30 mg/kg bimagrumab.  Likewise, all participants originally enrolled into the 10 mg/kg 
bimagrumab arm will switch to 30 mg/kg bimagrumab.  All other arms will remain unchanged.  
As a result, the maximum placebo response will be considered the response at the end of the core 
phase (48 weeks).  Analyses and summaries of treatment effect will continue to be based on the 
original randomization assignments. Analyses and summaries of treatment effect at 72 weeks 
will be provided.  
After 72 weeks, all participants remaining in the study will be withdrawn from treatment and 
followed for an additional 24 weeks.  Analyses and summaries of withdrawal effect will be 
provided.  
Details of analysis methods will be presented in an SAP for the extension phase. 
9.5. 
Sample Size Determination  
 participants will be randomized to 1 of 9 treatment groups. The sample size 
calculation is based on the primary efficacy estimand for weight.  Based on the FDA guidance on 
treatment for weight management, the minimum meaningful treatment effect for weight loss is 
5% of baseline body weight over 1 year of treatment.  Assuming the minimum treatment effect 
of % weight loss (approximately 5 kg) with a standard deviation (SD) of , for a minimum 
effect size of 
  [2, 3], a sample size of 
 participants per treatment arm will have 
approximately 
% statistical power to detect a treatment difference between any active group 
and placebo/no treatment using a 2-sided t-test at alpha
.  Assuming a 
% dropout rate, 
enrollment will target 
 participants per treatment arm. 
Sample size was estimated using a t-test for 2 means in NQuery Advisor V9.1 
(www.statsols.com). [4, 5]. 
 
 
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10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS   
10.1. 
APPENDIX 1: Regulatory, Ethical, and Study Oversight 
Considerations  
10.1.1. 
Regulatory and Ethical Considerations  
This study will be conducted in accordance with the protocol and with the following: 
 Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) international ethical guidelines 
 Applicable ICH Good Clinical Practice (GCP) guidelines 
 Applicable laws and regulations 
The protocol, protocol amendments, ICF, Investigator’s brochure, and other relevant documents 
(e.g., advertisements) must be submitted to an IRB/EC by the Investigator and reviewed and 
approved by the IRB/IEC before the study is initiated. 
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants. 
Protocols and any substantial amendments to the protocol will require health authority approval 
prior to initiation except for changes necessary to eliminate an immediate hazard to study 
participants. 
The Investigator will be responsible for the following, as applicable: 
 Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC. 
 Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures. 
 Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/EC, and all other applicable local 
regulations. 
10.1.2. 
Financial Disclosure  
Investigators and sub-Investigators will provide the Sponsor with sufficient, accurate financial 
information as requested to allow the Sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
responsible for providing information on financial interests during the study and for 1 year after 
completion of the study. 
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10.1.3. 
Informed Consent Process  
The Investigator or the Investigator’s representative will explain the nature of the study, 
including the risks and benefits, to the potential participant and answer all questions regarding 
the study. 
Potential participants must be informed that their participation is voluntary. They will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, local 
regulations, ICH guidelines, privacy, and data protection requirements, where applicable, and the 
IRB/IEC or study center. 
The medical record must include a statement that written informed consent was obtained before 
the participant was enrolled in the study and the date the written consent was obtained. The 
authorized person obtaining the informed consent must also sign the ICF. 
Participants must be reconsented to the most current version of the ICF(s) during their 
participation in the study. 
A copy of the ICF(s) must be provided to the participant. Participants who are rescreened are 
required to sign a new ICF. 
10.1.4. 
Recruitment Strategy  
Recruitment into the study will be via the clinical Investigator sites’ patient database, new 
referrals. Advertisements for the study may also be used, following EC/IRB approval. 
10.1.5. 
Data Protection  
Participants will be assigned a unique identifier by the Sponsor. Any participant records or 
datasets that are transferred to the Sponsor will contain the identifier only; participant names or 
any information which would make the participant identifiable will not be transferred. 
The participant must be informed that their personal study-related data will be used by the 
Sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant who will be required to give consent for their data to be used as 
described in the informed consent. 
The participant must be informed that their medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the Sponsor, and by 
inspectors from regulatory authorities. 
The contract between Sponsor/designee and study sites specifies responsibilities of the parties 
related data protection, including handling of data security breaches and respective 
communication and cooperation of the parties. 
Information technology systems used to collect, process, and store study-related data are secured 
by technical and organizational security measures designed to protect such data against 
accidental or unlawful loss, alteration, or unauthorized disclosure or access. 
10.1.5.1. Future Use of Stored Specimens and Data  
Any residual samples remaining after the protocol-defined analysis has been performed may be 
used for additional exploratory analysis of similar kind. For example, samples analyzed for 
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enzyme or hormone levels may indicate a need for further isozyme or related hormone analyses 
to better understand the results. These results may be included in the clinical study report. 
Future use may also include, but is not limited to, using residual samples for analytical purposes 
(e.g., to cross check between different sites and/or for stability assessment). Given the 
exploratory nature of the work, the analytical method used for those assessments may not be 
validated. As such, the results from this exploratory analysis will not be included in the clinical 
study report. 
The Sponsor may store samples for up to 15 years after the end of the study to achieve study 
7*2-+<1>-;,,1<176)44A?1<08):<1+18)6<;J+76;-6<;)584es may be used for further research by 
the Sponsor or others such as universities or other companies to contribute to the development of 
related or new treatments or research methods. 
During the conduct of the study, an individual participant can choose to withdraw consent to 
have biological specimens stored for future research. However, withdrawal of consent regarding 
biosample storage may not be possible after the study is completed. 
10.1.6. 
Data Safety Committee  
Participant safety will be continuously monitored by the site Investigator and medical monitor, 
which includes safety signal detection at any time during the study. 
In addition, an early aggregated safety data review will be performed by the DMC, the goal of 
which is to ensure no emerging safety trends. An initial safety review for this study is planned 
for the first 
% of participants who are dosed and have provided safety data for at least 
 days 
after administration of the first dose. Enrollment will not be paused during the review. 
Thereafter, the DMC will meet periodically, with ad hoc meetings as necessary. 
The committee will consist of at least 2 independent clinicians, knowledgeable in bariatric 
treatment, and 1 biostatistician. Prior to initiating enrollment, a DMC charter will be drafted and 
approved by the committee members. The primary role of the DMC is to advise on study 
conduct that will ensure participant safety. This may include recommendations to discontinue a 
specific treatment arm that appears to be showing characteristics of intolerance, or the study as a 
whole.  Unblinded data may be provided to the DMC in accordance with the DMC charter. 
Although the DMC may make recommendations to the Sponsor about changes in the conduct of 
the study, final decisions will be made by the Sponsor. In the case of early termination, 
consultation with Health Authorities may be required. 
Members of the DMC will not share any unblinded or semi-blinded information with anyone 
outside of the DMC. Particularly, the Sponsor blinded team members will remain fully blinded 
to any results throughout the study unless the DMC recommends changes in the conduct of the 
study (for example, early termination due to negative safety findings). 
An independent statistical reporting team not involved in the conduct of the studies will prepare 
the information for the DMC according to the specifications from the DMC statistician. The 
main tasks may include: 
 Generation of blinded and/or unblinded outputs for the DMC, including tables, 
figures, and listings, as  required.
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 Preparation of any other reports requested by the DMC during the closed session.
 Review of the data reports before sending to the DMC.
10.1.7. 
Site Monitoring  
Before an investigational site can enroll participants into the study, the Sponsor or designee 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 applicable regulations. This will be documented in a Clinical 
Study Agreement between the Sponsor/designee and the Investigator. 
 Sites which have been qualified for a previous Sponsor study within the past 2 years 
or sites participating in low-risk studies, do not need an onsite visit and may be 
qualified remotely. 
During the study, the Sponsor or designee 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 and that data are 
being accurately recorded in the case report forms. 
 Perform source data verification. This includes a comparison of the data in the case 
report forms with the participant’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 participant (e.g., clinic charts). 
 Record and report any protocol deviations not previously sent to the 
Sponsor/designee. 
 Confirm AEs and SAEs have been properly documented on eCRFs and confirm any 
SAEs have been forwarded to the Sponsor/designee and those SAEs that met criteria 
for reporting have been forwarded to the IRB. 
The monitor will be available between visits if the Investigator(s) or other staff needs 
information or advice. 
10.1.8. 
Clinical Monitoring  
Clinical site monitoring is conducted to ensure that the rights and well-being of trial participants 
are protected, that the reported trial data are accurate, complete, and verifiable, and that the 
conduct of the trial is in compliance with the currently approved protocol/amendment(s), with 
International Conference on Harmonization Good Clinical Practice (ICH GCP), and with 
applicable regulatory requirement(s). 
Monitoring for this study will be performed by the CRO. 
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Details of clinical site monitoring are documented in the Clinical Monitoring Plan (CMP). The 
CMP describes in detail who will conduct the monitoring, at what frequency monitoring will be 
done, at what level of detail monitoring will be performed, and the distribution of monitoring 
reports. 
Independent audits may be conducted by Sponsor/designee to ensure monitoring practices are 
performed consistently across all participating sites and that monitors are following the CMP. 
10.1.9. 
Audits and Inspections  
Authorized representatives of the Sponsor, a regulatory authority, an Independent Ethics 
Committee or an Institutional Review Board 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, Good Clinical 
Practice guidelines of the International Conference on Harmonization, and any applicable 
regulatory requirements. The Investigator should contact the Sponsor immediately if contacted 
by a regulatory agency about an inspection. 
10.1.10. 
Data Quality Assurance  
 All participant data relating to the study will be recorded on printed or electronic 
eCRFs unless transmitted to the Sponsor or designee electronically (e.g., laboratory 
data). The Investigator is responsible for verifying that data entries are accurate and 
correct by physically or electronically signing the eCRF. 
 Guidance on completion of eCRFs will be provided. 
 The Investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source documents. 
 Monitoring details describing strategy, including definition of study critical data 
items and processes (e.g., risk-based initiatives in operations and quality such as risk 
management and mitigation strategies and analytical risk-based monitoring), 
methods, responsibilities, and requirements, including handling of noncompliance 
issues and monitoring techniques (central, remote, or on-site monitoring) are provided 
in the monitoring plan. 
 The Sponsor or designee is responsible for the data management of this study, 
including quality checking of the data. 
 The Sponsor assumes accountability for actions delegated to other individuals (e.g., 
contract research organizations). 
 Records and documents, including signed ICFs, pertaining to the conduct of this 
study must be retained by the Investigator for 20 years after study completion unless 
local regulations or institutional policies require a longer retention period. No records 
may be destroyed during the retention period without the written approval of the 
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Sponsor. No records may be transferred to another location or party without written 
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10.1.11. 
Data Handling and Recordkeeping  
Source Documents 
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the Investigator’s site. 
Data reported on the eCRF or entered in the eCRF that are transcribed from source documents 
must be consistent with the source documents or the discrepancies must be explained. The 
Investigator may need to request previous medical records or transfer records, depending on the 
study. Also, current medical records must be available. 
Definition of what constitutes source data, and its origin can be found in monitoring guidelines. 
The Investigator must maintain accurate documentation (source data) that supports the 
information entered into the eCRF. 
The Sponsor or designee will perform monitoring to confirm that data entered into the eCRF by 
authorized site personnel are accurate, complete, and verifiable from source documents; that the 
safety and rights of participants are being protected; and that the study is being conducted in 
accordance with the currently approved protocol and any other study agreements, ICH GCP, and 
all applicable regulatory requirements. 
The Investigator/study personnel will allow the Sponsor (or designee) and appropriate regulatory 
authorities access to these records. 
Data Collection and Electronic Case Report Form (eCRF) Completion 
The Investigator, or designee, will enter data from the clinic’s medical records and study source 
worksheets into an online electronic data capture (EDC) system. All study personnel will be 
trained and receive a password protected login. Sponsor designated monitors will perform 
clinical monitoring, including verification of eCRFs and the source documentation. 
Data entry should occur in a timely manner for accuracy, but especially for complying with 
regulations if an unanticipated or serious adverse event occurs (within 24 hours). If delays in 
entry occur frequently, a formal corrective plan will be established. 
Inspection of Records 
Sponsor/designee 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 participant charts and study source documents, and other records relative to study 
conduct. 
Retention of Records 
The Principal Investigator must maintain all documentation relating to the study for a period of 
up to 20 years after the end of the study. If it becomes necessary for the Sponsor or the 
Regulatory Authority to review any documentation relating to the study, the Investigator must 
permit access to such records. 
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10.1.12. 
 Study and Site Start and Closure  
Study Start 
The study start date is defined as the date when the first participant signs the informed consent. 
Study/Site Termination 
The Sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The Investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or Investigator may include but are 
not limited to: 
For study termination: 
 Discontinuation of further study intervention development. 
For site termination: 
 Failure of the Investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the Sponsor’s procedures, or GCP guidelines. 
 Inadequate or no recruitment (evaluated after a reasonable amount of time) of 
participants by the Investigator. 
 Total number of participants included earlier than expected. 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
Investigators, the IECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of the 
reason for termination or suspension, as specified by the applicable regulatory requirements. The 
Investigator shall promptly inform the participant and should ensure appropriate participant 
therapy and/or follow-up. 
10.1.13. 
Publication Policy  
The results of this study are expected to be published or presented at scientific meetings and in 
clinical study registries. 
The Sponsor will comply with the requirements for publication of study results. In accordance 
with standard editorial and ethical practice, the Sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data. In this case, a 
coordinating Investigator will be designated by mutual agreement. 
Authorship will be determined by mutual agreement and in line with the International Committee 
of Medical Journal Editors authorship requirements. 
 
 
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10.2. 
APPENDIX 2: Clinical Laboratory Tests  
The tests detailed in Table 5 will be performed by the safety lab (local or central, depending on 
region). 
Protocol-specific requirements for inclusion or exclusion of participants are detailed in Section 5 
of the protocol. 
Additional tests may be performed at any time during the study as determined necessary by the 
Investigator or required by local regulations. 
Table 5: 
Safety Laboratory Tests  
Laboratory Tests 
Parameters 
Hematology 
 Hemoglobin 
 Hematocrit 
 Red blood cell (RBC) count 
 RBC indices 
 
Mean corpuscular volume (MCV) 
 
Mean corpuscular hemoglobin (MCH) 
 
Mean corpuscular hemoglobin concentration (MCHC) 
 
Reticulocytes (% and absolute) 
 White blood cell (WBC) count with differential (% and absolute) 
 Neutrophils 
 
Lymphocytes 
 
Monocytes 
 
Eosinophils 
 
Basophils 
 
Erythrocyte sedimentation rate 
 
Platelet count 
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Laboratory Tests 
Parameters 
Clinical chemistrya 
 Sodium 
 Potassium 
 Chloride 
 Bicarbonate (CO2) 
 Phosphate 
 Magnesium 
 Calcium 
 Albumin 
 Total protein 
 Uric acid 
 Urea/Blood urea nitrogen (BUN) 
 Creatinine 
 Glucose 
 Creatine kinase (CK) 
 Lipase 
 Amylase 
 Liver function tests 
 
AST / SGOT 
 
ALT/ SGPT 
 
LDH 
 
GGT 
 
Alkaline phosphatase 
 Total and direct bilirubin 
Urinalysis and urine 
chemistry 
 pH, specific gravity, glucose, protein, bilirubin, nitrite, and leukocytes, 
blood, ketones by dipstick 
 Microscopic examination (if blood or protein is abnormal) 
 Microalbumin, urine creatinine, albumin creatine ratio (calculated) 
Pregnancy testing 
 Serum (for all women at screening and to confirm a positive urine test) 
 Rapid urine human chorionic gonadotropin (hCG) pregnancy test (for 
all other visits)  
Coagulation 
parameters 
 aPTT, PT/INR 
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Laboratory Tests 
Parameters 
Screening only tests 
 Total cholesterol 
 Triglycerides 
 HDL cholesterol 
 LDL cholesterol 
 HbA1C 
 Follicle-stimulating hormone (FSH) for post-menopausal women 
 Urine drug screen (to include at minimum: amphetamines, 
barbiturates, cocaine, opiates, cannabinoids and benzodiazepines) 
 Thyroid-stimulating hormone (TSH), conducted unless a normal value 
is documented within 6 months prior to screening 
 HIV antibody, HBsAg, HCVAb 
a Details of liver, pancreas, and CK chemistry stopping criteria and required actions and follow-up are given in 
Sections 10.6, 10.7, and 10.8 (Appendices 6, 7, and 8), respectively. 
Investigators must document their review of each laboratory safety report. 
The tests detailed in Table 6 will be performed by the central lab. A list of potential biomarkers 
to be analyzed by the central lab may include, but is not limited to, those in Table 6.  These 
results may not be reported to the Investigator until the end of the study. 
Table 6: 
Other Laboratory Tests (Central Lab) 
Laboratory Tests 
Parameters 
Adipokines 
 Leptin 
 Adiponectin 
 Adipsin 
Fasting lipid profile 
 Total cholesterol 
 HDL cholesterol 
 LDL cholesterol 
 Triglycerides 
Inflammation 
biomarkers 
 IL-6 
 IL-18 
 hsCRP 
 NGAL 
Endocrine biomarkers  FSH 
 Estradiol 
 Free testosterone 
 Insulin 
 HbA1c 
 Serum CTX 
 BSAP 
 P1NP 
TGF-β superfamily 
biomarkers 
 Activins (TBD) 
 GDFs (TBD) 
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Immunogenicity 
 Anti-drug antibodies (ADA) to bimagrumab 
Safety biomarkers 
 ALP isoenzymes 
 Amylase isoenzymes 
 Lipase isoenzymes 
 5’NT 
 miR-122 
 CCK18 
 
 
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10.3. 
APPENDIX 3: AEs and SAEs: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting  
10.3.1. 
Definition of AE  
AE Definition 
 An AE is any untoward medical occurrence in a clinical study participant, temporally 
associated with the use of study intervention, whether or not considered related to the 
study intervention. 
 NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study intervention. 
Definition of Unsolicited and Solicited AE 
 An unsolicited AE is an AE that was not solicited using a participant diary and that is 
communicated by a participant who has signed the informed consent. Unsolicited 
AEs include serious and nonserious AEs. 
 Potential unsolicited AEs may be medically attended (i.e., symptoms or illnesses 
requiring a hospitalization, emergency room visit, or visit to/by a healthcare 
provider). The participant will be instructed to contact the site as soon as possible to 
report medically attended event(s), as well as any events that, though not medically 
attended, are of participant concern. Detailed information about reported unsolicited 
AEs will be collected by qualified site personnel and documented in the participant’s 
records. 
 Unsolicited AEs that are not medically attended nor perceived as a concern by the 
participant will be collected during an interview with the participant and by review of 
available medical records at the next visit. 
 Solicited AEs are predefined local (at the injection site) and systemic events for 
which the participant is specifically questioned, and which are noted by the 
participant in their diary. 
Events Meeting the AE Definition 
 Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (e.g., ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the Investigator (i.e., not related to progression of 
underlying disease, or more severe than expected for the participant’s condition) 
 Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition 
 New condition detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study 
 Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction 
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 Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming 
intent. Such overdoses should be reported regardless of sequelae. 
Events not Meeting the AE Definition 
 Any abnormal laboratory findings or other abnormal safety assessments that are 
associated with the underlying disease, unless judged by the Investigator to be more 
severe than expected for the participant’s condition 
 The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the participant’s 
condition 
 Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition that 
leads to the procedure is the AE 
 Situations in which an untoward medical occurrence did not occur (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. 
10.3.2. 
Definition of SAE  
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of 
the criteria listed: 
a. Results in death 
b. Is life threatening 
The term life threatening in the definition of serious refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event, 
which hypothetically might have caused death, if it were more severe. 
c. Requires inpatient hospitalization or prolongation of existing hospitalization 
 In general, hospitalization signifies that the participant has been admitted (usually 
involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the 
physician’s office or outpatient setting. Complications that occur during 
hospitalization are AEs. If a complication prolongs hospitalization or fulfills any 
other serious criteria, the event is serious. When in doubt as to whether 
hospitalization occurred or was necessary, the AE should be considered serious. 
 Hospitalization for elective treatment of a pre-existing condition that did not 
worsen from baseline is not considered an AE. 
d. Results in persistent or significant disability/incapacity 
 The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
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 This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (e.g., sprained ankle) that may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption. 
e. Is a congenital anomaly/birth defect 
f. Is a suspected transmission of any infectious agent via an authorized medicinal 
product 
g. Other situations: 
 Medical or scientific judgment should be exercised by the Investigator in deciding 
whether SAE reporting is appropriate in other situations such as important 
medical events that that may not be immediately life-threatening or result in death 
or hospitalization but may jeopardize the participant or may require medical or 
surgical intervention to prevent one of the other outcomes listed in the above 
definition. These events should usually be considered serious. 
 Examples of such events include invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias, convulsions not resulting in hospitalization, or development of 
intervention dependency or intervention abuse. All malignancies must be reported 
as SAEs. 
10.3.3. 
Recording and Follow-Up of AE and/or SAE  
AE and SAE Recording 
 When an AE/SAE occurs, it is the responsibility of the Investigator to review all 
documentation (e.g., hospital progress notes, laboratory reports, and diagnostics 
reports) related to the event. 
 The Investigator will then record all relevant AE/SAE information. 
 It is not acceptable for the Investigator to send photocopies of the participant’s 
medical records in lieu of completion of the required form. 
 There may be instances when copies of medical records for certain cases are 
requested by the Sponsor/designee. In this case, all participant identifiers, except for 
the participant number, will be redacted on the copies of the medical records before 
submission. 
 The Investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not 
the individual signs/symptoms) will be documented as the AE/SAE. 
Assessment of Intensity 
The Investigator will make an assessment of intensity based on the CTCAE grades [36] for each 
AE and SAE reported during the study. 
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Assessment of Causality 
 The Investigator is obligated to assess the relationship between study intervention and 
each occurrence of each AE/SAE. The Investigator will use clinical judgment to 
determine the relationship. 
 A reasonable possibility of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot be 
ruled out. 
 Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention 
administration, will be considered and investigated. 
 For causality assessment, the Investigator will also consult the IB and/or product 
information, for marketed products. 
 The Investigator must review and provide an assessment of causality for each 
AE/SAE and document this in the medical notes. There may be situations in which an 
SAE has occurred, and the Investigator has minimal information to include in the 
initial report. However, it is very important that the Investigator always assess 
causality for every event before the initial transmission of the SAE data. 
 The Investigator may change their opinion of causality considering follow-up 
information and send an SAE follow-up report with the updated causality assessment. 
 The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
Follow-up of AEs and SAEs 
 The Investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
Sponsor to elucidate the nature and/or causality of the AE or SAE as fully as possible. 
This may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other health care professionals. 
 If a participant dies during participation in the study or during a recognized follow-up 
period, the Investigator will provide Sponsor/designee with a copy of any postmortem 
findings including histopathology. 
 New or updated information will be recorded in the originally submitted documents. 
 The Investigator will submit any updated SAE data to Sponsor/designee within 24 
hours of receipt of the information. 
10.3.4. 
Reporting of SAEs  
SAE Reporting to Sponsor/designee via an Electronic Data Collection Tool 
 The primary mechanism for reporting an SAE to Sponsor/designee will be the 
electronic data collection tool. 
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 If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) to report the event within 24 hours. 
 The site will enter the SAE data into the electronic system as soon as it becomes 
available. 
 After the study is completed at a given site, the electronic data collection tool will be 
taken offline to prevent the entry of new data or changes to existing data. 
 If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken offline, then the site can report this information on a paper SAE form (see next 
section) or to the Sponsor/designee by telephone. 
 Contacts for SAE reporting can be found in the SOM. 
SAE Reporting to Sponsor/designee via Paper Data Collection Tool 
 Facsimile transmission of the SAE paper data collection tool is the preferred method 
to transmit this information to the Sponsor/designee. 
 In rare circumstances and in the absence of facsimile equipment, notification by 
telephone either verbally (less preferred) or by cell phone photo (more preferred) is 
acceptable with a copy of the SAE data collection tool sent by overnight mail or 
courier service. 
 Initial notification via telephone does not replace the need for the Investigator to 
complete and sign the SAE data collection tool within the designated reporting 
timeframes. 
 Contacts for SAE reporting can be found in SOM. 
 
 
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10.4. 
APPENDIX 4: Contraceptive Guidance  
In order to prevent pregnancy, female participants must satisfy one of the following criteria: 
 Be post-menopausal, defined as having had ≥12 months of natural (spontaneous) 
amenorrhea with an appropriate clinical/hormonal profile (e.g., FSH > 40 IU/L) 
 Have undergone surgical sterilization (surgical bilateral oophorectomy with or 
without hysterectomy), total hysterectomy or tubal ligation at least six weeks before 
taking study treatment. In case of oophorectomy alone, only when the reproductive 
status of the woman has been confirmed by follow up hormone level assessment. 
 All other female participants must meet both of the following criteria: 
 Two negative pregnancy tests (1 at screening and 1 at randomization) 
 Use of an intrauterine device, from at least 3 months prior to the baseline visit 
  through at least 4 months after the last dose of bimagrumab/placebo i.v. 
 Use of an additional contraceptive (barrier) method from screening through at 
least 4 months after the last dose of bimagrumab/placebo i.v. to further reduce the 
risk of unintended pregnancy. 
 
 
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10.5. 
APPENDIX 5: Genetics  
10.5.1. 
Optional Consent  
The study includes an optional DNA component which requires a separate informed consent 
signature if the participant agrees to participate. 
Genetic variation may impact a participant’s response to study intervention, susceptibility to, and 
severity and progression of disease. Variable response to study intervention may be due to 
genetic determinants that impact drug absorption, distribution, metabolism, and excretion; 
mechanism of action of the drug; disease etiology; and/or molecular subtype of the disease being 
treated. Therefore, where local regulations and IRB/IEC allow, a blood sample will be collected 
for DNA analysis from consenting participants. 
10.5.2. 
Use/Analysis of DNA  
As technology changes over time, the most appropriate technology will be used at the time the 
exploratory DNA research is performed. This may include the study of the entire genome. 
In addition, recent advances in genotyping technologies have made genome-wide approaches 
possible. Genome-wide approaches may also be undertaken within the restricted scope described 
below. 
Exploratory DNA research studies are planned as a part of this study with the objectives of 
identifying genetic factors which may 
 be related to obesity 
 predict response to treatment with bimagrumab 
 predict relative susceptibility to drug-drug interactions 
 predict genetic predisposition to side effects 
Additional analyses may be conducted if it is hypothesized that this may help further understand 
the clinical data. 
The samples may be analyzed as part of a multi-study assessment of genetic factors involved in 
the response to bimagrumab or study interventions of this class to understand the study disease 
or related conditions. 
The results of genetic analyses may be reported in the clinical study report (CSR) or in a separate 
study summary. 
10.5.3. 
Storage of Genetic Samples  
The Sponsor will store the DNA samples in a secure storage space with adequate measures to 
protect confidentiality. 
The samples will be retained while research on study interventions of this class or 
obesity/overweight continues but no longer than 10 years or other period as per local 
requirements. 
 
 
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10.6. 
APPENDIX 6: Liver Safety: Suggested Actions and Follow-up 
Assessments  
Table 7: 
Liver Event and Laboratory Trigger Definitions 
Definition 
Thresholds 
Potential Hy’s law case 
 ALT or AST >3x ULN and total bilirubin >2x ULN 
without notable increase in ALP to >2x ULN) 
If ALT, AST, and total bilirubin normal 
at baseline 
 ALT or AST >8x ULN 
 ALT or AST >5x ULN and ≤8x ULN 
 ALT or AST>3x ULN and ≤5x ULN 
 ALP >2x ULN (in the absence of known bone 
pathology) 
 Total bilirubin >3x ULN (in the absence of known 
Gilbert syndrome) 
ALT or AST elevation with 
coagulopathy 
 ALT or AST >3x ULN and PT/INR >1.5 (in the 
absence of anti-coagulation) 
ALT or AST elevation accompanied by 
symptoms 
 ALT or AST >3x ULN accompanied by (general) 
malaise, fatigue, abdominal pain, nausea, or vomiting, 
or rash, or eosinophilia 
Isolated ALP elevation 
 ALP >2x ULN (unless attributable to bone-specific 
ALP)  
Others 
 Any clinical event of jaundice 
 Any AE potentially indicative of liver toxicity 
Table 8: 
Actions Required for Liver Events and Laboratory Triggers  
Criteria 
Actions required 
Potential Hy’s law case 
ALT or AST elevation with coagulopathy 
ALT or AST elevation accompanied by 
symptoms 
Isolated ALT or AST elevation >8x ULN 
Jaundice 
 If possible Hy’s law, report to sponsor within 24 h 
 Discontinue study treatment 
 Hospitalize if clinically appropriate 
 Establish causality 
Isolated ALT or AST elevation >5x ULN 
and ≤8 x ULN 
 If confirmed, consider interruption or discontinuation 
of study drugs 
 If elevation persists for more than 2 weeks, 
discontinue study drugs 
 Follow-up for symptoms 
 Establish causality 
Isolated ALT or AST elevation >3x ULN 
and ≤5x ULN 
 Monitor liver chemistry at least 2 times weekly 
 If confirmed, consider interruption or discontinuation 
of study drugs 
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Criteria 
Actions required 
 Follow-up for symptoms 
Isolated ALP elevation 
 Repeat liver chemistry test within 48–72 hours 
 If elevation is confirmed, measure fractional ALP; if 
>50% of it is liver origin, establish hepatic causality 
Any AE potentially indicative of liver 
toxicity 
 Consider study treatment interruption or 
discontinuation 
 Hospitalize if clinically appropriate 
Table 9: 
Follow Up Requirements for Liver Laboratory Triggers - Isolated 
Hyperbilirubinemia 
Criteria 
Actions required 
Total bilirubin (isolated) 
 
>1.5–3x ULN 
 Maintain treatment 
 Repeat LFTs within 48-72 hours 
 Monitor LFTs weekly until resolution to ≤ Grade 1 or 
to baseline 
>3-10x ULN (in the absence of known 
Gilbert syndrome) 
 Interrupt treatment 
 Repeat LFT within 48-72 hours 
 Monitor LFTs weekly until resolution to ≤ Grade 1 or 
to baseline (ALT, AST, total bilirubin, Alb, PT/INR, 
ALP and GGT) 
 Test for hemolysis (e.g., reticulocytes, haptoglobin, 
unconjugated [indirect] bilirubin) 
 Hospitalize if clinically appropriate 
 Establish causality 
>10x ULN 
 Discontinue the study treatment immediately 
 Hospitalize the participant 
 Establish causality 
Any AE potentially indicative of a liver 
toxicity 
 Consider study treatment interruption or 
discontinuation 
 Hospitalization if clinically appropriate 
 Establish causality 
In all instances, record the AE and contributing factors (e.g., concomitant medications, medical 
history, laboratory results) in the appropriate eCRF. 
Based on investigator’s discretion, investigation(s) for contributing factors for the liver event can 
include serology tests, imaging, and pathology assessments, hepatologist’s consultancy, 
obtaining more detailed history of symptoms and prior or concurrent diseases, history of 
concomitant drug use, exclusion of underlying liver disease. 
 
 
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10.7. 
APPENDIX 7: Lipase and Amylase Safety  
To ensure participant safety and enhance reliability in determining the potential for pancreatic 
events with bimagrumab, a standardized process for identification, monitoring and evaluation of 
pancreatic events should be followed (Table 10). 
Table 10: 
Safety Monitoring Guidance for Amylase and Lipase Elevations 
Event 
Follow up monitoring  
Lipase and/or amylase 
>2x and ≤3x ULN 
 
If asymptomatic, re-check enzymes (amylase, lipase) and additional follow 
up at discretion of Investigator. 
 
If clinical symptoms are present (e.g., abdominal pain, nausea, diarrhea) 
and suggestive of pancreatic involvement, re-check enzymes (amylase, 
lipase) and inflammatory markers (e.g., C-reactive protein) and consider 
pancreatic imaging (e.g., contrast-enhanced CT or MRI/MRCP) to evaluate 
for presence of pancreatitis. 
 
If serum lipase is >2x ULN and >1.5x baseline at or prior to Visit 4, 
interrupt study treatments and consult with medical monitor. 
Lipase and/or amylase 
>3x and ≤5X ULN 
 
If at or prior to Visit 4, interrupt study treatments and consult with medical 
monitor. 
 
Re-check enzymes (amylase, lipase) and inflammatory markers (C-reactive 
protein) independent of presence of clinical symptoms, until enzyme levels 
return to <2x ULN. 
 
Assess participant for clinical symptoms (e.g., abdominal pain, nausea, 
diarrhea). 
 
Conduct pancreatic imaging (e.g., CECT or MRI/MRCP) to evaluate for 
presence of pancreatitis. 
 
If clinical symptoms and/or pancreatic imaging indicative of pancreatitis, 
discontinue study treatments. 
>5x ULN or 
confirmed diagnosis 
of pancreatitis 
 
Discontinue study treatments. 
 
Hospitalize if clinically appropriate. 
 
Establish causality. 
Medically significant pancreatic events which are considered as serious adverse events (SAEs) 
should follow the standard procedures for SAE reporting as described in Section 8.4. 
Every pancreatic event reported as an SAE should include a causality assessment of the event, 
considering alternative causes (e.g., gallstones, co-medication). 
An investigation of the pancreas needs to be followed up until resolution. A gastroenterology 
consult can be included at the Investigator’s discretion. All follow-up information, and the 
procedures performed, should be recorded in the appropriate eCRFs. 
An independent adjudication committee may be formed to adjudicate suspected cases of acute 
pancreatitis and other major adverse events in a blinded manner.  Any completed adjudications 
will be utilized in safety analyses. 
 
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10.8. 
APPENDIX 8: Creatine Kinase Safety  
To ensure participant safety and enhance reliability in determining the potential for 
rhabdomyolysis, a standardized process for identification, monitoring and evaluation of serum 
CK should be followed (Table 11). 
Table 11: 
Safety Monitoring Guidance for Creatine Kinase Elevations 
Event 
Follow up monitoring 
Creatine kinase (CK) 
>5x ULN and ≤10x 
ULN 
 
Inquire about recent intensive muscular exertion or injury, infection, body 
temperature changes, medications such as statins 
 
Assess participant for clinical symptoms (e.g., myalgia, weakness, dark 
urine). 
 
Re-check CK and check serum troponin I/T, creatinine, sodium, potassium, 
calcium, phosphate, and urine myoglobin 
 
If symptoms and/or lab tests indicative of rhabdomyolysis, discontinue 
study treatments. 
Creatine kinase (CK) 
>10x ULN or 
rhabdomyolysis is 
confirmed 
 
In addition to above actions: 
o Interrupt study drugs and consult with the medical monitor 
o Discontinue study if rhabdomyolysis is confirmed 
o Hospitalize if clinically appropriate. 
o Establish causality 
 
 
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