A Randomized, Phase 3, Double Blind Trial Comparing the Effect of the Addition of Tirzepatide Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Participants With Type 2 Diabetes
Phase: PHASE3
Conditions: Diabetes Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases
Sponsor: Eli Lilly and Company

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Title Page 
Confidential Information 
The information contained in this document is confidential and is intended for the use of clinical investigators. It is the property of 
Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical 
investigation of tirzepatide (LY3298176), unless such persons are bound by a confidentiality agreement with Eli Lilly and Company 
or its subsidiaries.  
Note to Regulatory Authorities: This document may contain protected personal data and/or commercially confidential information 
exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. 
In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or 
otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries. 
Protocol Title:
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Protocol Number: I8F-MC-GPIM
Amendment Number: E
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Brief Title: 
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Sponsor Name: (OL/LOO\DQG&RPSDQ\ 
Legal Registered Address: ,QGLDQDSROLV,QGLDQD86$ 
Regulatory Agency Identifier Number(s): 1$ 
Approval Date: 3URWRFRO$PHQGPHQWE(OHFWURQLFDOO\6LJQHGDQG$SSURYHGE\/LOO\RQGDWH
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Medical Monitor Name and Contact Information will be provided separately. 
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Table of Contents  
Title Page ........................................................................................................................................1 
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Table of Contents ...........................................................................................................................6 
1. 
Protocol Summary ........................................................................................................10 
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Introduction ...................................................................................................................22 
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Protocol Summary  
1.1. 
Synopsis  
Protocol Title:  
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Brief Title:
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Regulatory Agency Identifier Number(s):1$
Rationale:  
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Overall Design 
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Brief Summary:
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Study Population: 
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Number of Participants: 
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Intervention Groups and Duration:  
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Ethical Considerations of Benefit/Risk: 
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Data Monitoring Committee: 1R 
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2. 
Introduction  
2.1. 
Study Rationale  
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2.2. 
Background  
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2.3. 
Benefit/Risk Assessment  
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2.3.1. 
Risk Assessment  
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2.3.2. 
Benefit Assessment  
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2.3.3. 
Overall Benefit Risk Conclusion  
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4. 
Study Design  
4.1. 
Overall Design  
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4.1.1. 
Overview of Study Periods  
Study Period I (Screening and Lead-in) 
Screening (Visit 1) 
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Lead-in (Visit 2 to Visit 3) 
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Study Period II (40-Week Treatment Period) 
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Randomization (Visit 3) 
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5.1. 
Inclusion Criteria  
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LQYHVWLJDWLQJWLU]HSDWLGH
Other Exclusions 
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5.3. 
Lifestyle Considerations  
3HUWKH6R$6HFWLRQTXDOLILHGPHGLFDOSHUVRQQHOZLOOSURYLGHGLDEHWHVPDQDJHPHQW
FRXQVHOLQJZKLFKZLOOLQFOXGHLQVWUXFWLRQVRQGLHWDQGH[HUFLVHDQGHGXFDWLRQDERXWWKHVLJQV
V\PSWRPVDQGWUHDWPHQWRIK\SRJO\FHPLDVKRXOGLWRFFXU
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FRXQVHOLQJPD\EHUHYLHZHGWKURXJKRXWWKHVWXG\DVQHHGHG3HULQFOXVLRQFULWHULRQ>@
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5.4. 
Screen Failures  
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VXEVHTXHQWO\UDQGRPO\DVVLJQHGWRVWXG\GUXJ$PLQLPDOVHWRIVFUHHQIDLOXUHLQIRUPDWLRQLV
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IURPUHJXODWRU\DXWKRULWLHV0LQLPDOLQIRUPDWLRQLQFOXGHVGHPRJUDSK\VFUHHQIDLOXUHGHWDLOV
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EHUHVFUHHQHG
5.5. 
Criteria for Temporarily Delaying 
Enrollment/Randomization/Administration of Study Intervention of a 
Participant  
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6. 
Study Intervention(s) and Concomitant Therapy  
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DGPLQLVWHUHGWRDVWXG\SDUWLFLSDQWDFFRUGLQJWRWKHVWXG\SURWRFRO
6.1. 
Study Intervention(s) Administered  
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UDQGRPL]DWLRQDOOSDUWLFLSDQWVZLOOUHFHLYHVWXG\GUXJDFFRUGLQJWRWKHUDQGRPL]HGWUHDWPHQW
JURXSIRUWKHGXUDWLRQRIWKHZHHNWUHDWPHQWSHULRG)ROORZLQJUDQGRPL]DWLRQWKH
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7KLVWDEOHOLVWVWKHLQWHUYHQWLRQVXVHGLQWKLVFOLQLFDOVWXG\
Group Name
Tirzepatide 5 mg 
Tirzepatide 10 mg 
Tirzepatide 15 mg 
Placebo 
Concomitant background 
insulin for all treatment 
arms 
Intervention 
Name 
7LU]HSDWLGHPJ
7LU]HSDWLGHPJ
7LU]HSDWLGHPJ
3ODFHER
,QVXOLQ*ODUJLQH8
Dosage Level(s) 
PJ4:
PJ4:
PJ4:
1$
7LWUDWHG
Route of 
Administration 
6&
Frequency of 
Administration 
4:
4'
Use 
([SHULPHQWDOLQWHUYHQWLRQ
FRPSDUDWRU
&RQFRPLWDQWEDFNJURXQG
LQVXOLQ
Sourcing 
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Packaging and 
Labeling 
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WREHGLVSHQVHG&OLQLFDOVWXG\PDWHULDOVZLOOEHODEHOHGDFFRUGLQJWRFRXQWU\
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6.1.1. 
Tirzepatide Dosing  
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4:IRUWKHGXUDWLRQRIWKHVWXG\LQWKHPJJURXS
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Figure GPIM.1. 
Tirzepatide Dose Escalation  
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6.1.2. 
Placebo Dosing  
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6.1.3. 
Insulin Glargine Dosing  
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Table GPIM.1. 
Treat-to-Target Algorithm  
Median Fasting Blood Glucosea 
Adjustment of Insulin Glargine Dose 
mg/dL 
mmol/L 
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6.1.4. 
Medical Devices  
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6.2. 
Preparation, Handling, Storage, and Accountability  
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6.3. 
Measures to Minimize Bias: Randomization and Blinding  
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6.4. 
Study Intervention Compliance  
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6.5. 
Dose Modification  
6.5.1. 
Tirzeptide  
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6.5.1.1. 
Management of Participants with Gastrointestinal Symptoms  
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6.5.2. 
Background Antihyperglycemic Medications  
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6.6. 
Continued Access to Study Intervention after the End of the Study  
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6.7. 
Treatment of Overdose  
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6.8. 
Concomitant Therapy  
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7. 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal  
7.1. 
Discontinuation of Study Intervention  
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7.1.1. 
Permanent Discontinuation from Study Intervention  
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Participant Decision 
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7.1.2. 
Temporary Interruption of Study Intervention  
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7.2. 
Participant Discontinuation/Withdrawal from the Study  
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7.2.1. 
Discontinuation of Inadvertently Enrolled Participants  
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7.3. 
Lost to Follow up  
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8. 
Study Assessments and Procedures  
 
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8.1. 
Efficacy Assessments  
8.1.1. 
Primary Efficacy Assessments  
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8.1.2. 
Secondary Efficacy Assessments  
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8.1.3. 
Tertiary Assessments and Procedures  
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8.1.4. 
Appropriateness of Assessments  
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8.2. 
Safety Assessments  
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8.2.1. 
Physical Examinations  
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Vital Signs  
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8.2.3. 
Electrocardiograms  
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Clinical Safety Laboratory Tests  
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8.2.5. 
Safety Monitoring  
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8.3.2. 
Serious Adverse Events  
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8.3.2.1. 
Suspected Unexpected Serious Adverse Reactions  
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8.3.3. 
Pregnancy  
Collection of pregnancy information 
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8.3.4. 
Adverse Events of Special Interest  
8.3.4.1. 
Hypoglycemia  
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EHWUDLQHGDERXWVLJQVDQGV\PSWRPVRIK\SRJO\FHPLDKRZWRWUHDWK\SRJO\FHPLDDQGKRZWR
FROOHFWDSSURSULDWHLQIRUPDWLRQIRUHDFKHSLVRGHRIK\SRJO\FHPLDLQWKHVWXG\DFFRUGLQJWRWKH
6R$6HFWLRQ6LWHSHUVRQQHOZLOOHQWHUWKLVLQIRUPDWLRQLQWRWKHH&5)DWHDFKYLVLW
,QYHVWLJDWRUVVKRXOGXVHWKHIROORZLQJFODVVLILFDWLRQRIK\SRJO\FHPLD$'$F
Level 1 hypoglycemia: 
Glucose <3.9 mmol/L (<70 mg/dL) and % (%	):/HYHOK\SRJO\FHPLD
FDQDOHUWDSHUVRQWRWDNHDFWLRQVXFKDVWUHDWPHQWZLWKIDVWDFWLQJFDUERK\GUDWHV3URYLGHUV
VKRXOGFRQWLQXHWRFRXQVHOSDUWLFLSDQWVWRWUHDWK\SRJO\FHPLDDWWKLVJOXFRVHDOHUWYDOXH
Level 2 hypoglycemia:  
Glucose <3.0 mmol/L (<54 mg/dL):/HYHOK\SRJO\FHPLDLV DOVRUHIHUUHGWRDV
GRFXPHQWHGRUEORRGJOXFRVHFRQILUPHGK\SRJO\FHPLDZLWKJOXFRVHPPRO/
PJG/7KLVJOXFRVHWKUHVKROGLVFOLQLFDOO\UHOHYDQWUHJDUGOHVVRIWKHSUHVHQFHRU
DEVHQFHRIV\PSWRPVRIK\SRJO\FHPLD
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Level 3 hypoglycemia:  
Severe hypoglycemia (in adults):  $VHYHUHHYHQWFKDUDFWHUL]HGE\DOWHUHGPHQWDODQGRU
SK\VLFDOVWDWXVUHTXLULQJDVVLVWDQFHIRUWUHDWPHQWRIK\SRJO\FHPLD)RUH[DPSOH
SDUWLFLSDQWVKDGDOWHUHGPHQWDOVWDWXVDQGFRXOGQRWDVVLVWLQWKHLURZQFDUHRUZHUH
VHPLFRQVFLRXVRUXQFRQVFLRXVRUH[SHULHQFHGFRPDZLWKRUZLWKRXWVHL]XUHVDQGWKH
DVVLVWDQFHRIDQRWKHUSHUVRQZDVQHHGHGWRDFWLYHO\DGPLQLVWHUFDUERK\GUDWHJOXFDJRQRU
RWKHUUHVXVFLWDWLYHDFWLRQV*OXFRVHPHDVXUHPHQWVPD\QRWEHDYDLODEOHGXULQJVXFKDQ
HYHQWEXWQHXURORJLFDOUHFRYHU\DWWULEXWDEOHWRWKHUHVWRUDWLRQRIJOXFRVHFRQFHQWUDWLRQWR
QRUPDOLVFRQVLGHUHGVXIILFLHQWHYLGHQFHWKDWWKHHYHQWZDVLQGXFHGE\DORZJOXFRVH
FRQFHQWUDWLRQ
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GHILQHGDERYHLVPDGHE\WKHLQYHVWLJDWRUEDVHGRQWKHPHGLFDOQHHGRIWKH
SDUWLFLSDQWWRKDYHUHTXLUHGDVVLVWDQFHDQGLVQRWSUHGLFDWHGRQWKHUHSRUWRID
SDUWLFLSDQWVLPSO\KDYLQJUHFHLYHGDVVLVWDQFH
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PXVWUHFRUGWKHHYHQWDVVHULRXVRQWKH$(&5)DQGUHSRUWLWWR/LOO\DVDQ6$(
Nocturnal hypoglycemia:  
1RFWXUQDOK\SRJO\FHPLDLV DK\SRJO\FHPLDHYHQWLQFOXGLQJVHYHUHK\SRJO\FHPLDWKDW
occurs at nightDQGSUHVXPDEO\GXULQJVOHHS
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SHULRGPD\EHFRQVLGHUHGWREHDVLQJOHK\SRJO\FHPLFHYHQW:HLQEHUJHWDO'DQQHHWDO
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8.3.4.2. 
Severe, Persistent Hyperglycemia  
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LPEDODQFHLQJO\FHPLFFRQWURO
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VKRXOGEHFRQVLGHUHGLQSDUWLFLSDQWVZKRGHYHORSVHYHUHSHUVLVWHQWK\SHUJO\FHPLDDIWHU
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Rescue therapy option
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WKDQPD[LPXPDSSURYHGGRVHSHUFRXQWU\VSHFLILFODEHODQGLVZHOOWROHUDWHG
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8.3.4.3. 
Pancreatitis  
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8.3.4.4. 
Thyroid Malignancies and C-Cell Hyperplasia  
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8.3.4.5. 
Major Adverse Cardiovascular Event  
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8.3.4.6. 
Arrythmias and Cardiac Conduction Disorders  
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8.3.4.7. 
Hypersensitivity Events  
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8.3.4.8. 
Injection Site Reactions  
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8.3.4.9. 
Diabetic Retinopathy Complications  
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8.3.4.10. Hepatobiliary Disorders  
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8.3.4.11. Severe Gastrointestinal Adverse Events  
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8.3.4.12. Acute Renal Events  
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8.3.4.13. Metabolic Acidosis, Including Diabetic Ketoacidosis  
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8.3.4.14. Amputation/Peripheral Revascularization  
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8.3.4.15. Major Depressive Disorder/Suicidal Ideation  
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8.3.5. 
Complaint Handling  
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8.4. 
Pharmacokinetics  
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8.5. 
Pharmacodynamics  
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8.6. 
Genetics  
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8.7. 
Biomarkers  
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8.8. 
Immunogenicity Assessments  
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8.9. 
Health Economics  
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8.9.1. 
Ability to Perform Physical Activities of Daily Living  
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8.9.2. 
Impact of Weight on Self--Perception Questionnaire  
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8.9.3. 
Diabetes Treatment Satisfaction Questionnaire  
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8.9.4. 
EQ-5D-5L  
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9. 
Statistical Considerations  
9.1. 
Statistical Hypotheses  
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WKHIROORZLQJ
 
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9.1.1. 
Multiplicity Adjustment  
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9.2. 
Analyses Sets  
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Population/Analysis Set 
Description 
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9.3. 
Statistical Analyses  
9.3.1. 
General Considerations  
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6$3
9.3.2. 
Treatment Group Comparability  
9.3.2.1. 
Participant Disposition  
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9.3.2.2. 
Participant Characteristics  
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9.3.2.3. 
Concomitant Therapy  
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9.3.2.4. 
Treatment Compliance  
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9.3.3. 
Primary Endpoint(s)/Estimand(s) Analysis  
7KHSULPDU\HIILFDF\PHDVXUHLVPHDQ+E$FFKDQJHIURPEDVHOLQHDWZHHNVDQGWKH
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7KHSULPDU\HIILFDF\DVVHVVPHQWJXLGHGE\WKH³HIILFDF\´HVWLPDQGZLOOXVHWKH($67KH
DQDO\VLVPRGHOIRUFKDQJHIURPEDVHOLQHLQ+E$FDVVHVVHGRYHUWLPHXSWRWKHZHHNYLVLW
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9.3.4. 
Secondary Endpoint(s)/Estimand(s) Analysis  
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EDVHOLQHWRWKHZHHNYLVLW
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IURPEDVHOLQHWRWKHZHHNYLVLW
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ZLWK+E$FPPROPRODWWKHZHHNYLVLW
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EDVHOLQHWRWKHZHHNYLVLW
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9.3.5. 
Tertiary Endpoint(s) Analysis  
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PLVVLQJGDWDDQGZLOOEHFRQGXFWHGXVLQJWKH($6'HWDLOVZLOOEHSURYLGHGLQWKH6$3
9.3.6. 
Safety Analyses  
8QOHVVVSHFLILHGRWKHUZLVHVDIHW\DVVHVVPHQWVZLOOEHJXLGHGE\DQHVWLPDQGFRPSDULQJVDIHW\
RIWLU]HSDWLGHGRVHVZLWKSODFHERLUUHVSHFWLYHRIDGKHUHQFHWRVWXG\GUXJRULQLWLDWLRQRIUHVFXH
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FRQGXFWHGH[FOXGLQJGDWDDIWHUWKHLQWURGXFWLRQRIDQRWKHUDQWLK\SHUJO\FHPLFWKHUDS\
$(VZLOOEHFRGHGIURPWKHDFWXDOWHUPXVLQJWKH0HGLFDO'LFWLRQDU\IRU5HJXODWRU\$FWLYLWLHV
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9.3.6.1. 
Hypoglycemic Events  
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FDWHJRU\HLWKHUWRWDORUQRFWXUQDOZLOOEHFRPSDUHGEHWZHHQWLU]HSDWLGHGRVHVDQGSODFHERXVLQJ
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GDWDDIWHULQWURGXFWLRQRIDQRWKHUDQWLK\SHUJO\FHPLFWKHUDS\IRUH[DPSOHUHVFXHWKHUDS\
9.3.6.2. 
Gastrointestinal Events  
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SURYLGHGE\HDFKWUHDWPHQW
9.3.6.3. 
Adjudicated Cardiovascular Events  
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FRQILUPHGE\DQLQGHSHQGHQW&(&ZLOOEHSURYLGHG7KHGDWHVRIUDQGRPL]DWLRQHYHQWILUVW
GRVHDQGODVWGRVHRIVWXG\GUXJDQGWLPHIURPUDQGRPL]DWLRQWRWKHHYHQWZLOOEHOLVWHG
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9.3.6.4. 
Central Laboratory Measures, Vital Signs, and Electrocardiograms  
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PRGHOWRPDNHFRPSDULVRQVDPRQJWUHDWPHQWJURXSVUHODWLYHWRFRQWLQXRXVFKDQJHIURP
EDVHOLQHYDOXHVDVVHVVHGRYHUWLPHZLOOEHDQ0050VLPLODUWRWKHSULPDU\HIILFDF\DQDO\VLV
DQGZLWKEDVHOLQHPHDVXUHPHQWDVDFRYDULDWH$QXQVWUXFWXUHGFRYDULDQFHVWUXFWXUHZLOOPRGHO
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7KHSHUFHQWDJHVRISDUWLFLSDQWVZLWK7(DEQRUPDOKLJKRUORZODERUDWRU\PHDVXUHVDWDQ\WLPH
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DEQRUPDOYDOXHLVGHILQHGDVDFKDQJHIURPQRUPDOYDOXHDWEDVHOLQHWRDYDOXHJUHDWHUWKDQWKH
KLJKOLPLWDWDQ\WLPHGXULQJ3HULRGV,,DQG,,,$7(ORZUHVXOWLVGHILQHGDVDFKDQJHIURPD
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ODERUDWRU\UHIHUHQFHUDQJHV
9.3.7. 
Other Analyses  
9.3.7.1. 
Health Economics  
$QDO\VHVRIDFWXDODQGFKDQJHIURPEDVHOLQHLQSDWLHQWUHSRUWHGRXWFRPH352VFRUHVZLOOEH
FRQGXFWHGXVLQJOLQHDUPRGHOVZLWKEDVHOLQH352VFRUHVWUHDWPHQWDQGRWKHUIDFWRUVWKDWPD\EH
FRQVLGHUHGUHOHYDQW7KHVHYDULDEOHVZLOOEHVSHFLILHGLQWKH6$3
9.3.7.2. 
Subgroup Analyses  
6XEJURXSDQDO\VHVRIPHDQFKDQJHLQ+E$FIURPEDVHOLQHWRWKHZHHNYLVLWZLOOEHSURYLGHG
E\DJHJHQGHUGXUDWLRQRIGLDEHWHVEDVHOLQH+E$FRU!>ޓPPROPRO@
DQGEDVHOLQH6*/7LXVH<HVRU1R
9.4. 
Interim Analysis  
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QHFHVVDU\IRUUHDVRQVRWKHUWKDQDVDIHW\FRQFHUQWKHSURWRFROPXVWEHDPHQGHG
8QEOLQGLQJGHWDLOVDUHVSHFLILHGLQWKHXQEOLQGLQJSODQVHFWLRQRIWKH6$3RULQDVHSDUDWH
XQEOLQGLQJSODQGRFXPHQW
9.5. 
Sample Size Determination  
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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  
 
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10.1.2. 
Financial Disclosure  
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10.1.3. 
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10.1.4. 
Data Protection  
 
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10.1.5. 
Committees Structure  
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10.1.6. 
Dissemination of Clinical Study Data  
Reports
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10.1.7. 
Data Quality Assurance  
 
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10.1.8. 
Source Documents  
 
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10.1.9. 
Study and Site Start and Closure  
First Act of Recruitment 
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10.1.10. 
Publication Policy  
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10.1.11. 
Investigator Information  
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10.5.
Appendix 5: Liver Safety: Suggested Actions and Follow-up 
Assessments
10.5.1.
Hepatic Safety Monitoring
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10.5.2.
Hepatic Monitoring Tests
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10.6. 
Appendix 6: World Health Organization Classification of Diabetes 
and Diagnostic Criteria  
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Appendix 7: Protocol GPIM Standardized Protocols for the 
Measurement of Height, Weight and Waist Circumference  
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10.8. 
Appendix 8: Provisions for Changes in Study Conduct During 
Exceptional Circumstances  
Implementation of this appendix 
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LQYHVWLJDWRU
Exceptional circumstances 
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([DPSOHVLQFOXGHSDQGHPLFVRUQDWXUDOGLVDVWHUV7KHVHGLVUXSWLRQVPD\OLPLWWKHDELOLW\RIWKH
LQYHVWLJDWRUVSDUWLFLSDQWVRUERWKWRDWWHQGRQVLWHYLVLWVRUWRFRQGXFWSODQQHGVWXG\SURFHGXUHV
Implementing changes under exceptional circumstances 
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LPSOHPHQWFKDQJHVLISHUPLWWHGE\ORFDOUHJXODWLRQV
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DSSURYDOVDQGQRWLILFDWLRQVPXVWEHUHWDLQHGLQWKHVWXG\UHFRUGV 
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Considerations for making a change 
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3UDFWLFHHQDEOLQJSDUWLFLSDQWVWRFRQWLQXHVDIHO\LQWKHVWXG\DQGPDLQWDLQLQJWKHLQWHJULW\RIWKH
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Informed consent 
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Changes in study conduct during exceptional circumstances 
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UHJXODWLRQVDUHQRWDOORZHG
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Remote visits 
Types of remote visits 
Telemedicine:  
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DVVHVVPHQWV$VVHVVPHQWVWREHFRPSOHWHGLQWKLVPDQQHULQFOXGHEXWDUHQRWOLPLWHGWR
PHGLFDOKLVWRU\$(VDQGSURGXFWFRPSODLQWVFRQFRPLWDQWPHGLFDWLRQVGLDEHWHVHGXFDWLRQ
UHPLQGLQJSRLQW60%*UHYLHZLQJLQVXOLQGRVHDQGDGMXVWPHQWSHU777DOJRULWKPDVVHVVLQJ
FRPSOLDQFHZLWKLQVXOLQGRVHDGMXVWPHQW777DOJRULWKPUHYLHZLQJGLDU\
Other alternative locations:
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DSSURYDORIVSRQVRU
Data capture 
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H[SODQDWLRQIRUDQ\GDWDPLVVLQJEHFDXVHRIPLVVHGLQSHUVRQVLWHYLVLWV
Safety reporting 
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UHSRUWLQJRIDGYHUVHHYHQWV$(VVHULRXVDGYHUVHHYHQWV6$(VDQGSURGXFWFRPSODLQWV
UHPDLQXQFKDQJHG
Return to on-site visits 
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UHDVRQDEO\SRVVLEOHZKLOHHQVXULQJWKHVDIHW\RIERWKWKHSDUWLFLSDQWVDQGWKHVLWHSHUVRQQHO
Local laboratory testing option 
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ODERUDWRU\WHVWLQJPXVWEHUHWDLQHGIRU+E$FDQG)6*DW9LVLWDQG9LVLW7KHORFDO
ODERUDWRU\PXVWEHTXDOLILHGLQDFFRUGDQFHZLWKDSSOLFDEOHORFDOUHJXODWLRQV&OLQLFDOO\
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LQYHVWLJDWRU 
Study intervention and ancillary supplies (including participant diaries) 
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Screening period guidance  
7RHQVXUHVDIHW\RIVWXG\SDUWLFLSDQWVODERUDWRU\YDOXHVDQGRWKHUHOLJLELOLW\DVVHVVPHQWVWDNHQ
DW9DUHYDOLGIRUDPD[LPXPRIGD\V7KHIROORZLQJUXOHVZLOOEHDSSOLHGIRUDFWLYH
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Adjustments to visit windows  
:KHQHYHUSRVVLEOHDQGVDIHWRGRVRDVGHWHUPLQHGE\WKHLQYHVWLJDWRU¶VGLVFUHWLRQSDUWLFLSDQWV
VKRXOGFRPSOHWHWKHXVXDO6FKHGXOHRI$FWLYLWLHV7RPD[LPL]HWKHSRVVLELOLW\WKDWWKHVHYLVLWV
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IURPWKHVSRQVRU7KLVPLQLPL]HVPLVVLQJGDWDDQGSUHVHUYHVWKHLQWHQGHGFRQGXFWRIWKHVWXG\
7KLVWDEOHGHVFULEHVWKHDOORZHGDGMXVWPHQWVWRYLVLWZLQGRZV
Visit Number 
Tolerance 
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1RFKDQJH
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EHSURYLGHGWRDYRLGLQWHUUXSWLRQDQGPDLQWDLQRYHUDOOLQWHJULW\RIWKHVWXG\
Documentation 
Changes to study conduct will be documented 
6LWHVZLOOLGHQWLI\DQGGRFXPHQWWKHGHWDLOVRIKRZSDUWLFLSDQWVYLVLWVW\SHVDQGFRQGXFWHG
DFWLYLWLHVZHUHDIIHFWHGE\H[FHSWLRQDOFLUFXPVWDQFHV'LVSHQVLQJVKLSPHQWUHFRUGVRIVWXG\
LQWHUYHQWLRQDQGUHOHYDQWFRPPXQLFDWLRQVLQFOXGLQJGHOHJDWLRQVKRXOGEHILOHGZLWKVLWHVWXG\
UHFRUGV
Source documents at alternate locations 
6RXUFHGRFXPHQWVJHQHUDWHGDWDORFDWLRQRWKHUWKDQWKHVWXG\VLWHVKRXOGEHSDUWRIWKH
LQYHVWLJDWRU¶VVRXUFHGRFXPHQWDWLRQDQGVKRXOGEHWUDQVIHUUHGWRWKHVLWHLQDVHFXUHDQGWLPHO\
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10.9. 
Appendix 9: Abbreviations and Definitions  
Term 
Definition 
AE 
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LQYHVWLJDWLRQVXEMHFWDGPLQLVWHUHGDSKDUPDFHXWLFDOSURGXFWWKDWGRHVQRWQHFHVVDULO\
KDYHDFDXVDOUHODWLRQVKLSZLWKWKLVWUHDWPHQW$QDGYHUVHHYHQWFDQWKHUHIRUHEHDQ\
XQIDYRUDEOHDQGXQLQWHQGHGVLJQLQFOXGLQJDQDEQRUPDOODERUDWRU\ILQGLQJV\PSWRP
RUGLVHDVHWHPSRUDOO\DVVRFLDWHGZLWKWKHXVHRIDPHGLFLQDOLQYHVWLJDWLRQDOSURGXFW
ZKHWKHURUQRWUHODWHGWRWKHPHGLFLQDOLQYHVWLJDWLRQDOSURGXFW
ALP 
DONDOLQHSKRVSKDWDVH
ALT 
DODQLQHDPLQRWUDQVIHUDVH
ANCOVA 
DQDO\VLVRIFRYDULDQFH
APPADL 
$ELOLW\WR3HUIRUP3K\VLFDO$FWLYLWLHVRI'DLO\/LYLQJ
AST 
DVSDUWDWHDPLQRWUDQVIHUDVH
BG 
%ORRGJOXFRVH
blinding/masking 
$GRXEOHEOLQGVWXG\LVRQHLQZKLFKQHLWKHUWKHSDUWLFLSDQWVXEMHFWQRUDQ\RIWKH
LQYHVWLJDWRURUVSRQVRUSHUVRQQHOZKRDUHLQYROYHGLQWKHWUHDWPHQWRUFOLQLFDO
HYDOXDWLRQRIWKHSDUWLFLSDQWVDUHDZDUHRIWKHWUHDWPHQWUHFHLYHG
BMI 
ERG\PDVVLQGH[
CEC 
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CHF 
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CI 
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CIOMS 
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CKD-EPI 
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CMO 
&KLHI0HGLFDO2IILFHU
CMV 
F\WRPHJDORYLUXV
COA 
FOLQLFDORXWFRPHDVVHVVPHQW
complaint 
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UHODWHGWRWKHLGHQWLW\TXDOLW\SXULW\GXUDELOLW\UHOLDELOLW\VDIHW\RUHIIHFWLYHQHVVRU
SHUIRUPDQFHRIDGUXJRUGUXJGHOLYHU\V\VWHP
compliance 
$GKHUHQFHWRDOOVWXG\UHODWHGJRRGFOLQLFDOSUDFWLFH*&3DQGDSSOLFDEOHUHJXODWRU\
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CONSORT 
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COVID-19 
&RURQDYLUXV'LVHDVH
CRF 
FDVHUHSRUWIRUP
CRP 
FOLQLFDOUHVHDUFKSK\VLFLDQ,QGLYLGXDOUHVSRQVLEOHIRUWKHPHGLFDOFRQGXFWRIWKHVWXG\
5HVSRQVLELOLWLHVRIWKH&53PD\EHSHUIRUPHGE\DSK\VLFLDQFOLQLFDOUHVHDUFK
VFLHQWLVWJOREDOVDIHW\SK\VLFLDQRURWKHUPHGLFDORIILFHU
CSR 
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CT 
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CTA 
&OLQLFDO7ULDO$JUHHPHQW
CV 
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DPP-4 
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DTSQs 
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EAS 
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EBV 
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eCRF 
HOHFWURQLFFDVHUHSRUWIRUP
EDC 
HOHFWURQLFGDWDFDSWXUHV\VWHP
enroll 
7KHDFWRIDVVLJQLQJDSDUWLFLSDQWWRDWUHDWPHQW3DUWLFLSDQWVZKRDUHHQUROOHGLQWKH
VWXG\DUHWKRVHZKRKDYHEHHQDVVLJQHGWRDWUHDWPHQW
EQ-5D-5L 
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ERB 
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ET 
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FAS 
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FBG 
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FSG 
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FSH 
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GCP 
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GIP 
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GLP-1 
JOXFDJRQOLNHSHSWLGH
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HDV 
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HbA1c 
KHPRJORELQ$F
IB 
,QYHVWLJDWRU¶V%URFKXUH
ICF 
LQIRUPHGFRQVHQWIRUP
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Signature Page for VV-CLIN-135512 v1.0
Signature Page for VV-CLIN-135512 v1.0
Approval
Statistician
16-Nov-2023 13:25:08 GMT+0000
Approval
Medical Director
17-Nov-2023 21:22:56 GMT+0000
Approved on 17 Nov 2023 GMT
PPD
PPD