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CTRI Number  CTRI/2021/09/036105 [Registered on: 01/09/2021] Trial Registered Prospectively
Last Modified On: 21/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Participants with type 2 diabetes who have obesity or are overweight 
Scientific Title of Study   Efficacy and safety or tirzepatide once weekly in participants with type 2 diabetes who have obesity or are overweight: A randomised, double-blind, placebo-controlled trial (SURMOUNT-2) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
I8F-MC-GPHL dated 23/November/2020  Protocol Number 
NCT04657003  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Arora 
Designation  Medical Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA- 122001 India

Gurgaon
HARYANA
122001
India 
Phone  9820234897  
Fax    
Email  arora_rohit@lilly.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohit Arora 
Designation  Medical Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA- 122001 India


HARYANA
122001
India 
Phone  9820234897  
Fax    
Email  arora_rohit@lilly.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Sharan Shrivastava 
Designation  Associate Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA- 122001 India
Gurugram
Gurgaon
HARYANA
122001
India 
Phone  9810308697  
Fax    
Email  shrivastava_rajeev_sharan@lilly.com  
 
Source of Monetary or Material Support  
Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001 
 
Primary Sponsor  
Name  Eli Lilly and Company India Pvt Ltd 
Address  Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
India
Japan
Mexico
Russian Federation
Taiwan
United States of America  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Khadgawat  All India Institute of Medical Sciences (AIIMS)  Biotech Building, 3rd Floor, Room No. 303, Ansari Nagar, New Delhi-110029
New Delhi
DELHI 		 918527289001

rajeshkhadgawat@hotmail.com 
Dr Ghanshyam Goyal  ILS Hospital  DD-6, Sector-1, Saltlake City, Kolkata-700064
Kolkata
WEST BENGAL 		 919830400450

drgsgoyal@hotmail.com 
Dr L Sreenivasamurthy  Life Care Hospital and research Centre  #2748/2152, M.L.N. Enclave, 16th E Cross Road, 8th Main, D Block, Sahakar Nagar, Bangalore-560092
Bangalore
KARNATAKA 		 919448051046

drsreenivasamurthy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
ILS Hospital Ethics Committee  Approved 
Institute of Ethics Committee,All India Institute of Medical Sciences (AIIMS)  Submittted/Under Review 
Life Care Hospital Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Placebo administered SC 
Intervention  Tirzepatide  10 mg Tirzepatide 10 mg Tirzepatide administered subcutaneously (SC) 15 mg Tirzepatide 15 mg Tirzepatide administered SC  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
2. Have a BMI of ≥27 kg/m²
3. Are overweight or have obesity
4. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
5. Are at least 18 years of age and age of majority per local laws and regulations 
 
ExclusionCriteria 
Details  1. Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
2. Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
3. Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
4. Have self-reported change in body weight >5kg within 3 months prior to screening
5. Have had a history of chronic or acute pancreatitis
6. Change in body weight greater than 5 kg within 3 months prior to starting study
7. Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
8. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
9. History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
10. Any lifetime history of a suicide attempt 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Percent Change from Randomization in Body Weight

Percentage of Participants Who Achieve ≥5% Body Weight Reduction from Randomization 		 Randomization, 72 Weeks

72 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction from Randomization
2.Percentage of Participants Who Achieve ≥15% Body Weight Reduction from Baseline
3.Percentage of Participants who Achieve HbA1c less than 7%
4.Percentage of Participants Who Achieve HbA1c ≤6.5%
5.Percentage of Participants Who Achieve HbA1c less than 5.7%
 		 72 weeks 
1.Change from Randomization in Absolute Body Weight
2.Change from Randomization in Body Mass Index
3.Change from Randomization in HbA1c
4.Change from Randomization in Fasting Glucose
5.Change from Randomization in Waist Circumference
6.Change from Randomization in Total Cholesterol
7.Change from Randomization in Low Density Lipid (LDL) Cholesterol
8.Change from Randomization in High Density Lipid (HDL) Cholesterol
9.Change from Randomization in Very Low Density Lipid (VLDL) Cholesterol
10.Change from Randomization in Triglycerides
11.Change from Randomization in Free Fatty Acids
12.Change from Randomization in Systolic Blood Pressure (SBP)
13.Change from Randomization in Diastolic Blood Pressure (DBP)
14.Change from Randomization in Fasting Insulin
15.Change from Randomization in Short Form 36 Health Survey version 2 acute form Physical Functioning domain score
 		 Randomization, 72 Weeks 
16.Change from Randomization in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score  Randomization, 72 Weeks 
Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide   Baseline through Week 72 
 
Target Sample Size   Total Sample Size="900"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "938"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/09/2021 
Date of Study Completion (India) 07/04/2023 
Date of First Enrollment (Global)  29/03/2021 
Date of Study Completion (Global) 10/04/2023 
Estimated Duration of Trial   Years="1"
Months="7"
Days="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  www.vivli.org

  6. For how long will this data be available start date provided 20-08-2021 and end date provided 19-01-2022?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits). 
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