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CTRI Number  CTRI/2020/04/024660 [Registered on: 16/04/2020] Trial Registered Prospectively
Last Modified On: 22/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Participants without Type 2 Diabetes who are Overweight. 
Scientific Title of Study   Efficacy and Safety of Tirzepatide Once Weekly in Participants without Type 2 Diabetes Who Have Obesity or are Overweight with Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
(SURMOUNT-1) Protocol I8F- MC-GPHK version dated 09/Sep/2019  DCGI 
NCT04184622  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  Eli Lilly and Company (India) Pvt. Ltd. Plot No - 92, Sec - 32, Institutional Area, Gurgaon - 122001, Haryana, India

Gurgaon
HARYANA
122001
India 
Phone    
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  Eli Lilly and Company (India) Pvt. Ltd. Plot No - 92, Sec - 32, Institutional Area, Gurgaon - 122001, Haryana, India


HARYANA
122001
India 
Phone    
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  Eli Lilly and Company (India) Pvt. Ltd. Plot No - 92, Sec - 32, Institutional Area, Gurgaon - 122001, Haryana, India

Gurgaon
HARYANA
122001
India 
Phone    
Fax    
Email  shrivastava_rajeev_sharan@lilly.com  
 
Source of Monetary or Material Support  
Eli Lilly and Company (India) Pvt. Ltd,Plot No – 92, Sec – 32, Institutional Area, Gurgaon – 122001  
 
Primary Sponsor  
Name  Eli Lilly and Company India Pvt Ltd  
Address  Plot No – 92, Sec – 32, Institutional Area, Gurgaon – 122001 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
China
India
Japan
Mexico
Russian Federation
Taiwan
United States of America  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Naval Kishore Vikram  All India Institute of Medical Sciences (AIIMS)  Ansari Nagar, New Delhi-110029 India
New Delhi
DELHI 		 9810007331

navalvikram@gmail.com 
Dr Harish Kumar  AMRITA Institute of Medical Sciences and Research Centre  AIMS Ponekkara Post, Kochi, Kerala 682041 India
Kollam
KERALA 		 04842801234

harishkumar@aims.amrita.edu 
Dr Bipin Kumar Sethi  Care Hospitals  2-260 /A-E Babu Khan Chambers, Road No 10 Banjara Hills, Hyderabad, Andhra Pradesh-500035 India
Hyderabad
TELANGANA 		 9440365585

sethibipin54@gmail.com 
Dr Sandeep Julka  CHL-Hospitals [Unit of Convenient Hospitals Ltd]  Clinical Research Department, 4th floor, Next to Super Deluxe Room - 423 (Behind Physiotherapy Department), CHL-Hospitals, Near L.I.G. Square, Agra Bombay Road, Indore - 452008, Madhya Pradesh, India.
Indore
MADHYA PRADESH 		 7314774236

sandeep_julka@yahoo.com 
Dr Vaishali Chetan Deshmukh  Deenanath Mangeshkar Hospital & Research Center  Near Mhatre Bridge, Erandwane, Pune, Maharashtra-411004, India.
Pune
MAHARASHTRA 		 912040151000

drvaishaliresearch@gmail.com 
Dr Ajay Aggarwal  Fortis Hospital  A Block Shalimar Bagh, Delhi- 110088, India
New Delhi
DELHI 		 01145302222

endocrinologist39@yahoo.co.in 
Dr Hemant Ramsharan Gupta  Grant Government Medical College & Sir J. J. Group of Hospitals  J J Marg, Nagpada-Mumbai Central, Off Jijabhoy Road, Byculla, Mumbai, Maharashtra 400008 India
Mumbai
MAHARASHTRA 		 02223735555

drhemantgupta@hotmail.com 
Dr Parag Rajnikant Shah  Gujarat Endocrine Centre  B-201, Silver Brook, Opp. Doctor House, Nr. Parimal Crossing, Ellis bridge, Ahmedabad, Gujarat 380009 India
Ahmadabad
GUJARAT 		 7926461316

paragendo@gmail.com 
Dr Ghanshyam Goyal  ILS Hospitals  Salt Lake DD-6 Sector-1 Salt Lake City, Kolkata, West Bengal-700064, India
Kolkata
WEST BENGAL 		 03340206500

drgsgoyal@hotmail.com 
Dr Jugal Velji Gada  Topiwala National Medical College & BYL Nair Hospital  Dept. of Endocrinology 19, 4th floor, College Building, Dr. A. L. Nair Road, Mumbai, Maharashtra 400008 India
Mumbai
MAHARASHTRA 		 02223027182

jugal.gada@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Gastroplus Ethics Committee, Gastroplus Hospital  Approved 
ILS Hospitals Ethics Committee  Approved 
Institute Ethics Committee  Approved 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee, AMRITA Institute of Medical Sciences and Research Centre  Submittted/Under Review 
Institutional Ethics Committee, Care Hospital  Approved 
Institutional Ethics Committee, Fortis Hospital  Approved 
Institutional Ethics Committee, Grant Government Medical College and Sir JJ Group of Hospitals  Submittted/Under Review 
Institutional Ethics Committee, Lata Mangeshkar Medical Foundation’s, Deenanath Mangeshkar Hospital & Research Center  Approved 
Integrity Ethics committee, Convenient Hospitals Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E136||Other specified diabetes mellituswith other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Placebo administered SC once a week. 
Intervention  Tirzepatide  5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
History of at least one unsuccessful dietary effort to lose body weight 
 
ExclusionCriteria 
Details  Diabetes mellitus
Change in body weight greater than 5 kg within 3 months prior to starting study
Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
History of pancreatitis
Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
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 Baseline in Body Weight
Percentage of Participants who Achieve ≥5% Body Weight Reduction 		 Baseline, Week 72
Week 72 
 
Secondary Outcome  
Outcome  TimePoints 
Change from Baseline in Body Weight  Baseline, Week 20  
Percent Change from Baseline in Body Weight   Baseline, Week 176 
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Percentage of Participants who Achieve ≥15% Body Weight Reduction  		 Week 72 
Percentage of Participants who Achieve ≥5% Body Weight Reduction   Week 176 
Change from Baseline in Waist Circumference
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Fasting Glucose
Change from Baseline in Fasting Insulin  		 Baseline, Week 72  
Time to Onset of Type 2 Diabetes  Baseline through Week 176 
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in Triglycerides
hange from Baseline in Low-Density Lipoprotein (LDL) Cholesterol
Change from Baseline in Total Cholesterol
Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol
Change from Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol
Change from Baseline in Free Fatty Acids
Change from Baseline in Systolic Blood Pressure 		 Baseline, Week 72  
Change from Baseline in Diastolic Blood Pressure
Change from Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score 		 Baseline, Week 72 
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide  Baseline through Week 72  
 
Target Sample Size   Total Sample Size="2400"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "2539"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/05/2020 
Date of Study Completion (India) 06/07/2024 
Date of First Enrollment (Global)  04/12/2019 
Date of Study Completion (Global) 06/07/2024 
Estimated Duration of Trial   Years="4"
Months="0"
Days="5" 
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)?  

Brief Summary   This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks (14 visits). Participants with prediabetes will continue in the extension for another 2 years.
 
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