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CTRI Number  CTRI/2024/10/075621 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 18/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of Retatrutide on Adult Patients with Diabetes 
Scientific Title of Study   A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared with Placebo in Adult Participants with Type 2 Diabetes and Inadequate Glycemic Control with Diet and Exercise Alone (TRANSCEND-T2D-1) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT06354660  ClinicalTrials.gov 
Protocol No.: J1I-MC-GZBY Protocol Date 29-NOV-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manish Mistry 
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  manish.mistry@lilly.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Mistry 
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  manish.mistry@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

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, Sec - 32, Institutional Area, Gurgaon, Haryana-122001 India  
 
Primary Sponsor  
Name  Eli Lilly Company (India) Pvt. Ltd. 
Address  Eli Lilly and Company (India) Pvt. Ltd., Plot No. 92, Sector-32, Institutional Area, Gurgaon, Haryana - 122001 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Mexico
United States of America  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amritava Ghosh  All India Institute of Medical Sciences  Great Eastern Road, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh, India, 492099
Raipur
CHHATTISGARH 		 919547108310

amritava_ghosh@yahoo.co.in 
Dr Kishore Kumar Behera  All India Institute of Medical Sciences  Patrapada, Sijua, Bhubaneswar, 751019, Odisha, India
Khordha
ORISSA 		 9583644988

kkbaims@gmail.com 
Dr Brij Mohan  Brij Medical Centre Private Limited  94-E, Near Panki Police Station, Gangaganj Colony, Kanpur, Uttar Pradesh, India, 208020
Kanpur Nagar
UTTAR PRADESH 		 919415043732

drbrijmohanbmc@gmail.com 
Dr Jugal Bihari Gupta  Eternal Heart Care Center and Research Institute  3A, Jagatpura Road, Near Jawahar Circle, Jaipur, Rajasthan, India, 302020
Jaipur
RAJASTHAN 		 919829414680

drjbgupta@gmail.com 
Dr Chandni R  Government Medical College – Kozhikode  Calicut, Kozhikode, Kerala, India, 673008
Kozhikode
KERALA 		 919447202748

drchandni2019@gmail.com 
Dr Parag Rajnikant Shah  Gujarat Endocrin Pvt Ltd  Gurukul Metro Road,518-526 aws-3 Bldg, Opp to Manav Mandir, Besides Gandhi labor institute, Near Drive cinema, Ahmedabad, Gujarat, India, 380052
Ahmadabad
GUJARAT 		 919824042688

paragendo@gmail.com 
Dr Piyush H Desai  Nirmal Hospital Pvt Ltd.  Ring Road, Surat, Gujarat, India, 395002
Surat
GUJARAT 		 919825144453

drpiyushdesai@gmail.com 
Dr Sivaranjani Holigi  Victoria Hospital, Bangalore Medical College And Research Institute  Room 322, 3rd Floor, OPD Block Fort, K.R.Road Bangalore, Karnataka, India, 560002
Bangalore
KARNATAKA 		 917483559080

drsivaranjanibmcri@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Eternal Heart Care Centre and Research Institute - Institutional Ethics Committee  Approved 
Ethics Committee Brij Medical Centre  Approved 
Ethics Committee of BMCRI  Approved 
Institute Ethics Committee, AIIMS Raipur  Approved 
Institutional Ethics Committee, AIIMS Bhubaneswar   Approved 
Institutional Ethics Committee, Government Medical College - Kozhikode  Approved 
Nirmal Hospital Ethics Committee  Approved 
Sangini Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Placebo  Participants will receive placebo administered subcutaneously (SC) once weekly. The study will last about 11 months. 
Intervention  Retatrutide  Participants will receive retatrutide at dose level 1 (low dose), dose level 2 (medium dose), or dose level 3 (high dose) administered subcutaneously (SC) once weekly. The study will last about 11 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Have Type 2 Diabetes (T2D)
2. Have HbA1c between 7.0% to 9.5%
3. Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening
4. Are of stable weight for at least 90 days prior to screening
5. Have a Body Mass Index (BMI) greater than 23.0 kilograms per meter squared 
 
ExclusionCriteria 
Details  1. Have Type 1 Diabetes (T1D)
2. Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
3. Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
4. Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
5. Have an estimated glomerular filtration rate (eGFR) less tham 15 milliliters/minute/1.73 meter squared as determined by the central laboratory
6. Have a prior or planned surgical treatment for obesity
7. Have New York Heart Association Functional Classification IV congestive heart failure
8. Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
9. Have a known clinically significant gastric emptying abnormality
10. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
11. Have any lifetime history of a suicide attempt
12. Had chronic or acute pancreatitis
13. Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2
14. Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Change from Baseline in Hemoglobin A1c (HbA1c) (%)  Baseline, Week 40 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percentage of Participants Who Achieve HbA1c greater than 7.0%
2. Percentage of Participants Who Achieve HbA1c greater than 6.5%
3. Percentage of Participants Who Achieve HbA1c greater than 5.7%
4. Change from Baseline in Fasting Serum Glucose
5. Percent Change from Baseline in Body Weight
6. Change from Baseline in Body Weight
7. Percentage of Participants Who Achieve Weight Reduction of greater than 5%
8. Percentage of Participants Who Achieve Weight Reduction of greater than 10%
9. Percentage of Participants Who Achieve Weight Reduction of greater than 15%
10. Percentage of Participants Who Achieve HbA1c less than 6.5% and greater than 10% Weight Reduction
11. Percent Change from Baseline in Triglycerides
12. Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol
13. Change from Baseline in Systolic Blood Pressure (SBP) 		 1. Week 40
2. Week 40
3. Week 40
4. Baseline, Week 40
5. Baseline, Week 40
6. Baseline, Week 40
7. Week 40
8. Week 40
9. Week 40
10. Week 40
11. Baseline, Week 40
12. Baseline, Week 40
13. Baseline, Week 40 
 
Target Sample Size   Total Sample Size="480"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   09/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
Days="5" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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 01-12-2024 and end date provided 31-05-2025?
    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   The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits. 
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