| CTRI Number |
CTRI/2023/10/058324 [Registered on: 05/10/2023] 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 Trial |
|
Public Title of Study
|
A Study of LY3437943 in Participants with Type 2 Diabetes Mellitus who have Obesity or Overweight |
|
Scientific Title of Study
|
A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants with Type 2 Diabetes Mellitus who have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-2) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| J1I-MC-GZBK(a) protocol dated 21 April 2023 |
Protocol Number |
| NCT05929079 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| 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
Modification(s)
|
| 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 |
09810308697 |
| 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
|
|
|
Countries of Recruitment
|
Australia
China
India
Mexico
Republic of Korea
Romania
Spain
Taiwan
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Sabah Siddiqui |
All India Institute of Medical Sciences, Raipur |
All India Institute of Medical Sciences, Department of Medicine, Great Eastern Road, Opposite Gurudwara, AIIMS Campus, Tatibandh Raipur – 492099, Chhattisgarh, India
Raipur
CHHATTISGARH |
918518881911
dr.sabahsiddiqui@gmail.com |
| Dr Tiven Marwah |
Avron Hospitals Pvt. Ltd. |
Avron Hospitals Pvt. Ltd., 4, Shantiniketan Park, Nr. Sardar Patel Statue, Naranpura, Ahmedabad, Gujarat, India, 380013
Ahmadabad
GUJARAT |
8401522025
marwahtiven@gmail.com |
| Dr Sandeep Julka |
CARE CHL-Hospitals (Unit of Convenient Hospitals Ltd.) |
CARE CHL-Hospitals [Unit of Convenient Hospitals Ltd.], Near L.I.G. Square, A.B. Road, Indore, Madhya Pradesh, India, 452008
Indore
MADHYA PRADESH |
9977999687
sandeep_julka@yahoo.com |
| Dr Bipin Kumar Sethi |
CARE Out Patient Center, Care Hospitals Hyderabad – Banjara Hills |
CARE Hospitals, CARE Out Patient Center, 8-2-620/A-E, Road Number 10, Banjara Hills, Hyderabad, Telangana, India, 500034
Hyderabad
TELANGANA |
919440739238
sethibipin54@gmail.com |
| Dr Nihal Thomas |
Christian Medical College, Vellore |
810, Dept of Endocrinology Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India, 632004
Vellore
TAMIL NADU |
9843111996
nihal_thomas@yahoo.com |
| Dr Paturi Vishnupriya Rao |
Diabetes Research Center |
6.3.349.17B and 31, Dwarakapuri, Panjagutta, Hyderabad - 500082, Telangana, India
Hyderabad
TELANGANA |
919885051110
raopaturi@gmail.com |
| Dr Sujoy Ghosh |
Institute of Post Graduate Medical Education and Research |
Institute of Post Graduate Medical Education and Research, Department of Endocrinology, 244 A.J.C Bose Road, Kolkata, West Bengal, India, 700020
Kolkata
WEST BENGAL |
919674625823
drsujoyghosh2000@gmail.com |
| Dr Sumaiya Anjum |
K R Hospital (Mysore Medical College and Research Institute) |
K R Hospital, Attached to Mysore Medical College and Research Institute, Department of Medicine, Irwin Road, Mysuru – 570001 Karnataka, India.
Mysore
KARNATAKA |
7760218464
dr.sumaiyaanjum@gmail.com |
| Dr L Sreenivasa Murthy |
Life Care Hospital and Research Centre |
Life Care Hospital and Research Centre,
2748/2152 M.L.N Enclave, 16th East Cross Road, 8th Main, D block, Next to Union Bank of India, Sahakarnagara, Bangalore, Karnataka, India, 560092
Bangalore
KARNATAKA |
919448051046
drlsm@lcrc.in |
| Dr Viswanathan Mohan |
Madras Diabetes Research Foundation |
Madras Diabetes Research Foundation,
4 Conran Smith Road, Gopalapuram Chennai, Tamil Nadu, India, 600086
Chennai
TAMIL NADU |
919840134505
drmohans@diabetes.ind.in |
| Dr Sandeep Kumar Mathur |
S.M.S Medical College and Hospital |
Department of Endocrinology, S.M.S Medical College and Attached Hospital, JLN Marg, Jaipur – 302004
Jaipur
RAJASTHAN |
919414048666
drsandeepmathur@rediffmail.com |
| Dr Dhaiwat Shukla |
Sheth Vadilal Sarabhai General Hospital |
Sheth Vadilal Sarabhai General Hospital, Madalpur Gam, Paldi Road, Ellis Bridge, Ahmedabad, Gujarat, India, 380006
Ahmadabad
GUJARAT |
8980024107
dr.dhaiwatshukla89@gmail.com |
| Dr Raghavendra N Belgaonkar |
Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd. |
Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd., P.B. Road, Vidyanagar, Hubballi Dharwad, Karnataka - 580021
Dharwad
KARNATAKA |
9449864825
drbelgaonkar.sushruta@gmail.com |
| Dr Vitthal Nathubhai Shah |
Zydus Hospitals & Healthcare Research Pvt. Ltd. |
Zydus Hospitals & Healthcare Research Pvt. Ltd., Zydus Hospital Road, S.G. Highway, Thaltej, Ahmedabad, Gujarat, India, 380054
Ahmadabad
GUJARAT |
919825067065
vnshah@zydushospitals.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Avron Multi Speciality Hospitals Ethics Committee |
Approved |
| CARE Hospitals, Institutional Ethics Committee |
Approved |
| Ethics Committee, S.M.S. Medical College and Attached Hospitals |
Not Applicable |
| IEC of Madras Diabetes Research Foundation |
Approved |
| INSTITUTE ETHICS COMMITTEE, AIIMS RAIPUR |
Approved |
| Institutional Ethics Committee – Mysore Medical College and Research Institute and Associated Hospitals |
Approved |
| Institutional Ethics Committee, Diabetes Research Center |
Approved |
| Institutional Review Board, Christian Medical College |
Approved |
| Integrity Ethical Committee, CHL-Hospitals |
Approved |
| IPGME and Research Oversight Committee |
Approved |
| Life Care Hospital Institutional Review Board |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sushruta Hospital Ethics Committee |
Approved |
| Zydus Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
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 89 weeks. |
| 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 89 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m²)
2. Have Type 2 Diabetes (T2D)
3. Are on stable treatment for T2D for at least 90 days
4. Have a history of at least one unsuccessful dietary effort to lose body weight |
|
| ExclusionCriteria |
| Details |
1. Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days
2. Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
3. Have a prior or planned surgical treatment for obesity
4. Have Type 1 diabetes.
5. Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
6. Have had pancreatitis
|
|
|
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 |
Baseline, Week 80 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change from Baseline in Body Mass Index (BMI)
2. Change from Baseline in Waist Circumference
3. Change from Baseline in Systolic Blood Pressure
4. Change from Baseline in Diastolic Blood Pressure
5. Change from Baseline in Total Cholesterol
6. Change from Baseline in Triglycerides
7. Change from Baseline in Hemoglobin A1c (HbA1c)
8. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
9. Change from Baseline in fasting glucose
|
Baseline, Week 80 |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) |
Baseline through Week 80 |
|
|
Target Sample Size
|
Total Sample Size="1000"
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)
|
20/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/07/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="11" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - www.vivli.org
- For how long will this data be available start date provided 01-11-2023 and end date provided 30-04-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes who have obesity or overweight (J1I-MC-GZBK master protocol). The study will last about 89 weeks and will include up to 24 visits. |