| CTRI Number |
CTRI/2023/11/059873 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study of LY3437943 in Obese or Overweight Patients |
|
Scientific Title of Study
|
A Master Protocol to Investigate the Efficacy and Safety of LY3437943
Once Weekly in Participants without Type 2 Diabetes who have Obesity or
Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial
(TRIUMPH-1) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT05929066 |
ClinicalTrials.gov |
| Protocol No.: J1I-MC-GZBJ(b) dated 21-Apr-2023 |
Protocol Number |
|
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
Brazil
Canada
China
Hungary
India
Mexico
Poland
Republic of Korea
Romania
Spain
Taiwan
United Kingdom
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 Kishore Kumar Behra |
All India Institute of Medical Sciences |
Bhubaneswar, Sijua Patrapada, Odisha, India, 751019
Khordha
ORISSA |
919583644988
kkbaims@gmail.com |
| Dr Tiven Marwah |
Avron Hospitals Pvt. Ltd. |
4, Shantiniketan Park, Nr. Sardar Patel Statue, Naranpura, Ahmedabad, Gujarat, India, 380013
Ahmadabad
GUJARAT |
919824055857
marwahtiven@gmail.com |
| Dr Unnikrishnan Ambika Gopalakrishnan |
Chellaram Diabetes Institute |
1st Floor, Lalani Quantum, Pune Bangalore National Highway 4, Bavdhan (Budruk), Pune, Maharashtra, India, 411021
Pune
MAHARASHTRA |
919689287337
uagcdi@cdi.org.in |
| Dr Nitin Kapoor |
Christian Medical College, Vellore |
810, Dept. Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India, 632004
Vellore
TAMIL NADU |
919585890045
nitin.endocrine@gmail.com |
| Dr Vaishali Chetan Deshmukh |
Deenanath Mangeshkar Hospital & Research Centre |
Endocrinology, Ground Floor, Super Speciality Building, Erandwane, Pandurang Colony, Pune, Maharashtra, India, 411004
Pune
MAHARASHTRA |
919850811450
drvaishaliresearch@gmail.com |
| Dr Kongara Srikanth |
Endolife Speciality Hospitals Pvt. Ltd. |
No. 12-12-94, Old Club Road, Kothapet, Guntur, Andhra Pradesh, India, 522001
Guntur
ANDHRA PRADESH |
919849945577
srikanthendo@gmail.com |
| Dr Sailesh Lodha |
Eternal Hospital, Unit of Eternal Heart Care Center and Research Institute Pvt. Ltd. |
3A, Jagatpura Road, Near Jawahar Circle, Jaipur, Rajasthan, India, 302017
Jaipur
RAJASTHAN |
919829019055
saileshlodha@gmail.com |
| Dr Ghanshyam Goyal |
ILS Hospital, Saltlake |
DD-6 Sector 1, Salt Lake City, Kolkata, West Bengal, India, 700064
Kolkata
WEST BENGAL |
919830400450
drgsgoyal@hotmail.com |
| Dr Puthiyaveettil Khader Jabbar |
Indian Institute of Diabetes |
Pulayanarkotta, Thiruvananthapuram, Kerala, India, 695031
Thiruvananthapuram
KERALA |
919446828766
drjabbar10@gmail.com |
| Dr Jothydev Kesavadev |
Jothydevs Diabetes Research Centre |
JDC Junction, Konkalam Road, Mudavanmugal, Poojappura, Trivandrum, India, 695032
Thiruvananthapuram
KERALA |
919895040055
jothydev@gmail.com |
| Dr Ram S Kaulgud |
Karnataka Institute of Medical Sciences |
Department of Internal Medicine, PB Road, Vidyanagar, Hubballi, Karnataka, India, 580021
Dharwad
KARNATAKA |
918073626873
drkaulgud.kims@gmail.com |
| Dr Amol Laxmanrao Dange |
Lifepoint Multispeciality Hospital |
145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune, Maharashtra, India, 411057
Pune
MAHARASHTRA |
919823912040
amoldange298@gmail.com |
| Dr Vikram Lotwala |
SIDS Hospital & Research Centre, A Unit of SIDS Health Care Private Limited |
Off Ring Road, Near
Shell Petrol Pump, Ring Road-Sosyo Circle Lane, Surat, Gujarat, India, 395002
Surat
GUJARAT |
919662068760
doctorvikram@gmail.com |
| Dr Ramen Goel |
Wockhardt Hospital - Mumbai Central |
1877, Dr Anandrao Nair Marg, Near Agripada, Mumbai Central, Mumbai, Maharashtra, India, 400011
Mumbai
MAHARASHTRA |
919820170673
ramengoel@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Avron Multi Speciality Hospitals Ethics Committee |
Approved |
| Chellaram Diabetes Institute Institutional Ethics committee |
Approved |
| Eternal Heart Care Centre & Research Institute-Institutional Ethics Committee |
Approved |
| ILS Hospital Ethics Committee |
Approved |
| Institutional Ethics Committee Jothydev’s Diabetes Research Centre |
Approved |
| Institutional Ethics Committee of Endolife Speciality Hospitals Private Limited |
Approved |
| Institutional Ethics Committee, All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre |
Approved |
| Institutional Ethics Committee, Indian Institute of Diabetes |
Approved |
| Institutional Ethics Committee, Kartanaka Institute of Medical Sciences (KIMS) |
Approved |
| Institutional Review Board, Christian Medical College - Vellore |
Approved |
| LPR Ethics Committee, Lifepoint Multispecialty Hospital |
Approved |
| Surat Institute of Digestive Sciences Ethics Committee (SIDSEC) |
Approved |
| Wockhardt Hospitals Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E66||Overweight and obesity, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Participants will receive placebo administered subcutaneously (SC) once weekly. The treatment duration will be 80 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 treatment duration will be 80 weeks. |
| Intervention |
Retatrutide Extension period (Optional) |
After the 80-week treatment period, participants will continue receiving retatrutide administered subcutaneously (SC) once weekly, for an additional 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following: hypertension, dyslipidemia
obstructive sleep apnea, or cardiovascular disease
2. History of at least one unsuccessful dietary effort to reduce 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 diabetes mellitus.
5. Have 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 (SBP)
4. Percent Change form Baseline in Fasting Insulin
5. Change from Baseline in HbA1c
6. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score |
Baseline, Week 80 |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) |
Baseline through Week 80 |
|
|
Target Sample Size
|
Total Sample Size="2100"
Sample Size from India="150"
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)
|
18/12/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/07/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="4"
Days="25" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 01-12-2023 and end date provided 31-05-2024?
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 who have obesity or overweight (J1I-MC-GZBJ master protocol). This study will last about 89 weeks and will include up to 24 visits.
|