A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity
A Phase 4, Open-Label, Single-Arm, 46-Week Study to Investigate the Safety and Efficacy With Tirzepatide in Adult Indian Participants With Either Type 2 Diabetes or Obesity
2 other identifiers
interventional
344
1 country
21
Brief Summary
The main purpose of this study is to measure the safety and efficacy of tirzepatide in adult participants in India who have type 2 diabetes or who have obesity or overweight without type 2 diabetes. Participation in the study will last about 46 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Feb 2026
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedStudy Start
First participant enrolled
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
May 19, 2026
May 1, 2026
1.6 years
February 23, 2026
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Baseline through Week 46
Secondary Outcomes (3)
Percentage of Participants with ≥5% Body Weight Reduction
Week 46
Percentage of Participants with Hemoglobin A1c (HbA1c) <7.0% in Participants with Type 2 Diabetes
Week 46
Change from Baseline in Waist Circumference in Participants with Obesity or Overweight
Baseline, Week 46
Study Arms (1)
Tirzepatide
EXPERIMENTALParticipants will receive tirzepatide subcutaneously (SC)
Interventions
Eligibility Criteria
You may qualify if:
- Participants with Type 2 Diabetes:
- Have had type 2 diabetes for at least one year
- Insulin naive
- Have HbA1c ≥7.5% and ≤10% at screening
- Have body mass index (BMI) ≥23 kilograms per square meter (kg/m2)
- Participants with Obesity or Overweight without Type 2 Diabetes:
- Have a BMI
- Greater than or equal to 30 kg/m2 OR
- Greater than or equal to 27 kg/m2 AND previously diagnosed with at least one of the following weight-related comorbidities: high blood pressure, lipid disorder, obstructive sleep apnea, heart disease
You may not qualify if:
- Participants with Type 2 Diabetes:
- Have type 1 diabetes
- Have had any of the following heart conditions within 6 months prior to screening:
- heart attack
- stroke
- hospitalization due to heart failure
- Have New York Heart Association Functional Classification Class III or IV congestive heart failure (CHF)
- Have type 2 diabetes along with morbid obesity and being considered for bariatric surgery or any other procedure intended for weight loss
- Participants with Obesity or Overweight without Type 2 Diabetes:
- Have type 1 diabetes or type 2 diabetes
- Have a self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 3 months prior to screening
- Have a prior or planned surgical treatment for obesity
- Have had any of the following heart conditions within 6 months prior to screening:
- heart attack
- stroke
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
B. J. Medical College & Civil Hospital
Ahmedabad, 380 016, India
V.S. General Hospital
Ahmedabad, 380006, India
Gujarat Endocrine Center
Ahmedabad, 380052, India
Jawahar Lal Nehru Medical College
Ajmer, 305001, India
Motilal Nehru Medical College Hospital
Allahābād, 211002, India
Lifecare Hospital and Research Centre
Bengaluru, 560092, India
AIIMS, Bhubaneshwar
Bhubaneswar, 751019, India
Sri Ramachandra MedicaL College & Research Institute
Chennai, 600116, India
Kovai Diabetes Speciality Center and Hospital
Coimbatore, 641009, India
Apollo Excelcare Hospital
Guwahati, 781033, India
Osmania Medical College & Hospital
Hyderabad, 500012, India
Eternal Heart Care Center and Research Institute
Jaipur, 302017, India
K care Hospital
Kanpur, 208001, India
Brij Medical Centre Private Limited
Kanpur, 208020, India
ILS Hospitals
Kolkata, 700064, India
Government Medical College, Kozhikode
Kozhikode, 673008, India
Wockhardt Hospitals
Mumbai, 400011, India
Shri Krishna Hrudayalaya & Critical Care Centre
Nagpur, 440012, India
Sahyadri Super Speciality Hospital
Pune, 411004, India
All India Institute of Medical Sciences
Raipur, 492099, India
King George Hospital, Andhra Medical College
Visakhapatnam, 530002, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2026
First Posted
February 27, 2026
Study Start
February 27, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.