Clinical Trials in India / NCT07438444
Active, not recruiting
Phase 4
A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity
NCT07438444 · tracked via the Priya Life Science India tracker
Condition(s) studied
Diabetes Mellitus, Type 2ObesityOverweight
Study 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.
Eligibility
Inclusion Criteria:
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
Exclusion Criteria:
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
* hospitalization due to heart failure
* Have New York Heart Association Functional Classification Class III or IV CHF
* Have taken any medications or alternative remedies for weight loss within 3 months prior to screening
Primary outcome measure(s)
- Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration — Baseline through Week 46
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
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| B. J. Medical College & Civil Hospital | Ahmedabad | India | |
| V.S. General Hospital | Ahmedabad | India | |
| Gujarat Endocrine Center | Ahmedabad | India | |
| Jawahar Lal Nehru Medical College | Ajmer | India | |
| Motilal Nehru Medical College Hospital | Allahabād | India | |
| Lifecare Hospital and Research Centre | Bengaluru | India | |
| AIIMS, Bhubaneshwar | Bhubaneswar | India | |
| Sri Ramachandra MedicaL College & Research Institute | Chennai | India | |
| Kovai Diabetes Speciality Center and Hospital | Coimbatore | India | |
| Apollo Excelcare Hospital | Guwahati | India | |
| Osmania Medical College & Hospital | Hyderabad | India | |
| Eternal Heart Care Center and Research Institute | Jaipur | India | |
| K care Hospital | Kanpur | India | |
| Brij Medical Centre Private Limited | Kanpur | India | |
| ILS Hospitals | Kolkata | India | |
| Government Medical College, Kozhikode | Kozhikode | India | |
| Wockhardt Hospitals | Mumbai | India | |
| Shri Krishna Hrudayalaya & Critical Care Centre | Nagpur | India | |
| Sahyadri Super Speciality Hospital | Pune | India | |
| All India Institute of Medical Sciences | Raipur | India | |
| King George Hospital, Andhra Medical College | Visakhapatnam | India |
On this site
📄 Mounjaro (tirzepatide) drug profile →More Eli Lilly and Company trials in India
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07438444 on ClinicalTrials.gov ↗ ← All trials in India