Ireland
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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
Phase
Phase 4
Started
2026-02-27
Last updated
2026-08-21

Condition(s) studied

Diabetes Mellitus, Type 2ObesityOverweight

Investigational drug(s) / intervention(s)

Tirzepatide →

Tirzepatide: Administered SC

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
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