Tirzepatide for adults in India with type 2 diabetes or with overweight/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
This study will test whether tirzepatide helps adults in India who have type 2 diabetes or who are overweight or obese without diabetes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 344 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 21 sites (Ahmedabad and 20 other locations) |
| Trial ID | NCT07438444 on ClinicalTrials.gov |
What this trial studies
This is a phase 4 interventional study sponsored by Eli Lilly that gives tirzepatide to adult participants in India and follows them for about 46 weeks to measure safety and effectiveness. The study enrolls two groups: insulin‑naive adults with type 2 diabetes (duration ≥1 year, HbA1c 7.5–10%, BMI ≥23 kg/m2) and adults with obesity or overweight without diabetes (BMI ≥30 kg/m2 or ≥27 kg/m2 with a weight‑related comorbidity). Participants will attend regular clinic visits at study sites in Ahmedabad for monitoring of side effects, weight, and blood glucose control. Results will inform how tirzepatide performs in an Indian adult population.
Who should consider this trial
Good fit: Adults in India who are either insulin‑naive with type 2 diabetes for at least one year (HbA1c 7.5–10% and BMI ≥23 kg/m2) or adults with obesity/overweight (BMI ≥30 kg/m2, or ≥27 kg/m2 with a weight‑related comorbidity) and who can attend study visits are ideal candidates.
Not a fit: People with type 1 diabetes, recent heart attack or stroke within six months, advanced heart failure (NYHA class III/IV), or those being considered for bariatric surgery are excluded and unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, tirzepatide could improve blood sugar control and produce meaningful weight loss, potentially lowering future health risks.
How similar studies have performed: Previous global trials of tirzepatide have shown substantial weight loss and improved glycemic control, so this study extends those findings to an Indian population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ahmedabad and 20 other locations
- B. J. Medical College & Civil Hospital — Ahmedabad, India (Recruiting)
- V.S. General Hospital — Ahmedabad, India (Not_yet_recruiting)
- Gujarat Endocrine Center — Ahmedabad, India (Recruiting)
- Jawahar Lal Nehru Medical College — Ajmer, India (Not_yet_recruiting)
- Motilal Nehru Medical College Hospital — Allahābād, India (Recruiting)
- Lifecare Hospital and Research Centre — Bengaluru, India (Recruiting)
- AIIMS, Bhubaneshwar — Bhubaneswar, India (Not_yet_recruiting)
- Sri Ramachandra MedicaL College & Research Institute — Chennai, India (Recruiting)
- Kovai Diabetes Speciality Center and Hospital — Coimbatore, India (Recruiting)
- Apollo Excelcare Hospital — Guwahati, India (Recruiting)
- Osmania Medical College & Hospital — Hyderabad, India (Recruiting)
- Eternal Heart Care Center and Research Institute — Jaipur, India (Recruiting)
- K care Hospital — Kanpur, India (Recruiting)
- Brij Medical Centre Private Limited — Kanpur, India (Not_yet_recruiting)
- ILS Hospitals — Kolkata, India (Recruiting)
- Government Medical College, Kozhikode — Kozhikode, India (Recruiting)
- Wockhardt Hospitals — Mumbai, India (Not_yet_recruiting)
- Shri Krishna Hrudayalaya & Critical Care Centre — Nagpur, India (Recruiting)
- Sahyadri Super Speciality Hospital — Pune, India (Recruiting)
- All India Institute of Medical Sciences — Raipur, India (Not_yet_recruiting)
- King George Hospital, Andhra Medical College — Visakhapatnam, India (Not_yet_recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.