A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity

Recruiting now · Phase 4

Conditions studied: Diabetes Mellitus, Type 2, Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT07438444

Run by

Eli Lilly and Company

People needed

344

Starts

2026-02-27

Expected to finish

2027-10-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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 it is running

• B. J. Medical College & Civil Hospital — Ahmedabad, India (enrolling)
• Osmania Medical College & Hospital — Hyderabad, India (enrolling)
• Eternal Heart Care Center and Research Institute — Jaipur, India (enrolling)
• K care Hospital — Kanpur, India (enrolling)
• ILS Hospitals — Kolkata, India (enrolling)
• Government Medical College, Kozhikode — Kozhikode, India (enrolling)
• Shri Krishna Hrudayalaya & Critical Care Centre — Nagpur, India (enrolling)
• Sahyadri Super Speciality Hospital — Pune, India (enrolling)
• Gujarat Endocrine Center — Ahmedabad, India (enrolling)
• Motilal Nehru Medical College Hospital — Allahābād, India (enrolling)
• Lifecare Hospital and Research Centre — Bengaluru, India (enrolling)
• Sri Ramachandra MedicaL College & Research Institute — Chennai, India (enrolling)
• Kovai Diabetes Speciality Center and Hospital — Coimbatore, India (enrolling)
• Apollo Excelcare Hospital — Guwahati, India (enrolling)
• V.S. General Hospital — Ahmedabad, India
• Wockhardt Hospitals — Mumbai, India
• Jawahar Lal Nehru Medical College — Ajmer, India
• Brij Medical Centre Private Limited — Kanpur, India
• All India Institute of Medical Sciences — Raipur, India
• AIIMS, Bhubaneshwar — Bhubaneswar, India
• King George Hospital, Andhra Medical College — Visakhapatnam, India

Full record on ClinicalTrials.gov

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