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)
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
Allahābād
India
Lifecare Hospital and Research Centre
Bengaluru
India
AIIMS, Bhubaneshwar
Bhubaneswar
India
Sri Ramachandra MedicaL College & Research Institute
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.
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