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

RECRUITINGPhase 4Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 4
SponsorEli Lilly and Company
Started2026-02-27
Est. completion2027-10
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07438444

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

DiabetesDiabetes Mellitus, Type 2ObesityOverweight

Interventions1

Tirzepatide

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