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NCT Number: NCT07438444

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

B. J. Medical College & Civil Hospital, Ahmedabad, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: 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

Secondary outcomes

  1. Percentage of Participants with ≥5% Body Weight Reduction

    Time frame: Week 46

  2. Percentage of Participants with Hemoglobin A1c (HbA1c) <7.0% in Participants with Type 2 Diabetes

    Time frame: Week 46

  3. Change from Baseline in Waist Circumference in Participants with Obesity or Overweight

    Time frame: Baseline, Week 46

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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