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Trial · Interventional

Active, not recruitingPhase 4Registry data

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

NCTNCT07438444 (opens ClinicalTrials.gov in a new tab)Other id27235Other idI8F-IN-GPIZ
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Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
344 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

India

Start
27 Feb 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
First posted
27 Feb 2026
Last update posted
21 Aug 2026
Conditions
Diabetes Mellitus, Type 2 · Obesity · Overweight

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 4

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

    NCT07438444

    27 Feb 2026 to est. Jul 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug

Arms1

  • Experimental

    Tirzepatide

    Participants will receive tirzepatide subcutaneously (SC)

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    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(3)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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