RecruitingPhase 4

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

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

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

344

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥23•HbA1c 7.5-10%

Primary endpoint

•Serious AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07438444

Org study ID27235

Secondary IDI8F-IN-GPIZEli Lilly and Company

Timeline

Milestones

Study first posted2026-02-27actual

Study start2026-02-27actual

Last update posted2026-05-19actual

Primary completion2027-10estimated (month precision)

Study completion2027-10estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot 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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Percentage of Participants with ≥5% Body Weight Reduction

Time frame:Week 46

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 46

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

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

Time frame:Week 46

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

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

Serious AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.