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

May 18, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

344

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • India
      • Ahmedabad, India, 380 016
        • Recruiting
        • B. J. Medical College & Civil Hospital
        • Principal Investigator:
          • Kartikeya Parmar
        • Contact:
          • Phone Number: 9586974089
      • Ahmedabad, India, 380006
        • Not yet recruiting
        • V.S. General Hospital
        • Principal Investigator:
          • DHAIWAT SHUKLA
        • Contact:
          • Phone Number: 9426641888
      • Ahmedabad, India, 380052
        • Recruiting
        • Gujarat Endocrine Center
        • Principal Investigator:
          • parag Shah
        • Contact:
          • Phone Number: 9825599450 and 9428044608
      • Ajmer, India, 305001
        • Not yet recruiting
        • Jawahar Lal Nehru Medical College
        • Contact:
          • Phone Number: 7737258659
        • Principal Investigator:
          • Sanjeev Maheshwari
      • Allahābād, India, 211002
        • Recruiting
        • Motilal Nehru Medical College Hospital
        • Principal Investigator:
          • JITENDRA SHUKLA
        • Contact:
          • Phone Number: 7007590702
      • Bengaluru, India, 560092
        • Recruiting
        • Lifecare Hospital and Research Centre
        • Principal Investigator:
          • Sreenivasa Murthy
        • Contact:
          • Phone Number: 9663370338
      • Bhubaneswar, India, 751019
        • Not yet recruiting
        • AIIMS, Bhubaneshwar
        • Contact:
          • Phone Number: 7327030798 6370421141
        • Principal Investigator:
          • Debananda Sahoo
      • Chennai, India, 600116
        • Recruiting
        • Sri Ramachandra MedicaL College & Research Institute
        • Contact:
          • Phone Number: 044-45928916
        • Principal Investigator:
          • Sudagar Singh
      • Coimbatore, India, 641009
        • Recruiting
        • Kovai Diabetes Speciality Center and Hospital
        • Principal Investigator:
          • Balamurugan Ramanathan
        • Contact:
          • Phone Number: 9444548713
      • Guwahati, India, 781033
        • Recruiting
        • Apollo Excelcare Hospital
        • Principal Investigator:
          • Manash Baruah
        • Contact:
          • Phone Number: 9085174978
      • Hyderabad, India, 500012
        • Recruiting
        • Osmania Medical College & Hospital
        • Principal Investigator:
          • Rakesh Sahay
        • Contact:
          • Phone Number: 9000464657 9652050894
      • Jaipur, India, 302017
        • Recruiting
        • Eternal Heart Care Center and Research Institute
        • Principal Investigator:
          • Jugal Gupta
        • Contact:
          • Phone Number: 9982021057
      • Kanpur, India, 208001
        • Recruiting
        • K care Hospital
        • Principal Investigator:
          • Amit Gupta
        • Contact:
          • Phone Number: 9557808393
      • Kanpur, India, 208020
        • Not yet recruiting
        • Brij Medical Centre Private Limited
        • Principal Investigator:
          • Brij Mohan
        • Contact:
          • Phone Number: 8009626511
      • Kolkata, India, 700064
        • Recruiting
        • ILS Hospitals
        • Principal Investigator:
          • Ghanshyam Goyal
        • Contact:
          • Phone Number: 9831058704
      • Kozhikode, India, 673008
        • Recruiting
        • Government Medical College, Kozhikode
        • Principal Investigator:
          • Rojith Balakrishnan
        • Contact:
          • Phone Number: 9778730848
      • Mumbai, India, 400011
        • Not yet recruiting
        • Wockhardt Hospitals
        • Principal Investigator:
          • Ramen Goel
        • Contact:
          • Phone Number: 8975247275
      • Nagpur, India, 440012
        • Recruiting
        • Shri Krishna Hrudayalaya & Critical Care Centre
        • Principal Investigator:
          • Mahesh Fulwani
        • Contact:
          • Phone Number: 7020875496
      • Pune, India, 411004
        • Recruiting
        • Sahyadri Super Speciality Hospital
        • Principal Investigator:
          • Shashank Shah
        • Contact:
          • Phone Number: 9503105354
      • Raipur, India, 492099
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Sabah Siddiqui
        • Contact:
          • Phone Number: 9408388382
      • Visakhapatnam, India, 530002
        • Not yet recruiting
        • King George Hospital, Andhra Medical College
        • Contact:
          • Phone Number: 8555976042 7075852341
        • Principal Investigator:
          • Valluri Prasad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide
Participants will receive tirzepatide subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline through Week 46

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with ≥5% Body Weight Reduction
Time Frame: Week 46
Week 46
Percentage of Participants with Hemoglobin A1c (HbA1c) <7.0% in Participants with Type 2 Diabetes
Time Frame: Week 46
Week 46
Change from Baseline in Waist Circumference in Participants with Obesity or Overweight
Time Frame: Baseline, Week 46
Baseline, Week 46

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27235
  • I8F-IN-GPIZ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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