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

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: Active, not recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2; Overweight
• Intervention / Treatment: Drug: Tirzepatide

• Study Type: Interventional
• Enrollment (Estimated): 344
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India, 380006
    • V.S. General Hospital
  • Ahmedabad, India, 380 016
    • B. J. Medical College & Civil Hospital
  • Ahmedabad, India, 380052
    • Gujarat Endocrine Center
  • Ajmer, India, 305001
    • Jawahar Lal Nehru Medical College
  • Allahābād, India, 211002
    • Motilal Nehru Medical College Hospital
  • Bengaluru, India, 560092
    • Lifecare Hospital and Research Centre
  • Bhubaneswar, India, 751019
    • AIIMS, Bhubaneshwar
  • Chennai, India, 600116
    • Sri Ramachandra MedicaL College & Research Institute
  • Coimbatore, India, 641009
    • Kovai Diabetes Speciality Center and Hospital
  • Guwahati, India, 781033
    • Apollo Excelcare Hospital
  • Hyderabad, India, 500012
    • Osmania Medical College & Hospital
  • Jaipur, India, 302017
    • Eternal Heart Care Center and Research Institute
  • Kanpur, India, 208001
    • K care Hospital
  • Kanpur, India, 208020
    • Brij Medical Centre Private Limited
  • Kolkata, India, 700064
    • ILS Hospitals
  • Kozhikode, India, 673008
    • Government Medical College, Kozhikode
  • Mumbai, India, 400011
    • Wockhardt Hospitals
  • Nagpur, India, 440012
    • Shri Krishna Hrudayalaya & Critical Care Centre
  • Pune, India, 411004
    • Sahyadri Super Speciality Hospital
  • Raipur, India, 492099
    • All India Institute of Medical Sciences
  • Visakhapatnam, India, 530002
    • King George Hospital, Andhra Medical College

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	Week 46
Percentage of Participants with Hemoglobin A1c (HbA1c) <7.0% in Participants with Type 2 Diabetes	Week 46
Change from Baseline in Waist Circumference in Participants with Obesity or Overweight	Baseline, Week 46

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): February 27, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 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): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Tirzepatide; Type 2 Diabetes in India; Obesity in India; Obese in India; Tirzepatide in India
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• 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