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Recruiting NCT07438444

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

Phase IV Interventional Diabetes Mellitus, Type 2 Obesity Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tirzepatide.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2, Obesity, Overweight. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Drug Tirzepatide
    Administered SC

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Percentage of Participants with ≥5% Body Weight Reduction [Time frame: Week 46]
  • Percentage of Participants with Hemoglobin A1c (HbA1c) <7.0% in Participants with Type 2 Diabetes [Time frame: Week 46]
  • Change from Baseline in Waist Circumference in Participants with Obesity or Overweight [Time frame: Baseline, Week 46]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

India · 21 centers
  • B. J. Medical College & Civil Hospital — Ahmedabad
  • V.S. General Hospital — Ahmedabad
  • Gujarat Endocrine Center — Ahmedabad
  • Jawahar Lal Nehru Medical College — Ajmer
  • Motilal Nehru Medical College Hospital — Allahābād
  • Lifecare Hospital and Research Centre — Bengaluru
  • AIIMS, Bhubaneshwar — Bhubaneswar
  • Sri Ramachandra MedicaL College & Research Institute — Chennai
  • … and 13 more centers

Identifiers

NCT: NCT07438444 · 27235 · I8F-IN-GPIZ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗