← Human Trials & Peer-Reviewed Studies
A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity
Plain-language guide to NCT07438444: phase 4 interventional trial of Tirzepatide, 344 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07438444
- Phase
- phase 4
- Status
- active, not recruiting
- Start
- 2026-02-27
- Completion (planned or actual)
- 2027-07
- Participants
- 344 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2; Obesity; Overweight
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Tirzepatide.
Participation in the study will last about 46 weeks.
It had 1 arm (groups): Tirzepatide (experimental).
Participants will receive tirzepatide subcutaneously (SC).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 344 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have had type 2 diabetes for at least one year. Have body mass index (BMI) ≥23 kilograms per square meter (kg/m2). 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.
The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: have type 1 diabetes; have had any of the following heart conditions within 6 months prior to screening:; heart attack.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2026-02-27 with completion listed for 2027-07.
It ran at 21 sites in India (21).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): 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).
It also tracked 3 secondary outcomes, for example Change from Baseline in Waist Circumference in Participants with Obesity or Overweight.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Tirzepatide in 344 people.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tirzepatide compound page, all human trials.
Our Notes on the Compound
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.