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A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

NCT07667803 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4500

Last updated 2026-07-10

No results posted yet for this study

Summary

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).

Conditions

Interventions

DRUG

Elecoglipron

Elecoglipron film-coated tablet once daily

DRUG

Placebo

Placebo matching elecoglipron film-coated tablet once daily

Sponsors & Collaborators

Principal Investigators

  • Dr. Ania Jastreboff, MD, PhD · Yale University

  • Prof. Melanie Davies, MBChB · Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-29
Primary Completion
2028-07-31
Completion
2029-07-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • China
  • Germany
  • India
  • Italy
  • Japan
  • Poland
  • Saudi Arabia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07667803 on ClinicalTrials.gov