A Phase 3 interventional study of Elecoglipron and Placebo in Obesity and Overweight, sponsored by AstraZeneca. Recruiting at 49 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of oral elecoglipron in adults with obesity or overweight, with or without type 2 diabetes mellitus. Participants will be randomized to receive elecoglipron or placebo in accordance with the study protocol. Efficacy and safety will be assessed throughout the study.
Exclusion Criteria:
Active IMP
Drug: Elecoglipron
Active IMP
Drug: Elecoglipron
Placebo matching elecoglipron
Drug: Placebo
Elecoglipron film coated tablet once daily
Placebo matching elecoglipron film-coated tablet once daily
Percent change from baseline to Week 52 in body weight
Percent change from baseline to Week 52 in body weight.
Time frame: Week 52
Participants achieving at least 5% body weight loss at Week 52
Achieved at least 5% body weight loss from baseline at Week 52.
Time frame: Week 52
Participants achieving at least 10% body weight loss at Week 52
Achieved at least 10% body weight loss from baseline at Week 52.
Time frame: Week 52
Change in waist circumference from baseline to Week 52
Absolute change from baseline to Week 52 in waist circumference(cm).
Time frame: Week 52
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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