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Clinical Trial ยท PHASE3 ยท Recruiting

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

09 September 2026 NCT07667803 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE3
Participants
ALL
Age Range
18 Years+

About This Trial

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).

Who Can Join?

Inclusion Criteria * Legal age of consent and at least 18 years old * Study 1 – * BMI โ‰ฅ 30 kg/m2 or * 25 kg/m2 โ‰ค BMI < 30 kg/m2 with at least one of the following weight-related comorbidities: * Hypertension * Prediabetes * Dyslipidemia * Cardiovascular disease * Obstructive sleep apnea. * Study 2 – BMI โ‰ฅ 25 kg/m2 and T2DM defined as below: * Established diagnosis of T2DM * Without established diagnosis of T2DM and HbA1c โ‰ฅ 6.5% (48 mmol/mol) at the screening visit * Stable body weight (self-reported or documented) for 90 days prior to the screening visit (ยฑ 5% body weight change) * History of at least one self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria * Study 1 – Established diagnosis of T1DM or T2DM. * Study 2 – Any of the following medical history, laboratory values, or complications related to diabetes:…

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