ClinicaliQ Trial Snapshot
- A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM — Recruiting • Phase III • Diabetes / Metabolic • NCT07667803.
- What is being tested: Elecoglipron, a novel therapeutic agent, is being evaluated for efficacy and safety in reducing weight in adults with obesity or overweight, with or without type 2 diabetes mellitus, through two independent Phase III randomised controlled trials comparing the….
- Patient eligibility overview: The trials include adults across global centres with either obesity or overweight status, irrespective of type 2 diabetes mellitus status, enabling assessment across a broad patient population relevant to primary care and specialist settings.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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).
Eligibility Snapshot
- * Legal age of consent and at least 18 years old * Study 1 - * BMI ≥ 30 kg/m2 or * 25 kg/m2 ≤ 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 ≥ 25 kg/m2 and T2DM defined as below: * Established diagnosis of T2DM * Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit * Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change) * History of at least one self-reported unsuccessful dietary effort to lose body weight.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.