A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold) Status: Recruiting
Location: See all (321) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Participation Requirements View:
Inclusion Criteria
Exclusion Criteria
• 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.
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Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Start Date: 2026-06-29
Estimated Completion Date: 2029-07-30
Target number of participants: 4500
Experimental: Arm 1 - Dose 1
Active IMP
Experimental: Arm 2 - Dose 2
Active IMP
Placebo_comparator: Arm 3 - Placebo
Placebo matching elecoglipron