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).
This is a Phase III, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 2 doses of elecoglipron compared with placebo, given once daily as oral tablets. This protocol covers two independent pivotal studies in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 25 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Prediabetes, Dyslipidemia, CV disease and/or Obstructive sleep apnea) without T2DM (Study 1) and as well as those who are living with obesity or overweight with T2DM (Study 2). Approximately 3000 participants will be randomized in the study 1 and 1500 participants in the study 2. The primary endpoint is percent change in body weight from baseline at 72 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4,500
Elecoglipron film-coated tablet once daily
Placebo matching elecoglipron film-coated tablet once daily
Research Site
Birmingham, Alabama, United States
NOT_YET_RECRUITINGResearch Site
Dothan, Alabama, United States
RECRUITINGResearch Site
Chandler, Arizona, United States
RECRUITINGResearch Site
Sun City, Arizona, United States
Percent body weight loss
Percent change from baseline to Week 72 in body weight
Time frame: 72 weeks
Absolute body weight loss
Absolute change from baseline to Week 72 in body weight (kg)
Time frame: 72 weeks
Total body weight loss of at least 5%, 10%, and 15%
* Achieved ≥ 5% body weight loss from baseline at Week 72 * Achieved ≥ 10% body weight loss from baseline at Week 72 * Achieved ≥ 15% body weight loss from baseline at Week 72
Time frame: 72 weeks
Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline
Percent change from baseline to Week 72 in body weight
Time frame: 72 weeks
Waist circumference reduction
Absolute change from baseline to Week 72 in waist circumference (cm)
Time frame: 72 weeks
Glycemic control
Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%)
Time frame: 72 weeks
Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline
Achieved normoglycemia (HbA1c \< 5.7% \[39 mmol/mol\]) at Week 72
Time frame: 72 weeks
Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline
* Achieved HbA1c \< 7.0% (53 mmol/mol) at Week 72 * Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72
Time frame: 72 weeks
Systolic blood pressure reduction
Change from baseline to Week 72 in systolic blood pressure (mmHg)
Time frame: 72 weeks
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Research Site
Little Rock, Arkansas, United States
RECRUITINGResearch Site
Lynwood, California, United States
RECRUITINGResearch Site
Rolling Hills Estates, California, United States
NOT_YET_RECRUITINGResearch Site
Sacramento, California, United States
RECRUITINGResearch Site
Arvada, Colorado, United States
RECRUITINGResearch Site
New Haven, Connecticut, United States
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