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)
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)
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.
Inclusion Criteria
Legal age of consent and at least 18 years old
Study 1 -
Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below:
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.
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:
History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis
History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2
information.center@astrazeneca.com1-877-240-9479
CABA, 1056, Argentina
CABA, C1120AAC, Argentina
Caba, C1128AAF, Argentina
Capital Federal, C1014A, Argentina
North York, Ontario M6B 3H7, Canada
Araucania, 4781151, Chile
Huaian, 223300, China
Amagasaki-shi, 660-0861, Japan
Kasugai-shi, 486-8510, Japan
Koga-shi, 306-0232, Japan
Shinjuku-ku, 169-0072, Japan
Suita-shi, 564-8565, Japan
Suita-shi, 565-0853, Japan
Toshima-ku, 171-0014, Japan
Yamato-shi, 242-0004, Japan
Al-Ahsa, 36428, Saudi Arabia
Jongno-gu, 110-746, South Korea
Tainan County, 71044, Taiwan