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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 4,500
- 试验地点
- 441
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Study 1 - Established diagnosis of T1DM or T2DM.
- •Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:
- •HbA1c ≥ 10% (86 mmol/mol) at the screening visit
- •Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
- •Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- •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
研究组 & 干预措施
Arm 3 - Placebo
Placebo matching elecoglipron
干预措施: Placebo (Drug)
Arm 1 - Dose 1
Active IMP
干预措施: Elecoglipron (Drug)
Arm 2 - Dose 2
Active IMP
干预措施: Elecoglipron (Drug)