A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Obesity or Overweight With Comorbidity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 262
- 试验地点
- 42
- 主要终点
- Percent change in body weight from baseline to week 26
研究概览
简要总结
A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index [BMI] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity
详细描述
The study will comprise of:
A screening period of maximum 28 days
A treatment period of 36 weeks
A follow up period after last dose of study drug
This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years of age
- •BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27kg/m2 and have a current diagnosis of at least 1 weight-related comorbidities (treated or untreated)
- •A stable body weight for 3 months prior to Screening (±5% body weight change)
排除标准
- •Have obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
- •Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening
- •Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
- •History of type 1 diabetes mellitus or T2DM
研究组 & 干预措施
Arm 4
Placebo - Dose matched with each Experimental arm
干预措施: Placebo comparator (Drug)
Arm 1
Dose 1
干预措施: AZD6234 (Drug)
Arm 2
Dose 2
干预措施: AZD6234 (Drug)
Arm 3
Dose 3
干预措施: AZD6234 (Drug)
结局指标
主要结局
Percent change in body weight from baseline to week 26
时间窗: 26 weeks
To determine whether AZD6234 is superior to placebo for weight loss
Weight loss ≥ 5% from baseline weight to week 26
时间窗: 26 weeks
To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline
次要结局
- Weight loss ≥ 5% from baseline to week 36(36 weeks)
- Weight loss ≥ 10% from baseline to week 36(36 weeks)
- Percent change in body weight from baseline to week 36(36 weeks)
- Absolute change in body weight (kg) from baseline to week 26 and week 36(week 26 and week 36)
- AZD6234 plasma concentrations(Week 43)