A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD5004 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
- 310
- 试验地点
- 1
- 主要终点
- Percent change in body weight from baseline
研究概览
简要总结
A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index [BMI] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity
详细描述
This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 304 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 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
- •Adults ≥ 18 years of age.
- •BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated):
- •(i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea
- •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 monogenic or syndromic obesity such as 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 type 2 diabetes mellitus.
- •Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
- •History of acute or chronic pancreatitis.
研究组 & 干预措施
Arm 1
Active IMP
干预措施: AZD5004 (Drug)
Arm 2
Active IMP
干预措施: AZD5004 (Drug)
Arm 3
Active IMP
干预措施: AZD5004 (Drug)
Arm 4
Active IMP
干预措施: AZD5004 (Drug)
Arm 5
Active IMP
干预措施: AZD5004 (Drug)
Arm 6
Matching placebo for each of the 5 active arms
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in body weight from baseline
时间窗: 26 weeks
To determine whether AZD5004 is superior to placebo for weight loss
Achieved Weight Loss ≥ 5% From Baseline
时间窗: 26 weeks
To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline
次要结局
- Percent change in body weight from baseline(36 weeks)
- Achieved weight loss ≥ 5% from baseline(36 weeks)
- Absolute change from baseline in body weight(Week 26 and Week 36)
- Achieved weight loss ≥ 10% as well as ≥ 15% from baseline(Week 26 and Week 36)