jRCT2051240162进行中（未招募）不适用
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 (VISTA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 主要终点
- Percent change in body weight from baseline at Week 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Adults 18 years of age or more.
- •BMI (a) 30 kg/m2 or more, or (b) 27 kg/m2 or more 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.
结局指标
主要结局
Percent change in body weight from baseline at Week 26
时间窗: Week 26
To determine whether AZD5004 is superior to placebo for weight loss
Proportion of participants with weight loss 5% or more from baseline weight at Week 26
时间窗: Week 26
To determine whether AZD5004 is superior to placebo on the proportion of participants with weight loss 5% or more from baseline
次要结局
未报告次要终点
研究者
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