NCT07073417进行中（未招募）2 期
A Multicenter, Randomized, Open-label, Treatment Switching Phase II Study to Evaluate the Efficacy and Safety of XW003 Injection and Semaglutide Injection in Chinese Adults With Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Percentage change in body weight relative to baseline
研究概览
简要总结
The aim of the study is to compare the efficacy and safety of XW003 injection versus semaglutide injection in Chinese adults with obesity
详细描述
In this Phase II study, eligible participants will be randomized into one of the two cohorts in a 1:1 ratio to receive once-weekly subcutaneous XW003 injection or semaglutide injection, including a dose-escalation period, a core treatment period and a treatment extension period, for up to 60 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
- None
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
- •BMI≥30 kg/m2 at screening, waist circumference ≥90 cm for men and ≥85 cm for women.
- •Weight change of less than 5% within 3 months prior to screening (self-reported).
排除标准
- •Diagnosis of obesity due to endocrine disorders or a single gene mutation, including but not limited to hypothalamic obesity, pituitary obesity, Cushing's syndrome, hypothyroidic obesity (except for those with normal thyroid function at screening and expected to remain unchanged throughout the trial period after at least 3 months of thyroid hormone replacement therapy), insulinoma, acromegaly.
- •History of bariatric surgery or planning to undergo bariatric surgery or use other weight-loss drugs or devices during the trial (except acupuncture for weight loss, liposuction, or abdominal fat removal for more than one year before screening; Except the removal or expulsion of the airbag in the stomach for more than 1 year before screening.
- •Diagnosis with any type of diabetes (except gestational diabetes).
- •Have used any weight-loss drugs, hypoglycemic drugs, or drugs that may cause significant weight gain within 3 months prior to screening.
- •History of acute or chronic pancreatitis or pancreatic injury, history of symptomatic gallbladder disease (except cholecystectomy).
- •History of clinically significant gastric emptying abnormalities, such as gastroparesis or gastric outlet obstruction.
研究组 & 干预措施
XW003
Experimental
once weekly
干预措施: XW003 injection (Drug)
semaglutide
Active Comparator
once weekly
干预措施: semaglutide injection (Drug)
结局指标
主要结局
Percentage change in body weight relative to baseline
时间窗: week 48
次要结局
- The change in waist circumference relative to the baseline(week 48)
- Proportions of participants with weight loss ≥5% from baseline(week 48)
- Proportions of participants with weight loss ≥10% from baseline(week 48)
- Proportions of participants with weight loss ≥15% from baseline(week 48)
- Changes in body mass index (BMI) relative to baseline(week 48)
研究者
研究点 (1)
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