NCT07143227已完成1 期
A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of XW003 Injection in Chinese Adolescents With Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number and severity of adverse events
研究概览
简要总结
The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XW003 injection in Chinese adolescents with obesity
详细描述
In this study, eligible participants will be randomized into one of the three cohorts in a 3:1 ratio to receive either once-weekly subcutaneous XW003 injection or placebo, for up to 20 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At the time of screening, BMI meets the obesity criteria specified in WS/T586-2018 'screening for overweight and obesity among school-aged children and adolescents', and weight ≥55 kg;
- •At the time of screening, the decrease of body mass index less than 5% after diet and exercise control alone for at least 12 weeks (as reported by participants or parents or legal guardians);
排除标准
- •Pre-adolescent participants (Tanner phase I);
- •Obesity caused by secondary diseases or medications, including: elevated cortisol hormone (e.g. Cushing's syndrome), damage to the pituitary gland and hypothalamus, reduced dosage/discontinuation of weight-loss drugs or monogenic obesity, etc.;
- •Have used any weight-loss drugs, hypoglycemic drugs, or drugs that may cause significant weight gain within 3 months prior to screening;
- •Diagnosis with any type of diabetes;
- •History of acute or chronic pancreatitis, history of gallbladder disease or pancreatic injury
研究组 & 干预措施
placebo
Placebo Comparator
once weekly
干预措施: placebo with matching volume (Drug)
XW003 Dose 1
Experimental
once weekly
干预措施: XW003 injection (Drug)
XW003 Dose 2
Experimental
once weekly
干预措施: XW003 injection (Drug)
XW003 Dose 3
Experimental
once weekly
干预措施: XW003 injection (Drug)
结局指标
主要结局
Number and severity of adverse events
时间窗: week 20
次要结局
- Change of body weight from baseline(week 20)
- Plasma concentrations of XW003(week 20)
- Change of body weight from baseline(week 20)
研究者
研究点 (1)
Loading locations...
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