NCT07255209招募中3 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of IBI362 in Chinese Adolescents With Obesity or Overweight（GLORY-YOUNG）
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Percent Change from Baseline in BMI
研究概览
简要总结
The study is designed to assess the efficacy and safety of multiple doses of IBI362 in Chinese adolescent subjects with obesity or overweight. It plans to enroll 180 adolescents (aged ≥12 and <18 years) who have failed to achieve a 5 kg weight reduction after at least 12 weeks of dietary and exercise intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 否
入选标准
- •Participants must meet all of the following inclusion criteria to be enrolled:
- •Key Inclusion Criteria：
- •Male or female participants aged ≥12 years and <18 years at the time of signing the informed consent/assent form.
- •BMI at screening meeting the obesity criteria defined by "WS/T 586-2018 Screening for Overweight and Obesity in School-Age Children and Adolescents" or meeting overweight criteria plus at least one weight-related comorbidity: prediabetes, type 2 diabetes, hypertension, dyslipidemia, fatty liver disease, or obstructive sleep apnea syndrome.
- •Weight change <5 kg after ≥12 weeks of diet and exercise alone before screening (per self/parental report).
排除标准
- •Prior diagnosis of type 1 diabetes.
- •Pre-pubertal participants (Tanner Stage I).
- •History of (or planned) bariatric surgery (except liposuction/abdominoplasty or acupuncture for weight loss performed >1 year before screening).
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
IBI362-dose2
Experimental
干预措施: IBI362 (Drug)
IBI362-dose1
Experimental
干预措施: IBI362 (Drug)
结局指标
主要结局
Percent Change from Baseline in BMI
时间窗: Week 32
次要结局
- Percentage of Participants with ≥5% BMI Reduction(Week 32)
- Percentage of Participants with ≥5% BMI Reduction(Week 52)
- Percent Change from Baseline in BMI(Week 52)
研究者
研究点 (1)
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