NCT06164873进行中（未招募）3 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of IBI362 9 mg in Chinese Participants With Obesity (GLORY-2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 462
- 试验地点
- 1
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female, age 18 years or older at the time of signing informed consent
- •Have a BMI ≥30 kg/m2
- •Have a history of at least one self-reported unsuccessful dietary effort to lose body weight
- •For subjects with T2D at screening:
- •Have a diagnosis of T2D according to the WHO classification above or equal to 3 months prior to the day of screening
- •Treated with either diet and excercise alone or on stable treatment with up to 3 oral antidiabetic medications alone or in any combination (EXCEPT GLP-1R agonists or DPP-4 inhibitors) for at least 2 months prior to the day of screening
- •HbA1c 7.0-10.0% (both inclusive) at screening
- •Fasting blood glucose ≤11.1 mmol/L at screening
排除标准
- •A self-reported change in body weight above 5% within 3 months before screening
- •For subjects without T2D at screening:
- •HbA1c ≥6.5% as measured by local laboratory at screening
- •For subjects with T2D at screening:
- •Have history of proliferative diabetic retinopathy, diabetic macular edema or non-proliferative diabetic retinopathy that required acute treatment
- •Have had 2 or more episodes of ketoacidosis, hyperosmolar state or lactic acidosis within 6 months before screening;
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
IBI362
Experimental
干预措施: IBI362 (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Week 60
Proportion of Participants who Achieve ≥5% Body Weight Reduction
时间窗: Week 60
次要结局
- Percent Change from Baseline in Triglycerides(Week 60)
- Change from Baseline in Systolic Blood Pressure(Week 60)
- Percent Change from Baseline in non-high-density lipoprotein cholesteroal(Week 60)
- Proportion of Participants who Achieve ≥15% Body Weight Reduction(Week 60)
- Change from Baseline in Waist Circumference(Week 60)
- Percent Change from Baseline in low-density lipoprotein cholesterol(Week 60)
- Proportion of Participants who Achieve ≥10% Body Weight Reduction(Week 60)
- Proportion of Participants who Achieve ≥20% Body Weight Reduction(Week 60)
研究者
研究点 (1)
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