NCT05607680已完成3 期
A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of IBI362 in Chinese Participants With Obesity or Overweight (GLORY-1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 610
- 试验地点
- 23
- 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 III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-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
- Triple (Participant, Care Provider, Investigator)
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
- •Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea.
排除标准
- •5% at screening or previous diagnosis of type 1 or type 2 diabetes;
- •Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening;
- •Have used or are currently using weight loss drugs within 3 months before screening;
- •History of pancreatitis;
- •Family or personal history of thyroid C-cell carcinoma or multiple endocrine neoplasia (MEN) 2A or 2B；
- •History of moderate to severe depression or severe mental illness;
- •Any lifetime history of a suicide attempt
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo,SC,once a week for 48 weeks
干预措施: Placebo (Drug)
IBI362 4 mg
Experimental
2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks
干预措施: IBI362 (Drug)
IBI362 6 mg
Experimental
2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 4 weeks 6 mg,SC,once a week for 40 weeks
干预措施: IBI362 (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 32
Percentage of Participants who Achieve ≥5% Body Weight Reduction
时间窗: Week 32
次要结局
- Percentage of Participants who Achieve ≥10%Body Weight Reduction(Week 32,Week 48)
- Percentage of Participants who Achieve ≥15% Body Weight Reduction(Week 32,Week 48)
- Change from Baseline in Waist Circumference(Baseline, Week 32,Week 48)
- Percent Change from Baseline in Body Weight(Baseline, Week 60)
- Percentage of Participants who Achieve ≥5% Body Weight Reduction(Week 48)
- Percentage of Participants who Achieve ≥20% Body Weight Reduction(Week 32, Week 48)
- Change from Baseline in Neck Circumference(Baseline, Week 32, Week 48)
- Change from Baseline in Hip Circumference(Baseline, Week 32, Week 48)
- Change from Baseline in Body Weight(Baseline, Week 32, Week 48)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 32, Week 48)
- Percentage of Participants with BMI < 24 kg/m2(Week 32, Week 48)
- Change from Baseline in Systolic Blood Pressure(Baseline, Week 32, Week 48)
- Change from Baseline in Diastolic Blood Pressure(Baseline, Week 32, Week 48)
- Change from Baseline in Triglyceride(Baseline, Week 32,Week 48)
- Change from Baseline in Total Cholesterol(Baseline, Week 32, Week 48)
- Change from Baseline in Low-density Lipoprotein Cholesterol(Baseline, Week 32, Week 48)
- Change from Baseline in High-density Lipoprotein Cholesterol(Baseline, Week 32, Week 48)
- Change from Baseline in Serum Uric Acid(Baseline, Week 32, Week 48)
- Change from Baseline in Alanine Aminotransferase(Baseline, Week 32, Week 48)
- Change from Baseline in Aspartate Aminotransferase(Baseline, Week 32, Week 48)
- Change from Baseline in Glycated Hemoglobin A1c (HbA1c)(Baseline, Week 32, Week 48)
- Change from Baseline in Fasting Plasma Glucose(Baseline, Week 32, Week 48)
- Change from Baseline in Fasting Insulin(Baseline, Week 32, Week 48)
- Change from Baseline in Fasting C-peptide(Baseline, Week 32, Week 48)
- Change from Baseline in Homeostatic Model Assessment of Insulin Resistance-Insulin Resistance Index (HOMA2-IR)(Baseline, Week 32, Week 48)
- Change from Baseline in IWQoL-Lite-CT Questionnaire Scores(Baseline, Week 32, Week 48)
- Change from Baseline in SF-36v2 Questionnaire Scores(Baseline, Week 32, Week 48)
研究者
研究点 (23)
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