NCT06824051已完成1 期
A Phase 1, Double-blind, Two-arm, Mechanism of Action Study to Investigate the Effect of Orforglipron on Body Composition in Adult Participants With Obesity or Overweight, Without Diabetes
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
- 120
- 试验地点
- 4
- 主要终点
- Percent Change from Baseline in Visceral Adipose Tissue (VAT)
研究概览
简要总结
The main purpose of this study is to see how orforglipron affects the amount of body fat compared with placebo in participants with obesity or overweight. Participation in the study will last approximately 8 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a Body Mass Index (BMI)
- •≥30.0 kilograms per square meter (kg/m2), or
- •≥27.0 kg/m2 with comorbidities
排除标准
- •Have type 1 diabetes, type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
- •Have an unstable body weight within 90 days prior to screening
- •Have acute or chronic hepatitis
- •Are taking other medications or alternative remedies to manage weight loss
研究组 & 干预措施
Orforglipron
Experimental
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Placebo
Placebo Comparator
Participants will receive placebo orally
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Visceral Adipose Tissue (VAT)
时间窗: Baseline, Week 36
次要结局
- Percent Change from Baseline in Energy Intake(Baseline, Week 36)
- Percent Change from Baseline in Appetite(Baseline, Week 36)
- Percent Change from Baseline in Fasting Total Cholesterol(Baseline, Week 36)
- Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)(Baseline, Week 36)
- Change from Baseline in International Physical Activity Questionnaire-Long Form (IPAQ-L) Scores(Baseline, Week 36)
- Percent Change from Baseline in Body Weight(Baseline, Week 36)
研究者
研究点 (4)
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