A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Retatrutide Treatment in the Maintenance of Weight Reduction in Individuals With Obesity
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 643
- 试验地点
- 53
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight
排除标准
- •Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days before screening
- •Have a prior or planned surgical treatment for obesity
- •Have a prior or planned endoscopic procedure and/or device-based therapy for obesity
- •Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •Have had within the past 90 days before screening:
- •acute myocardial infarction
- •cerebrovascular accident (stroke)
- •hospitalization for unstable angina, or
- •hospitalization due to congestive heart failure
- •Have New York Heart Association Functional Classification Class IV congestive heart failure
- •Have a history of chronic or acute pancreatitis
- •Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
研究组 & 干预措施
Retatrutide Dose 1 to Retatrutide Dose 2
Participants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks
干预措施: Retatrutide (Drug)
Retatrutide Dose 1 to Placebo
Participants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks
干预措施: Retatrutide (Drug)
Retatrutide Dose 1
Participants will receive retatrutide dose 1 administered subcutaneously (SC) for 116 weeks
干预措施: Retatrutide (Drug)
Retatrutide Dose 1 to Placebo
Participants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Week 0, Week 116
次要结局
- Change from Baseline in Waist Circumference(Week 0, Week 116)
- Percentage of Body Weight Reduction Achieved at Week 80 that is Maintained at Week 116(Week 0, Week 80, Week 116)
- Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)(Week 0, Week 116)