A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Orforglipron Once Daily Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 58
- 主要终点
- Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction in participants who previously completed treatment with injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy) in the SURMOUNT-5 trial (NCT05822830).
详细描述
All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. SURMOUNT-5 randomized participants to either injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy); therefore, all ATTAIN-MAINTAIN participants had prior exposure to one of these injectable incretin-based therapies before transitioning directly to orforglipron 12 mg capsule or placebo. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.
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 completed the SURMOUNT-5 study (NCT05822830; a trial of injectable tirzepatide [Zepbound] versus injectable semaglutide [Wegovy]) on study treatment
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 a prior or planned surgical treatment for obesity
- •Have acute or chronic hepatitis
- •Have a history of acute or chronic pancreatitis
研究组 & 干预措施
Placebo
Participants will receive placebo orally
干预措施: Placebo (Drug)
Orforglipron
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
结局指标
主要结局
Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
时间窗: Week 52
次要结局
- Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment(Week 52)
- Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5(Week 52)
- Change from Baseline in Body Weight(Baseline, Week 52)
- Change from Baseline in Waist Circumference(Baseline, Week 52)
- Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5(Week 24)