A Phase 2b, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and Without Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 40
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •See Master Protocol CWMM (NCT06143956) for inclusion criteria
排除标准
- •In addition to exclusion criteria in Master Protocol CWMM (NCT06143956):
- •Have type 1 diabetes or type 2 diabetes
- •Have an ongoing history of bradyarrhythmia and/or sinus bradycardia
- •Have an elevated resting pulse rate (greater than 100 bpm) or reduced resting pulse rate (less than 60 bpm)
- •Have a history of acute or chronic pancreatitis
- •All concomitant medications should be at a stable dose for at least 3 months prior to screening
研究组 & 干预措施
Eloralintide Dose 2
Participants will receive eloralintide SC
干预措施: Eloralintide (Drug)
Placebo
Participants will receive placebo SC
干预措施: Placebo (Drug)
Macupatide Dose 1 + Eloralintide Dose 2
Participants will receive macupatide SC and eloralintide SC
干预措施: Eloralintide (Drug)
Macupatide Dose 2 + Eloralintide Dose 3
Participants will receive macupatide SC and eloralintide SC
干预措施: Macupatide (Drug)
Eloralintide Dose 3
Participants will receive eloralintide SC
干预措施: Eloralintide (Drug)
Macupatide Dose 2 + Eloralintide Dose 3
Participants will receive macupatide SC and eloralintide SC
干预措施: Eloralintide (Drug)
Eloralintide Dose 1
Participants will receive eloralintide SC
干预措施: Eloralintide (Drug)
Macupatide Dose 1 + Eloralintide Dose 1
Participants will receive macupatide SC and eloralintide SC
干预措施: Macupatide (Drug)
Macupatide Dose 1 + Eloralintide Dose 2
Participants will receive macupatide SC and eloralintide SC
干预措施: Macupatide (Drug)
Macupatide Dose 1 + Eloralintide Dose 1
Participants will receive macupatide SC and eloralintide SC
干预措施: Eloralintide (Drug)
Macupatide Dose 1
Participants will receive macupatide subcutaneously (SC)
干预措施: Macupatide (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 36
次要结局
- Percent Change from Baseline in Body Weight(Baseline, Week 48)
- Change from Baseline in Body Weight(Baseline, Week 36)
- Percentage of Participants who Achieve ≥5% Body Weight Reduction(Week 36)
- Percentage of Participants who Achieve ≥10% Body Weight Reduction(Week 36)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 36)