A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
- 试验地点
- 139
- 主要终点
- Number of Participants Allocated to Each Study
研究概览
简要总结
The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •There are no specific eligibility criteria for the Master Protocol.
- •See study GZP1 for eligibility criteria relevant to participants with obesity and overweight without type 2 diabetes
- •See study GZP2 for eligibility criteria relevant to participants with type 2 diabetes
排除标准
- 未提供
研究组 & 干预措施
Orforglipron Dose 3 (Study GZP1)
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Placebo (Study GZP2)
Participants will receive placebo orally
干预措施: Placebo (Drug)
Placebo (Study GZP1)
Participants will receive placebo orally
干预措施: Placebo (Drug)
Orforglipron Dose 1 (Study GZP1)
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron Dose 2 (Study GZP1)
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron Dose 4 (Study GZP1)
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron Dose 1 (Study GZP2)
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron Dose 2 (Study GZP2)
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron Dose 3 (Study GZP2)
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron Dose 4 (Study GZP2)
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
结局指标
主要结局
Number of Participants Allocated to Each Study
时间窗: Baseline to Week 4
次要结局
未报告次要终点