NCT07845500尚未招募3 期
A PHASE 3 STUDY TO EVALUATE THE SWITCH TO MONTHLY BEROBENATIDE FOR MAINTAINING WEIGHT IN ADULTS WHO ARE ON WEEKLY SEMAGLUTIDE OR TIRZEPATIDE (VESPER-SWITCH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 660
- 试验地点
- 8
- 主要终点
- Percent change from baseline in body weight
研究概览
简要总结
The purpose of this study is to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide. The study does not include people with diabetes.
Participants will be in the study for about 11 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
- None
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
- •Aged ≥18 years.
- •Currently taking semaglutide or tirzepatide for obesity management.
排除标准
- •Diagnosis of any form of diabetes.
- •History of acute or chronic pancreatitis.
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
研究组 & 干预措施
Experimental
Experimental
Participants will receive Berobenatide by Subcutaneous Injection.
干预措施: Berobenatide (Drug)
Active Comparator
Active Comparator
Participants will receive Semaglutide or Tirzepatide by Subcutaneous Injection.
干预措施: Tirzepatide (Drug)
Active Comparator
Active Comparator
Participants will receive Semaglutide or Tirzepatide by Subcutaneous Injection.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Percent change from baseline in body weight
时间窗: Baseline, Week 32
次要结局
- Change from baseline in body weight(Baseline, Week 32)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Baseline, Week 32)
- Number of Participants with Serious adverse events (SAEs)(Baseline, Week 32)
- Number of Participants with adverse events leading to discontinuation(Baseline, Week 32)
- Number of Participants with Adverse Events of Special Interest (AESIs)(Baseline, Week 32)
- Number of Participants with Clinical Laboratory Abnormalities(Baseline, Week 32)
研究者
研究点 (8)
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