jRCT2051250032尚未招募不适用
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 J2A-MC-GZP1:Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity (excluding type 2 diabetes) (J2A-MC-GZP1)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Have body mass index (BMI) >=30 kilograms per square meter (kg/m2) or BMI >=25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:
- •hypertension
- •dyslipidemia
- •obstructive sleep apnea, or
- •cardiovascular disease
- •Have a history of at least one unsuccessful dietary effort to lose body weight
排除标准
- •Have type 1 diabetes, type 2 diabetes, or any other types of diabetes
- •Have an unstable body weight within 90 days prior to screening
- •Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening
- •Have acute or chronic hepatitis or pancreatitis
- •Are taking other medications or alternative remedies to manage weight loss
结局指标
主要结局
-
Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40
次要结局
未报告次要终点
研究者
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