NCT06972459进行中（未招募）3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 151
- 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 is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792).
Participation in the study will last about 18 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
- 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 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
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo orally
干预措施: Placebo (Drug)
Orforglipron Dose 2
Experimental
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron Dose 3
Experimental
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron Dose 1
Experimental
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron Dose 4
Experimental
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 72
次要结局
- Percentage of Participants Achieving Weight Reduction of ≥5%(Baseline up to 72 weeks)
- Change from Baseline in Waist Circumference(Baseline up to 72 weeks)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline up to 72 weeks)
- Percent Change from Baseline in Triglycerides(Baseline up to 72 weeks)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline up to 72 weeks)
- Change from Baseline in EQ-5D-5L(Baseline, Week 72)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron(Predose through Week 48)
- Percentage of Participants Achieving Weight Reduction of ≥5%(Baseline up to 72 weeks)
- Change from Baseline in Waist Circumference(Baseline up to 72 weeks)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 72)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline up to 72 weeks)
- Percent Change from Baseline in Triglycerides(Baseline up to 72 weeks)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline up to 72 weeks)
- Change from Baseline in Fasting Glucose(Baseline up to 72 weeks)
- Change from Baseline in EQ-5D-5L(Baseline, Week 72)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron(Predose through Week 48)
研究者
研究点 (151)
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