NCT06662383进行中（未招募）3 期
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity
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
- 122
- 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 evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight.
排除标准
- •Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days before screening.
- •Have a prior or planned surgical treatment for obesity.
- •Have a prior or planned endoscopic procedure and/or device-based therapy for obesity.
- •Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
- •Have had within the past 90 days before screening:
- •acute myocardial infarction
- •cerebrovascular accident (stroke)
- •coronary revascularization
- •hospitalization for unstable angina, or
- •hospitalization due to congestive heart failure.
- •Have New York Heart Association Functional Classification Class IV congestive heart failure.
- •Have a history of chronic or acute pancreatitis.
研究组 & 干预措施
Retatrutide
Experimental
Participants will receive retatrutide administered subcutaneously (SC)
干预措施: Retatrutide (Drug)
Tirzepatide
Active Comparator
Participants will receive tirzepatide administered SC
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 80
次要结局
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 80)
- Change from Baseline in Waist Circumference(Baseline, Week 80)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 80)
- Percent Change from Baseline in Triglycerides(Baseline, Week 80)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 80)
- Change from Baseline in Diastolic Blood Pressure (DBP)(Baseline, Week 80)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 80)
- Percent Change from Baseline in Fasting Insulin(Baseline, Week 80)
- Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)(Baseline, Week 80)
研究者
研究点 (122)
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