NCT05882045已完成3 期
A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,946
- 试验地点
- 323
- 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 once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 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 a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).
- •Have established cardiovascular (CV) disease with at least 1 of the following:
- •prior myocardial infarction
- •prior ischemic or hemorrhagic stroke, or
- •symptomatic peripheral arterial disease
- •Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.
排除标准
- •Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
- •Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- •Have a prior or planned surgical treatment of obesity.
- •Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
- •Have Type 1 diabetes.
- •Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •Have had pancreatitis.
研究组 & 干预措施
Retatrutide Dose 1
Experimental
Participants will receive retatrutide subcutaneously (SC).
干预措施: Retatrutide (Drug)
Retatrutide Dose 2
Experimental
Participants will receive retatrutide SC.
干预措施: Retatrutide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo.
干预措施: Placebo (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)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC)(Baseline to Week 80)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 80)
- Change from Baseline in Diastolic Blood Pressure (DBP)(Baseline, Week 80)
- Percent Change from Baseline in Fasting Insulin(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 Hemoglobin A1c (HbA1c)(Baseline, Week 80)
- Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score(Baseline, Week 80)
研究者
研究点 (323)
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