NCT07232719进行中（未招募）3 期
A Phase 3b Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 52
- 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 evaluate the efficacy and safety of retatrutide compared with placebo for body weight reduction.
Participation in the study will last about 65 weeks and may include about 18 visits.
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) of:
- •≥30 kilogram per square meter (kg/m2) OR
- •≥27 kg/m2 with at least one of the following weight-related conditions: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease
- •Have at least one unsuccessful attempt to lose weight by dieting
排除标准
- •Have a self-reported change in body weight >5 kg (11 pounds) within 90 days before screening
- •Have a prior or planned surgical treatment for obesity
- •Have type 1 diabetes or type 2 diabetes
- •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)
- •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
- •Have taken weight loss drugs, including over-the counter medications within 90 days prior to screening
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (Drug)
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)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 56
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 56
次要结局
- Change from Baseline in Systolic Blood Pressure(Baseline, Week 56)
- Change from Baseline in Waist Circumference(Baseline, Week 56)
- Percent Change from Baseline in Non-High-Density Lipoprotein (HDL) Cholesterol(Baseline, Week 56)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)(Baseline through Week 56)
- Change from Baseline in Systolic Blood Pressure(Baseline, Week 56)
- Change from Baseline in Waist Circumference(Baseline, Week 56)
- Percent Change from Baseline in Non-High-Density Lipoprotein (HDL) Cholesterol(Baseline, Week 56)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)(Baseline through Week 56)
研究者
研究点 (52)
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