NCT06047548进行中（未招募）3 期
A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Once Weekly 5 mg and/or Maximum Tolerated Dose Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-MAINTAIN)
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
- 400
- 试验地点
- 20
- 主要终点
- Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.
详细描述
All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.
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/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:
- •Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- •Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)
排除标准
- •Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma.
- •Have a self-reported change in BW>5 kilogram (kg) within 3 months prior to screening
- •Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed >1 year prior to screening.
- •Have a history of chronic or acute pancreatitis
- •Have any of the following cardiovascular conditions within 3 months prior to week
- •Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF)
- •family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
- •Any lifetime history of a suicide attempt
研究组 & 干预措施
Tirzepatide 5 milligram (mg)
Experimental
Participants will receive tirzepatide subcutaneously (SC).
干预措施: Tirzepatide (Drug)
Tirzepatide Maximum Tolerated Dose
Experimental
Participants will receive tirzepatide SC.
干预措施: Tirzepatide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period
时间窗: Week 112
Mean percent maintenance of BW reduction achieved during the 60-Week weight loss period will be measured in participants who have reached a BW plateau.
次要结局
- Percent Change from Baseline in Body Weight(Baseline (Week 0), Week 112)
- Change from Randomization in Body Weight(Week 60, Week 112)
- Percent Change from Randomization in Body Weight(Week 60, Week 112)
- Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period(Week 84)
- Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period(Week 112)
- Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization(Week 112)
- Change from Randomization in Waist Circumference(Week 60, Week 112)
研究者
研究点 (20)
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