NCT04660643已完成3 期
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)
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
- 783
- 试验地点
- 70
- 主要终点
- Percent Change From Randomization in Body Weight at Week 88
研究概览
简要总结
This was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 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
- •Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- •History of at least one unsuccessful dietary effort to lose body weight
排除标准
- •Diabetes mellitus
- •Change in body weight greater than 5 kg within 3 months prior to starting study
- •Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
- •History of pancreatitis
- •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 (lead-in)
Experimental
Participants received weekly doses of tirzepatide subcutaneously (SC) for 36 weeks, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks, as tolerated, up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
干预措施: Tirzepatide (Drug)
Tirzepatide MTD
Experimental
Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks.
干预措施: Tirzepatide (Drug)
Placebo
Placebo Comparator
Participants received weekly doses of placebo SC for 52 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Percent Change From Randomization in Body Weight at Week 88
时间窗: Randomization (Week 36), Week 88
Least square (LS) mean was analysed by mixed model repeated measures (MMRM) model with randomization + analysis country + sex + interactive web response system (IWRS) MTD at Week 36 + treatment + time + treatment\*time (Type III sum of squares) as variables.
次要结局
- Change From Randomization in Hemoglobin A1c (HbA1c)(Randomization (Week 36), Week 88)
- Percent Change From Randomization in Lipid Parameters (Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Very Low Density Lipoprotein (VLDL) Cholesterol, Triglycerides, Free Fatty Acids (FFA))(Randomization (Week 36), Week 88)
- Percent Change From Baseline in Body Weight(Baseline (Week 0), Week 88)
- Percent Change From Baseline in Lipid Parameters (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides, FFAs)(Baseline (Week 0), Week 88)
- Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline(Baseline (Week 0) to Week 88)
- Change From Baseline in Body Weight(Baseline (Week 0), Week 88)
- Change From Baseline in Waist Circumference(Baseline (Week 0), Week 88)
- Change From Baseline in Fasting Glucose(Baseline (Week 0), Week 88)
- Change From Baseline in HbA1c(Baseline (Week 0), Week 88)
- Percent Change From Baseline in Fasting Insulin(Baseline (Week 0), Week 88)
- Percent Change From Randomization in Body Weight at Week 64(Randomization (Week 36), Week 64)
- Change From Randomization in Body Mass Index (BMI)(Randomization (Week 36), Week 88)
- Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period(Randomization (Week 36) to Week 88)
- Change From Randomization in Body Weight(Randomization (Week 36), Week 88)
- Change From Randomization in Waist Circumference(Randomization (Week 36), Week 88)
- Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP)(Randomization (Week 36), Week 88)
- Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score(Randomization (Week 36), Week 88)
- Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period(Week 88)
- Change From Randomization in Fasting Glucose(Randomization (Week 36), Week 88)
- Percent Change From Randomization in Fasting Insulin(Randomization (Week 36), Week 88)
- Change From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score(Randomization (Week 36), Week 88)
- Change From Baseline in BMI(Baseline (Week 0), Week 88)
- Change From Baseline in SBP, DBP(Baseline (Week 0), Week 88)
- Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score(Baseline (Week 0), Week 88)
- Change From Baseline in SF 36v2 Acute Form - Physical Functioning Domain Score(Baseline (Week 0), Week 88)
研究者
研究点 (70)
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