Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 579
- 试验地点
- 62
- 主要终点
- Percent Change From Baseline in Body Weight
研究概览
简要总结
This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 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) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or 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
Participants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
干预措施: Tirzepatide (Drug)
Placebo
Participants received matching placebo SC once weekly (QW).
干预措施: Placebo (Other)
结局指标
主要结局
Percent Change From Baseline in Body Weight
时间窗: Baseline, 72 Weeks
Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction
时间窗: Week 72
Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.
次要结局
- Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program(72 Weeks)
- Change From Baseline in Waist Circumference(Baseline, 72 Weeks)
- Percentage of Participants Who Achieve ≥10%Body Weight Reduction(72 Weeks)
- Change From Baseline in Body Mass Index (BMI)(Baseline, 72 Weeks)
- Change From Baseline in Systolic Blood Pressure (SBP)(Baseline, 72 Weeks)
- Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol(Baseline, 72 Weeks)
- Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol(Baseline, 72 Weeks)
- Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol(Baseline, 72 Weeks)
- Change From Baseline in Fasting Glucose(Baseline, 72 Weeks)
- Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline, 72 Weeks)
- Percent Change From Baseline in Fasting Insulin(Baseline, 72 Weeks)
- Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (SF 36v2) Acute Form Physical Functioning Domain Score(Baseline, 72 Weeks)
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction(72 Weeks)
- Percentage of Participants Who Achieve ≥20% Body Weight Reduction(72 Weeks)
- Change From Baseline in Body Weight(Baseline, 72 Weeks)
- Change From Baseline in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score(Baseline, 72 Weeks)
- Change From Baseline in Diastolic Blood Pressure (DBP)(Baseline, 72 Weeks)
- Percent Change From Baseline in Total Cholesterol(Baseline, 72 Weeks)
- Percent Change From Baseline in Triglycerides(Baseline, 72 Weeks)
- Percent Change From Baseline in Free Fatty Acids(Baseline, 72 Weeks)