Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 18
- 主要终点
- Mean Percent Change in Body Weight
研究概览
简要总结
The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a BMI of greater than or equal to ≥27 kg/m² and <less than 35 kg/m² with at least 2 obesity-related health problems or ≥35 kg/m² with at least 1 obesity-related health problems. Health problems are IGT, hyperlipidemia, or NAFLD.
- •Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
排除标准
- •Have diabetes.
- •Acute or chronic liver disease other than NAFLD.
- •Have a self-reported change in body weight >5 kg within 3 months prior to screening.
- •Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months.
- •Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, calculated by Japanese Society of Nephrology coefficient-modified Chronic Kidney Disease-Epidemiology equation during screening.
- •Have a known clinically significant gastric emptying abnormality.
- •Have had a history of chronic or acute pancreatitis.
- •Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (μIU/mL) at screening.
- •Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
- •Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.
- •Have a cardiovascular condition within 3 months prior to randomization
- •Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.
研究组 & 干预措施
Placebo
Participants received matching placebo administered SC QW.
干预措施: Placebo (Other)
15 mg Tirzepatide
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
干预措施: Tirzepatide (Drug)
10 Milligrams (mg) Tirzepatide
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Mean Percent Change in Body Weight
时间窗: Baseline, 72 Weeks
Mean percent change in body weight was measured. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + impaired glucose tolerance (IGT) at Screening + Hyperlipidemia at Screening + non-alcoholic fatty liver disease (NAFLD) at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
时间窗: Week 72
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
次要结局
- Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD](Baseline, Week 72)
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Week 72)
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction(Week 72)
- Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 72)
- Change From Baseline in Fasting Insulin for Participants With IGT at Baseline(Baseline, Week 72)
- Change From Baseline in Fasting Glucose for Participants With IGT at Baseline(Baseline, Week 72)
- Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline(Baseline, Week 72)
- Percentage of Participants Who Had Improvement in Obesity-related Health Problems(Week 72)
- Percentage of Participants Who Achieved Improvements of IGT(Week 72)
- Change From Baseline in VAT/SAT Ratio(Baseline, Week 72)
- Change From Baseline in Systolic Blood Pressure(Baseline, Week 72)
- Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline(Baseline, Week 72)
- Percentage of Participants Who Achieved Improvements of Hyperlipidemia(Week 72)
- Percentage of Participants Who Achieved Improvements of NAFLD(Week 72)
- Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)(Baseline, Week 72)
- Change From Baseline in Diastolic Blood Pressure(Baseline, Week 72)
- Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline(Week 72)
- Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)(Baseline, Week 72)
- Change From Baseline in Waist Circumference(Baseline, Week 72)
- Change From Baseline in Absolute Body Weight(Baseline, Week 72)
- Change From Baseline in Body Mass Index (BMI)(Baseline, Week 72)
- Percent Change From Baseline in Visceral Adipose Tissue (VAT)(Baseline, Week 72)
- Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score(Baseline, Week 72)
- Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score(Baseline, Week 72)