Efficacy and Safety of Tirzepatide Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-CN)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 29
- 主要终点
- Mean Percent Change From Baseline in Body Weight
研究概览
简要总结
This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight.
The main purpose is to learn more about how tirzepatide affects body weight.
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 BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- •Have a history of at least one self-reported unsuccessful dietary effort to lose body weight
排除标准
- •Have Diabetes Mellitus
- •Have a self-reported change in body weight >5 kg within 3 months prior to screening
- •Have obesity induced by other endocrinological disorders
- •Have had a history of chronic or acute pancreatitis
- •Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years
- •Have any lifetime history of a suicide attempt
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
研究组 & 干预措施
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)
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)
Placebo
Participants received matching placebo SC QW.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Percent Change From Baseline in Body Weight
时间窗: Baseline, Week 52
Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
时间窗: Week 52
Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis.
次要结局
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Week 52)
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction(Week 52)
- Mean Change From Baseline in Body Weight(Baseline, Week 20)
- Mean Change From Baseline in Absolute Body Weight(Baseline, Week 52)
- Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 52)
- Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 52)
- Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 52)
- Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 52)
- Mean Change From Baseline in Waist Circumference(Baseline, Week 52)
- Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score(Baseline, Week 52)
- Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score(Baseline, Week 52)
- Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 52)
- Mean Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 52)
- Mean Change From Baseline in Fasting Glucose (FSG)(Baseline, Week 52)
- Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 52)
- Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 52)
- Mean Change From Baseline in Body Mass Index (BMI)(Baseline, Week 52)
- Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 52)
- Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 52)