NCT04657003已完成3 期
Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)
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
- 938
- 试验地点
- 75
- 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 type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 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 Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
- •Have a BMI of ≥27 kg/m²
- •Are overweight or have obesity
- •Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
- •Are at least 18 years of age and age of majority per local laws and regulations
排除标准
- •Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
- •Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
- •Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
- •Have self-reported change in body weight >5kg within 3 months prior to screening
- •Have had a history of chronic or acute pancreatitis
- •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
- •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
10 milligrams (mg) Tirzepatide
Experimental
10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW)
干预措施: Tirzepatide (Drug)
15 mg Tirzepatide
Experimental
15 mg Tirzepatide administered SC QW
干预措施: Tirzepatide (Drug)
Placebo
Placebo Comparator
Placebo administered SC 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, Week 72
Least Squares Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline
时间窗: Week 72
Percentage of participants who achieve ≥5% body weight reduction from baseline
次要结局
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline(Week 72)
- Change From Baseline in Fasting Glucose(Baseline, Week 72)
- Change From Baseline in Waist Circumference(Baseline, Week 72)
- Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 72)
- Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 72)
- Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 72)
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline(Week 72)
- Change From Baseline in Absolute Body Weight(Baseline, Week 72)
- Percentage of Participants Who Achieve HbA1c ≤6.5%(Week 72)
- Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)(Baseline, Week 72)
- Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score(Baseline, Week 72)
- Change From Baseline in Body Mass Index (BMI)(Baseline, Week 72)
- Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 72)
- Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline(Week 72)
- Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 72)
- Percentage of Participants Who Achieve HbA1c <7%(Week 72)
- Percentage of Participants Who Achieve HbA1c <5.7%(Week 72)
- Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 72)
- Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)(Baseline, Week 72)
- Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide)(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)
- Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)(Baseline, Week 72)
- Percent Change From Baseline in Fasting Insulin(Baseline, Week 72)
- Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide(Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose)
研究者
研究点 (75)
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