CTRI/2021/09/036105已完成3 期
Efficacy and safety or tirzepatide once weekly in participants with type 2 diabetes who have obesity or are overweight: A randomised, double-blind, placebo-controlled trial (SURMOUNT-2)
Eli Lilly and Company India Pvt Ltd3 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2021年10月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 900
- 试验地点
- 3
- 主要终点
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction from Randomization
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
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
Percentage of Participants Who Achieve ≥5% Body Weight Reduction from Randomization
时间窗: Randomization, 72 Weeks | 72 Weeks
Percent Change from Randomization in Body Weight
时间窗: Randomization, 72 Weeks | 72 Weeks
次要结局
- 16.Change from Randomization in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score(Randomization, 72 Weeks)
- 1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction from Randomization(2.Percentage of Participants Who Achieve ≥15% Body Weight Reduction from Baseline)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide(Baseline through Week 72)
- 1.Change from Randomization in Absolute Body Weight(2.Change from Randomization in Body Mass Index)
研究者
研究点 (3)
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