CTRI/2020/04/024660已完成3 期
Efficacy and Safety of Tirzepatide Once Weekly in Participants without Type 2 Diabetes Who Have Obesity or are Overweight with Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)
Eli Lilly and Company India Pvt Ltd10 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2020年5月15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
- 2,400
- 试验地点
- 10
- 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 overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks (14 visits). Participants with prediabetes will continue in the extension for another 2 years.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, 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.
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 72 | Week 72
Percentage of Participants who Achieve ≥5% Body Weight Reduction
时间窗: Baseline, Week 72 | Week 72
次要结局
- Change from Baseline in Body Weight(Baseline, Week 20)
- Percent Change from Baseline in Body Weight(Baseline, Week 176)
- Percentage of Participants who Achieve ≥10% Body Weight Reduction(Percentage of Participants who Achieve ≥15% Body Weight Reduction)
- Percentage of Participants who Achieve ≥5% Body Weight Reduction(Week 176)
- Change from Baseline in Waist Circumference(Change from Baseline in Body Mass Index (BMI))
- Time to Onset of Type 2 Diabetes(Baseline through Week 176)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Change from Baseline in Triglycerides)
- Change from Baseline in Diastolic Blood Pressure(Change from Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide(Baseline through Week 72)
研究者
研究点 (10)
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