NCT00092872已完成3 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 359
- 主要终点
- Safety and tolerability.
研究概览
简要总结
This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study.
排除标准
- •Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)
结局指标
主要结局
Safety and tolerability.
时间窗: After 1 year of treatment
Body weight after 1 year of treatment.
时间窗: After 1 year of treatment
次要结局
- Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years(After 2 years)
研究者
相似试验
已完成
3 期
A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)ObesityNCT00092859Merck Sharp & Dohme LLC1,500
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese ParticipantsHealthy VolunteersNCT04965402Bristol-Myers Squibb23
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese ParticipantsHealthy VolunteersNCT05813717Bristol-Myers Squibb25
终止
1 期
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis PatientsCystic FibrosisNCT02190604Novartis Pharmaceuticals153
已完成
1 期
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy SubjectsThrombosisNCT03197779Bristol-Myers Squibb691