A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients With Sarcopenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 主要终点
- Change From Baseline in Bilateral Leg Press (BLP) Measurement
研究概览
简要总结
A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with sarcopenia (loss of muscle mass).
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is a woman who is 65 years of age or older
- •Patient's lean body mass is at least 1 standard deviation below the mean of a healthy young adult population
- •Patient has difficulty climbing 10 steps or walking outside on level ground for 1/4 mile without resting or Activity Measure for Post Acute Care (AM-PAC)<66
排除标准
- •Patient has serious neurological, rheumatologic, cardiac, respiratory, kidney, psychiatric conditions
- •Patient has a history of certain types of cancer
结局指标
主要结局
Change From Baseline in Bilateral Leg Press (BLP) Measurement
时间窗: Baseline, Month 6
BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.
Change From Baseline in Participant Lean Body Mass
时间窗: Baseline, Month 6
次要结局
- Change From Baseline in Stair Climbing Power(Baseline, Month 6)
- Change From Baseline in Participant Gait Speed(Baseline, Month 6)
- Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score(Baseline, Month 6)
- Change From Baseline in Participant Short Physical Performance Battery (SPPB)(Baseline, Month 6)