A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Doses of Tesamorelin in Stable Ambulatory COPD Subjects With Muscle Wasting
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 主要终点
- Change From Baseline in Lean Body Mass at 6 Months
研究概览
简要总结
A significant proportion of COPD subjects experience muscle wasting, which has been associated with increased morbidity, impaired physical functioning, and a poor quality of life.
Muscle wasting is associated with reduced muscle strength in COPD subjects. In particular, weakness of peripheral muscles has been reported to play an important role in the reduced functional capacity and impaired exercise performance.
The primary objective of this study is to investigate the effect of tesamorelin, in conjunction with exercise training, on lean body mass measured by dual energy x-ray absorptiometry (DXA) scan.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 40-75 years (y) inclusive
- •Documented diagnosis of moderate to very severe COPD (GOLD stage 2, 3, or 4)
- •Stable COPD (i.e., no exacerbation) for at least 6 weeks prior to screening
- •Able to participate in a supervised exercise training program
- •Evidence of muscle wasting
- •Exclusion Criteria
- •Participation in a pulmonary rehabilitation program or in any supervised exercise program during the 4 months prior to screening
- •More than 4 exacerbations in the year prior to screening
- •Life-threatening exacerbation in the year prior to screening
- •Requirement for long-term oxygen therapy (> 12 hours of oxygen per day)
- •Critical illness or co-morbid conditions that may interfere with study conduct or endpoint measurements
- •Use of agents known to increase lean body mass within 3 months prior to screening
- •Hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma
排除标准
- 未提供
研究组 & 干预措施
Tesamorelin 2 mg
Tesamorelin 2 mg/day
干预措施: Tesamorelin (Drug)
Tesamorelin 3 mg
Tesamorelin 3 mg/day
干预措施: Tesamorelin (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Lean Body Mass at 6 Months
时间窗: 6 months
The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan
次要结局
- Change From Baseline in Patient-reported Outcomes at 6 Months(6 months)
- Plasma Glucose(6 months)
- Change From Baseline in Exercise Capacity at 6 Months(6 months)
- Change From Baseline in Peripheral Muscle Strength at 6 Months(6 months)
- Adverse Events(6 months)
- COPD Exacerbations(6 months)