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
Overview
- Phase
- Phase 2
- Intervention
- Tesamorelin
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- Theratechnologies
- Enrollment
- 3
- Primary Endpoint
- Change From Baseline in Lean Body Mass at 6 Months
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- Not provided
Arms & Interventions
Tesamorelin 2 mg
Tesamorelin 2 mg/day
Intervention: Tesamorelin
Tesamorelin 3 mg
Tesamorelin 3 mg/day
Intervention: Tesamorelin
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Lean Body Mass at 6 Months
Time Frame: 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
Secondary Outcomes
- 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)