Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Tesamorelin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tesamorelin 2 mg<br>Tesamorelin 2 mg/day | Drug: Tesamorelin<br> <br> |
| Experimental: Tesamorelin 3 mg<br>Tesamorelin 3 mg/day | Drug: Tesamorelin<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Lean Body Mass at 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Exercise Capacity at 6 Months |  | 6 months | 
| Change From Baseline in Peripheral Muscle Strength at 6 Months |  | 6 months | 
| Change From Baseline in Patient-reported Outcomes at 6 Months |  | 6 months | 
| Adverse Events | Number and percentage of subjects with adverse events | 6 months | 
| COPD Exacerbations | Frequency and severity of COPD exacerbations | 6 months | 
| Plasma Glucose | Changes from baseline in fasting blood glucose | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Muscle wasting