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

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