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

Theratechnologies

Status and phase: Terminated; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: Tesamorelin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01388920

TH9507-CTR-1025

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 3 patient groups, including a placebo group

Tesamorelin 2 mg

Experimental group

Description:

Tesamorelin 2 mg/day

Treatment:

Drug: Tesamorelin

Tesamorelin 3 mg

Experimental group

Description:

Tesamorelin 3 mg/day

Treatment:

Drug: Tesamorelin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo