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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Placebo; Drug: Tesamorelin

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Tesamorelin 2 mg; Tesamorelin 2 mg/day	Drug: Tesamorelin
Experimental: Tesamorelin 3 mg; Tesamorelin 3 mg/day	Drug: Tesamorelin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Theratechnologies
• Investigators: Principal Investigator: Richard Casaburi, PhD, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 5, 2011
• First Posted (Estimate): July 7, 2011

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: COPD; Muscle wasting
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Nutrition Disorders; Body Weight; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Body Weight Changes; Atrophy; Emaciation; Weight Loss; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Muscular Atrophy; Wasting Syndrome; Cachexia; Physiological Effects of Drugs; Growth Substances; Tesamorelin
• Other Study ID Numbers: TH9507-CTR-1025