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

NCT01388920 | Terminated Phase 2 Results

• 1 other identifier: TH9507-CTR-1025
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Muscle wasting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  6 months

• COPD Exacerbations

  6 months

Study Arms (3)

Tesamorelin 2 mg

EXPERIMENTAL

Tesamorelin 2 mg/day

Drug: Tesamorelin

Tesamorelin 3 mg

EXPERIMENTAL

Tesamorelin 3 mg/day

Drug: Tesamorelin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Tesamorelin DRUG

Tesamorelin 2 mg; Tesamorelin 3 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theratechnologies: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Muscular Atrophy

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Results Point of Contact

• Title: Senior Medical Advisor
• Organization: Theratechnologies

jmamputu@theratech.com

514-336-7800

Study Officials

• Richard Casaburi, PhD, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 7, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 18, 2022
• Results First Posted: May 7, 2014

Record last verified: 2022-03