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

Sponsor
Theratechnologies (Industry)
Overall Status
Terminated
CT.gov ID
NCT01388920
Collaborator
(none)
3
3
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tesamorelin 2 mg

Tesamorelin 2 mg/day

Drug: Tesamorelin

Experimental: Tesamorelin 3 mg

Tesamorelin 3 mg/day

Drug: Tesamorelin

Placebo Comparator: Placebo

Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in Lean Body Mass at 6 Months [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

Secondary Outcome Measures

  1. Change From Baseline in Exercise Capacity at 6 Months [6 months]

  2. Change From Baseline in Peripheral Muscle Strength at 6 Months [6 months]

  3. Change From Baseline in Patient-reported Outcomes at 6 Months [6 months]

  4. Adverse Events [6 months]

    Number and percentage of subjects with adverse events

  5. COPD Exacerbations [6 months]

    Frequency and severity of COPD exacerbations

  6. Plasma Glucose [6 months]

    Changes from baseline in fasting blood glucose

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Theratechnologies

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Theratechnologies
ClinicalTrials.gov Identifier:
NCT01388920
Other Study ID Numbers:
  • TH9507-CTR-1025
First Posted:
Jul 7, 2011
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Tesamorelin 2 mg Tesamorelin 3 mg Placebo
Arm/Group Description Tesamorelin 2 mg/day for 6 months Tesamorelin 3 mg/day for 6 months Placebo for 6 monts
Period Title: Overall Study
STARTED 1 1 0
COMPLETED 1 1 0
NOT COMPLETED 0 0 0

Baseline Characteristics

Arm/Group Title Tesamorelin 2 mg Tesamorelin 3 mg Placebo Total
Arm/Group Description Tesamorelin 2 mg/day for 6 months Tesamorelin 3 mg/day for 6 months Placebo for 6 months Total of all reporting groups
Overall Participants 1 1 0 2
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
59
(0)
51
(0)
55
(0)
Sex: Female, Male (Count of Participants)
Female
0
0%
1
100%
1
Infinity
Male
1
100%
0
0%
1
Infinity
Region of Enrollment (participants) [Number]
United States
1
100%
1
100%
2
Infinity

Outcome Measures

1. Primary Outcome
Title Change From Baseline in Lean Body Mass at 6 Months
Description 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
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
The primary objective of the study was the change in lean body mass between baseline and Month 6. However, the study was halted approximately 1 month after patient enrollment.
Arm/Group Title Tesamorelin 2 mg Tesamorelin 3 mg Placebo
Arm/Group Description Tesamorelin 2 mg/day for 6 months Tesamorelin 3 mg/day for 6 months Placebo for 6 months
Measure Participants 0 0 0
2. Secondary Outcome
Title Change From Baseline in Exercise Capacity at 6 Months
Description
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
3. Secondary Outcome
Title Change From Baseline in Peripheral Muscle Strength at 6 Months
Description
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
4. Secondary Outcome
Title Change From Baseline in Patient-reported Outcomes at 6 Months
Description
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
5. Secondary Outcome
Title Adverse Events
Description Number and percentage of subjects with adverse events
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
6. Secondary Outcome
Title COPD Exacerbations
Description Frequency and severity of COPD exacerbations
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
7. Secondary Outcome
Title Plasma Glucose
Description Changes from baseline in fasting blood glucose
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Tesamorelin 2 mg Tesamorelin 3 mg Placebo
Arm/Group Description Tesamorelin 2 mg/day for 6 months Tesamorelin 3 mg/day for 6 months Placebo for 6 months
All Cause Mortality
Tesamorelin 2 mg Tesamorelin 3 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Tesamorelin 2 mg Tesamorelin 3 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/1 (0%) 0/1 (0%) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Tesamorelin 2 mg Tesamorelin 3 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/1 (0%) 0/1 (0%) 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Senior Medical Advisor
Organization Theratechnologies
Phone 514-336-7800
Email jmamputu@theratech.com
Responsible Party:
Theratechnologies
ClinicalTrials.gov Identifier:
NCT01388920
Other Study ID Numbers:
  • TH9507-CTR-1025
First Posted:
Jul 7, 2011
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022