Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
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
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
- 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
- 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]
Number and percentage of subjects with adverse events
- COPD Exacerbations [6 months]
Frequency and severity of COPD exacerbations
- Plasma Glucose [6 months]
Changes from baseline in fasting blood glucose
Eligibility Criteria
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
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.- TH9507-CTR-1025
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
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 |
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 |
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 |
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 |
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 |
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 |
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
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 |
jmamputu@theratech.com |
- TH9507-CTR-1025