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The study was terminated based on a non-safety related corporate decision.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tesamorelin 2 mg | Experimental | Tesamorelin 2 mg/day |
|
| Tesamorelin 3 mg | Experimental | Tesamorelin 3 mg/day |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesamorelin | Drug |
| ||
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Richard Casaburi, PhD, MD | University of California, Los Angeles | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tesamorelin 2 mg | Tesamorelin 2 mg/day for 6 months |
| FG001 | Tesamorelin 3 mg | Tesamorelin 3 mg/day for 6 months |
| FG002 | Placebo | Placebo for 6 monts |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tesamorelin 2 mg | Tesamorelin 2 mg/day for 6 months |
| BG001 | Tesamorelin 3 mg | Tesamorelin 3 mg/day for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tesamorelin 2 mg | Tesamorelin 2 mg/day for 6 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Advisor | Theratechnologies | 514-336-7800 | jmamputu@theratech.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C479538 | tesamorelin |
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| Drug |
|
| 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 |
| BG002 |
| Placebo |
Placebo for 6 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo for 6 months |
|
| Secondary | Change From Baseline in Exercise Capacity at 6 Months | Not Posted | 6 months | Participants |
| Secondary | Change From Baseline in Peripheral Muscle Strength at 6 Months | Not Posted | 6 months | Participants |
| Secondary | Change From Baseline in Patient-reported Outcomes at 6 Months | Not Posted | 6 months | Participants |
| Secondary | Adverse Events | Number and percentage of subjects with adverse events | Not Posted | 6 months | Participants |
| Secondary | COPD Exacerbations | Frequency and severity of COPD exacerbations | Not Posted | 6 months | Participants |
| Secondary | Plasma Glucose | Changes from baseline in fasting blood glucose | Not Posted | 6 months | Participants |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Tesamorelin 3 mg | Tesamorelin 3 mg/day for 6 months | 0 | 1 | 0 | 1 |
| EG002 | Placebo | Placebo for 6 months | 0 | 0 | 0 | 0 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |