Trial · NCT01388920
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
NCT01388920, Phase 2, Terminated, Theratechnologies; results first posted 2014-05-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting. Trials, record NCT01388920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01388920
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
- NCT number
- NCT01388920
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Theratechnologies
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Tesamorelin, Placebo
- First posted
- 2011-07-07
- Last updated
- 2022-03-18
- Results first posted
- 2014-05-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Change From Baseline in Exercise Capacity at 6 Months | 6 months | |
| Secondary | Change From Baseline in Peripheral Muscle Strength at 6 Months | 6 months | |
| Secondary | Change From Baseline in Patient-reported Outcomes at 6 Months | 6 months | |
| Secondary | Adverse Events | 6 months | Number and percentage of subjects with adverse events |
| Secondary | COPD Exacerbations | 6 months | Frequency and severity of COPD exacerbations |
| Secondary | Plasma Glucose | 6 months | Changes from baseline in fasting blood glucose |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Lean Body Mass at 6 Months | 6 months | 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. | ||
| SECONDARY | Change From Baseline in Exercise Capacity at 6 Months | 6 months | |||
| SECONDARY | Change From Baseline in Peripheral Muscle Strength at 6 Months | 6 months | |||
| SECONDARY | Change From Baseline in Patient-reported Outcomes at 6 Months | 6 months | |||
| SECONDARY | Adverse Events | 6 months | |||
| SECONDARY | COPD Exacerbations | 6 months | |||
| SECONDARY | Plasma Glucose | 6 months |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tesamorelin 2 mg | 1 | |
| Overall Study | STARTED | Tesamorelin 3 mg | 1 | |
| Overall Study | STARTED | Placebo | 0 | |
| Overall Study | COMPLETED | Tesamorelin 2 mg | 1 | |
| Overall Study | COMPLETED | Tesamorelin 3 mg | 1 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Tesamorelin 2 mg | 0 | |
| Overall Study | NOT COMPLETED | Tesamorelin 3 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tesamorelin 2 mg | ||
| Total, all-cause mortality | Tesamorelin 3 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tesamorelin 2 mg | 0 | 1 |
| Total, other adverse events | Tesamorelin 3 mg | 0 | 1 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | Tesamorelin 2 mg | 0 | 1 |
| Total, serious adverse events | Tesamorelin 3 mg | 0 | 1 |
| Total, serious adverse events | Placebo | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01388920
GET https://conductscience.org/api/trials/v1/NCT01388920/registered