Trial · NCT03359473
Study to Evaluate the Safety and Efficacy of 13 Weeks of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Chronic Obstructive Pulmonary Disease (COPD)
NCT03359473, Phase 2, Completed, GlaxoSmithKline; results first posted 2020-07-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Safety and Efficacy of 13 Weeks of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT03359473. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03359473
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of 13 Weeks of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT03359473
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Cachexia
- Interventions
- GSK2881078, Matching Placebo
- First posted
- 2017-12-02
- Last updated
- 2020-07-15
- Other registries' IDs
- eudract:2017-001148-37
- Results first posted
- 2020-07-15
Source ClinicalTrials.gov
Registered outcomes56
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90 | SBP and DBP were measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Safety Population comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received. |
| Primary | Change From Baseline in Heart Rate | Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90 | Heart rate was measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. |
| Primary | Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB) | Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90 | Twelve-lead electrocardiograms (ECG) were obtained using an automated ECG machine to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. |
| Primary | Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Baseline (Day 1, Pre-dose) and up to Day 132 | Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lympho), neutrophil count (Neutro) and platelet count (PC). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Only those participants with increase to grade 3 and increase to grade 4 are presented. |
| Primary | Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters | Baseline (Day 1, Pre-dose) and up to Day 132 | Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin (Bil),calcium (Ca), cholesterol (Chol), creatinine (Creat), glucose(Gl), phosphate (Phos), potassium (Pot) and sodium (Sod). The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Values (Hyper and hypo) for Ca, Gl, Pot, Phos and Sod is presented. Only those participants with increase to grade 3 and increase to grade 4 are presented. |
| Primary | Change From Baseline in Urinalysis Parameter; Specific Gravity: Placebo-Female Participants | Baseline (Day 1, Pre-dose), Days 28, 56 and 90 | Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. |
| Primary | Change From Baseline in Urinalysis Parameter; Specific Gravity: GSK2881078 1.0 mg- Female Participants | Baseline (Day 1, Pre-dose), Days 14 and 90 | Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. |
| Primary | Change From Baseline in Urinalysis Parameter; Specific Gravity: Male Participants | Baseline (Day 1, Pre-dose), Days 28 and 90 | Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. |
| Primary | Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH): Placebo- Female Participants | Baseline (Day 1, Pre-dose), Days 28, 56 and 90 | Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. |
| Primary | Change From Baseline in Urinalysis Parameter; pH: GSK2881078 1.0 mg- Female Participants | Baseline (Day 1, Pre-dose), Days 14 and 90 | Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 registered outcomesOutcomes56
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 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Millimeters of mercury | MEAN |
| PRIMARY | Change From Baseline in Heart Rate | Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Beats per minute | MEAN |
| PRIMARY | Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB) | Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Milliseconds | MEAN |
| PRIMARY | Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Baseline (Day 1, Pre-dose) and up to Day 132 | Safety Population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters | Baseline (Day 1, Pre-dose) and up to Day 132 | Safety Population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Urinalysis Parameter; Specific Gravity: Placebo-Female Participants | Baseline (Day 1, Pre-dose), Days 28, 56 and 90 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Ratio | MEAN |
| PRIMARY | Change From Baseline in Urinalysis Parameter; Specific Gravity: GSK2881078 1.0 mg- Female Participants | Baseline (Day 1, Pre-dose), Days 14 and 90 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Ratio | MEAN |
| PRIMARY | Change From Baseline in Urinalysis Parameter; Specific Gravity: Male Participants | Baseline (Day 1, Pre-dose), Days 28 and 90 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Ratio | MEAN |
| PRIMARY | Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH): Placebo- Female Participants | Baseline (Day 1, Pre-dose), Days 28, 56 and 90 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | pH | MEAN |
| PRIMARY | Change From Baseline in Urinalysis Parameter; pH: GSK2881078 1.0 mg- Female Participants | Baseline (Day 1, Pre-dose), Days 14 and 90 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | pH | MEAN |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 outcomesResults by group706
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Placebo- Female Participants | SBP,Day 14,n=22,23,23,24 | 3.0 | Standard Deviation 19.63 | Millimeters of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | GSK2881078 1.0 mg- Female Participants | SBP,Day 14,n=22,23,23,24 | 2.1 | Standard Deviation 11.03 | Millimeters of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Placebo- Male Participants | SBP,Day 14,n=22,23,23,24 | -2.1 | Standard Deviation 9.33 | Millimeters of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | GSK2881078 2.0 mg- Male Participants | SBP,Day 14,n=22,23,23,24 | 3.1 | Standard Deviation 11.65 | Millimeters of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Placebo- Female Participants | SBP,Day 28,n=22,20,23,24 | 3.7 | Standard Deviation 12.76 | Millimeters of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | GSK2881078 1.0 mg- Female Participants | SBP,Day 28,n=22,20,23,24 | -0.1 | Standard Deviation 12.82 | Millimeters of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Placebo- Male Participants | SBP,Day 28,n=22,20,23,24 | 2.6 | Standard Deviation 14.39 | Millimeters of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | GSK2881078 2.0 mg- Male Participants | SBP,Day 28,n=22,20,23,24 | 5.8 | Standard Deviation 9.49 | Millimeters of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Placebo- Female Participants | SBP,Day 56,n=21,19,20,21 | 3.3 | Standard Deviation 14.96 | Millimeters of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | GSK2881078 1.0 mg- Female Participants | SBP,Day 56,n=21,19,20,21 | 7.8 | Standard Deviation 16.38 | Millimeters of mercury |
1 to 10 of 706Source ClinicalTrials.gov
See all 706 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo- Female Participants | 23 | |
| Overall Study | STARTED | GSK2881078 1.0 mg- Female Participants | 24 | |
| Overall Study | STARTED | Placebo- Male Participants | 24 | |
| Overall Study | STARTED | GSK2881078 2.0 mg- Male Participants | 25 | |
| Overall Study | COMPLETED | Placebo- Female Participants | 21 | |
| Overall Study | COMPLETED | GSK2881078 1.0 mg- Female Participants | 18 | |
| Overall Study | COMPLETED | Placebo- Male Participants | 18 | |
| Overall Study | COMPLETED | GSK2881078 2.0 mg- Male Participants | 20 | |
| Overall Study | NOT COMPLETED | Placebo- Female Participants | 2 | |
| Overall Study | NOT COMPLETED | GSK2881078 1.0 mg- Female Participants | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Placebo- Female Participants | 6 | 23 | 6 |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | GSK2881078 1.0 mg- Female Participants | 7 | 24 | 8 |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Placebo- Male Participants | 2 | 24 | 2 |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | GSK2881078 2.0 mg- Male Participants | 3 | 25 | 4 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo- Female Participants | 0 | 23 | 0 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | GSK2881078 1.0 mg- Female Participants | 0 | 24 | 0 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo- Male Participants | 2 | 24 | 2 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | GSK2881078 2.0 mg- Male Participants | 1 | 25 | 1 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Placebo- Female Participants | 1 | 23 | 1 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | GSK2881078 1.0 mg- Female Participants | 0 | 24 | 0 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo- Female Participants | 0 | 23 |
| Total, all-cause mortality | GSK2881078 1.0 mg- Female Participants | 0 | 24 |
| Total, all-cause mortality | Placebo- Male Participants | 0 | 24 |
| Total, all-cause mortality | GSK2881078 2.0 mg- Male Participants | 0 | 25 |
| Total, other adverse events | Placebo- Female Participants | 15 | 23 |
| Total, other adverse events | GSK2881078 1.0 mg- Female Participants | 18 | 24 |
| Total, other adverse events | Placebo- Male Participants | 13 | 24 |
| Total, other adverse events | GSK2881078 2.0 mg- Male Participants | 17 | 25 |
| Total, serious adverse events | Placebo- Female Participants | 1 | 23 |
| Total, serious adverse events | GSK2881078 1.0 mg- Female Participants | 2 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03359473
GET https://conductscience.org/api/trials/v1/NCT03359473/registered?page=2