Trial · NCT01669174
BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
NCT01669174, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2016-05-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia. Trials, record NCT01669174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01669174
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
- NCT number
- NCT01669174
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD) With Cachexia
- Interventions
- Placebo, BYM338
- First posted
- 2012-08-20
- Last updated
- 2016-05-03
- Results first posted
- 2016-05-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 | Baseline, Weeks 4, 8, 16, 24 | Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 4,8,16 and 24 was considered responders. |
| Secondary | Change in 6 Minute Walk Distance Compared to Placebo | Baseline, Weeks 4, 8, 16, 24 | Practical simple test that requires a 100-ft hallway but no exercise quipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired patients. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD) |
| Secondary | Maximum Observed Serum Concentration (Cmax) | 0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose | The observed maximum plasma concentration following drug administration |
| Secondary | Time to Reach the Maximum Concentration After Drug Administration (Tmax) | 24 weeks | The time to reach the maximum concentration after drug administration |
| Secondary | AUC0-56 and AUClast | 0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose | AUC0-56, the area under the serum concentration-time curve from the time zero to the end of the dosing interval, day 56. AUC0-56 was analyzed for dose 1 and 2. AUClast is from time zero to the last quantifiable concentration. AUClast was analyzed for dose 2 only. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 | Baseline, Weeks 4, 8, 16, 24 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame. | Percentage Change of TMV | MEAN |
| SECONDARY | Change in 6 Minute Walk Distance Compared to Placebo | Baseline, Weeks 4, 8, 16, 24 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame | meter | MEAN |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) | 0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose | Pharmacokinetics (PK) analysis set: Patients with evaluable PK data. | ug/mL | MEAN |
| SECONDARY | Time to Reach the Maximum Concentration After Drug Administration (Tmax) | 24 weeks | Pharmacokinetics (PK) analysis set: Patients with evaluable PK data. | hr | MEDIAN |
| SECONDARY | AUC0-56 and AUClast | 0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose | Pharmacokinetics (PK) analysis set: Patients with evaluable PK data. | day*ug/mL | MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 | BYM338 | Week 4 Day 29 (n=30,31) | 5.87 | Standard Deviation 3.413 | Percentage Change of TMV |
| Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 | Placebo | Week 4 Day 29 (n=30,31) | 0.02 | Standard Deviation 3.261 | Percentage Change of TMV |
| Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 | BYM338 | Week 8 Day 57 (n=27,27) | 7.01 | Standard Deviation 3.707 | Percentage Change of TMV |
| Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 | Placebo | Week 8 Day 57 (n=27,27) | -0.65 | Standard Deviation 2.752 | Percentage Change of TMV |
| Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 | BYM338 | Week 16 Day 113 (27,28) | 7.84 | Standard Deviation 5.052 | Percentage Change of TMV |
| Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 | Placebo | Week 16 Day 113 (27,28) | -0.88 | Standard Deviation 4.471 | Percentage Change of TMV |
| Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 | BYM338 | End of Study, week 24 (n=27,28) | 5.04 | Standard Deviation 4.872 | Percentage Change of TMV |
| Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 | Placebo | End of Study, week 24 (n=27,28) | -1.31 | Standard Deviation 4.282 | Percentage Change of TMV |
| Change in 6 Minute Walk Distance Compared to Placebo | BYM338 | Week 4 Day 29 (n=30,32) | 364.6 | Standard Deviation 85.45 | meter |
| Change in 6 Minute Walk Distance Compared to Placebo | Placebo | Week 4 Day 29 (n=30,32) | 388.5 | Standard Deviation 100.22 | meter |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BYM338 | 33 | |
| Overall Study | STARTED | Placebo | 34 | |
| Overall Study | COMPLETED | BYM338 | 27 | |
| Overall Study | COMPLETED | Placebo | 28 | |
| Overall Study | NOT COMPLETED | BYM338 | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events146
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 | Atrial fibrillation | Cardiac disorders | BYM338 30mg/kg | 0 | 33 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 2 | 34 | |
| other | Abdominal pain upper | Gastrointestinal disorders | BYM338 30mg/kg | 2 | 33 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 0 | 34 | |
| other | Diarrhoea | Gastrointestinal disorders | BYM338 30mg/kg | 7 | 33 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 34 | |
| other | Dyspepsia | Gastrointestinal disorders | BYM338 30mg/kg | 2 | 33 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 0 | 34 | |
| other | Nausea | Gastrointestinal disorders | BYM338 30mg/kg | 2 | 33 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 34 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BYM338 30mg/kg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | BYM338 30mg/kg | 31 | 33 |
| Total, other adverse events | Placebo | 30 | 34 |
| Total, serious adverse events | BYM338 30mg/kg | 4 | 33 |
| Total, serious adverse events | Placebo | 3 | 34 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30095981 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BYM338 30mg/kg vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01669174
GET https://conductscience.org/api/trials/v1/NCT01669174/results?page=2