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NCT01669174 · ClinicalTrials.gov registry record · Phase 2
BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT01669174: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01669174 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01669174, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo. The study will last for approximately 24 weeks.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG BYM338
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01669174 record still lists
NCT01669174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01669174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01669174 about?
NCT01669174 is a clinical study titled "BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia". This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo. The study will last for approximately 24 weeks.
What is the current status of trial NCT01669174?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2012-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01669174?
The interventions under investigation include: Placebo (DRUG), BYM338 (DRUG).
Who is sponsoring clinical trial NCT01669174?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01669174's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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