Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients

An Exploratory, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of BYM338 on Muscle in Patients Requiring Prolonged Mechanical Ventilation

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01868685

Enrollment

Registered

2013-06-04

Start date

2014-04-30

Completion date

2015-01-31

Last updated

2015-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation

Keywords

Muscle, anabolism, cachexia, respiratory failure, diaphragm

Brief summary

The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.

Interventions

DRUGBYM338

BYM338

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Adults on mechanical ventilation for at least 7 days with a tracheostomy in place for \>24 hours. * Expected to survive at least 14 days. * Receiving adequate nutritional support, defined as at least 20 kcal/kg and 0.6 g/kg protein per day (unless lower protein intake required by clinical status).

Exclusion criteria

* Patients deemed to be terminal wean patients. * Patients who have progressive neuromuscular degenerative disorders. * Patients who are comatose. * Evidence of unstable medical status.

Design outcomes

Primary

Measure	Time frame
Change in thigh muscle thickness	After 14 days

Secondary

Measure	Time frame
Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients	After 12 weeks
Number of patients with adverse events as a measure of safety and tolerability	After 12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026