BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia

What Was Tested

In this phase 2 trial, researchers set out to test Bimagrumab.

The primary outcome will be a change in thigh muscle volume compared to placebo.

The study will last for approximately 24 weeks.

It had two arms (groups): BYM338 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 67 actual participants took part.

It was open to people of any sex aged from 40 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Written informed consent must be obtained before any assessment is performed. Males and females ages 40 to 80 years. Smoking history of at least 10 pack-years. BMI \<20 kg/m2 or skeletal muscle mass index by DXA \< 7.25 kg/m2 for men or \<5.45 kg/m2 for women. In general stable health, including managed COPD, by past medical history, physical examination, vital signs at baseline as determined by the investigator.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: patients with mrc dyspnoea grade 5 (i.e. patients too breathless to leave the house or breathless when dressing); inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency; liver disease or liver injury.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Bimagrumab study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Bimagrumab.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-09 with completion listed for 2014-12.

It ran at 9 sites in United States (5), United Kingdom (3) and Netherlands (1).

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 (time frame: Baseline, Weeks 4, 8, 16, 24).

It also tracked 4 secondary outcomes, for example Change in 6 Minute Walk Distance Compared to Placebo, Maximum Observed Serum Concentration (Cmax), Time to Reach the Maximum Concentration After Drug Administration (Tmax) and AUC0-56 and AUClast.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Bimagrumab in 67 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Bimagrumab compound page, all human trials.