A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults

What Was Tested

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

The purpose of this Proof of Concept study is to determine the effects of BYM338 on skeletal muscle volume, mass, and strength and patient function (gait speed) in non-demented elderly adults with sarcopenia and mobility limitations.

Furthermore, the extended study duration will provide information on the stability of BYM-induced changes in skeletal muscle and patient function in this subgroup of the older population.

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

BYM338 active drug.

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: At the onsite screening, candidates should have gait speed measured over 4 meters of \<1.0 m/s but ≥0.6 m/s. Oral body temperature between 35.0-37.5 °C. Pulse rate, 50 - 100 bpm. Be able to communicate well with the investigator, to understand and comply with the requirements of the study.

The full record lists 11 inclusion and 9 exclusion criteria; among the exclusions: history of hypersensitivity to antibodies; diseases known to cause malabsorption of protein or energy, including inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency, etc; any single transaminase listed above may not exceed 3x upper limit of normal (uln).

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Bimagrumab and who got the comparison, which limits bias.

The Bimagrumab group and the comparison group ran side by side rather than switching.

As a double-blind Bimagrumab study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2012-01 with completion listed for 2013-12.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: muscle volume of the thigh (measurement gathered using MRI, magnetic resonance imaging) (time frame: baseline to 24 weeks).

It also tracked 6 secondary outcomes, for example Muscle function measured by evaluating physical performance tests, Health status measured by evaluating patient reports, Duration of drug-induced changes in body composition and Duration of drug-induced physical function.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Bimagrumab in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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