Dose Range Finding Study of Bimagrumab in Sarcopenia

What Was Tested

The trial (phase 2) is built around Bimagrumab.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 217 actual participants took part.

It was open to people of any sex aged from 70 years with no upper age limit.

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

Examples of who could join: Low muscle mass as confirmed by DXA;. Low gait speed \<0.8 m/s. SPPB score less than or equal to 9;. Weigh at least 35 kg;. Adequate dietary intake;.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: requires regular assistance from another person for general activities of daily living (e.g. bathing, dressing, toileting); intraocular surgery and laser procedures for refractive correction within 6 months prior to screening;; any underlying muscle disease including active myopathy or muscular dytrophy;.

How the Study Was Run

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

The participants were allocated by chance, so the Bimagrumab group and the comparison group should start out alike.

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

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 2014-12-09 with completion listed for 2018-06-26.

It ran at 58 sites in United States (17), Japan (12), France (4), Russia (4), Spain (4) and Czechia (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25 (time frame: Baseline, week 25).

It also tracked 4 secondary outcomes, for example Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance, Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters, Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA) and Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Bimagrumab in 217 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.