A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study

What Was Tested

This registered phase 2 trial tested Bimagrumab.

This extension study was a 24-week off-drug follow-up of the core CBYM338E2202 (NCT ) study and the main objective was to determine the long-term durability of bimagrumab (BYM338) effect after a 6-month treatment period.

It had two arms (groups): Follow-up (arm 1) (other) and Follow-up (arm 2) (no intervention).

The registry classes the interventions as drug.

Who Took Part

160 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.

How the Study Was Run

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

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

Neither the participants nor the staff measuring them knew who was on Bimagrumab, so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

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

It started in 2015-07-22 with completion listed for 2018-12-03.

It ran at 30 sites in Japan (10), United States (5), Russia (4), France (2), Spain (2) and Australia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 (time frame: Week 49). Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49 (time frame: Week 49).

It also tracked 8 secondary outcomes, for example Population I: 6-minute Walking Distance (6MWT) at Week 49, Population II: 6-minute Walking Distance (6MWT) at Week 49, Population I: Gait Speed at Week 49, Population II: Gait Speed at Week 49, Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 and Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Bimagrumab in 160 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.