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Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery
Plain-language guide to NCT02152761: phase 2 randomized trial of Bimagrumab, 251 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02152761
- Phase
- phase 2
- Status
- completed
- Start
- 2014-09-16
- Completion (planned or actual)
- 2018-05-14
- Participants
- 251 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Muscle Wasting (Atrophy) After Hip Fracture Surgery
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Bimagrumab.
It had four arms (groups): one (experimental), one (experimental), placebo (placebo comparator) and one (experimental).
Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria received matching placbo administered via intravenous infusion starting Day 1 until Week 20.
The registry classes the interventions as drug and other.
Who Took Part
The registry lists 251 actual participants took part.
It was open to people of any sex aged from 60 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, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Bimagrumab group and the comparison group should start out alike.
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 2014-09-16 with completion listed for 2018-05-14.
It ran at 53 sites in United States (6), Czechia (6), Japan (6), Germany (4), Russia (4) and Spain (4).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24 (time frame: baseline, weeks 12 and 24).
It also tracked 3 secondary outcomes, for example Change From Baseline in Gait Speed at Week 24 (Meters/Sec), Change From Baseline in Short Physical Performance Battery at Weeks 24 and Incidence of Falls up to Week 48.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Bimagrumab in 251 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.
Our Notes on the Compound
Bimagrumab: A monoclonal antibody that blocks activin type II receptors, studied by Lilly (via Versanis) to cut fat while keeping muscle during GLP-1 weight loss.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.