Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery

56-week, Randomized, Multicenter, Double Blind, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass and Physical Performance in Patients After Surgical Treatment of Hip Fracture

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222609

Enrollment

210

Registered

2014-09-26

Start date

2015-09-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Wasting (Atrophy) After Hip Fracture Surgery

Interventions

investigational material(s) Generic name etc : BYM338 INN of investigational material : Bimagrumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Must have X-ray confirmed successful hip fracture repair; must have completed surgical wound healing; ability to walk a specified distance with or without a walking aid; must weigh at least 35 kg.

Exclusion criteria

Exclusion criteria: Must not have history of fracture of the same hip; Must not have history of any other lower limb fractures in the past 6 months; Must meet cardiovascular requirements; Must not have a chronic active infection (e.g. HIV, hepatitis B or C, etc); Must not have used high-dose corticosteroid medications for at least 3 months in the past year; Other protocol-defined inclusion and exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
efficacy Change from baseline in total lean body mass measured by DXA at week 24 [ Time Frame: Baseline, Week 24 ] Change from baseline to Week 24 in total lean body mass	—

Secondary

Measure	Time frame
efficacy Change from baseline in gait speed at week 24 and week 52[ Time Frame: Baseline, Week 24 and Week 52 ] Change from baseline to Week 24 and from baseline to Week 52 in gait speed (meters/sec) efficacy Change from baseline in short physical performance battery at week 24 and week 52 [ Time Frame: Baseline, Week 24 and Week 52 ] Change from baseline to Week 24 and from baseline to Week 52 in physical performance as measured by the Short Physical Performance Battery safety Safety and Tolerability of bimagrumab assessed by various measures such as adverse events [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 ] Safety and Tolerability assessed by various measures such as adverse events efficacy Change from baseline in total lean body mass measured by DXA at week 52 [ Time Frame: Baseline, Week 52 ] Change from baseline to Week 52 in total lean body mass	—

Measure

Time frame

efficacy Change from baseline in gait speed at week 24 and week 52[ Time Frame: Baseline, Week 24 and Week 52 ] Change from baseline to Week 24 and from baseline to Week 52 in gait speed (meters/sec) efficacy Change from baseline in short physical performance battery at week 24 and week 52 [ Time Frame: Baseline, Week 24 and Week 52 ] Change from baseline to Week 24 and from baseline to Week 52 in physical performance as measured by the Short Physical Performance Battery safety Safety and Tolerability of bimagrumab assessed by various measures such as adverse events [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 ] Safety and Tolerability assessed by various measures such as adverse events efficacy Change from baseline in total lean body mass measured by DXA at week 52 [ Time Frame: Baseline, Week 52 ] Change from baseline to Week 52 in total lean body mass

—

Countries

Asia except Japan, Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026