Bimagrumab Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Bimagrumab comprises 7 peer-reviewed publications across 6 journals, 4 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Muscular Atrophy, Obesity, and Myositis, Inclusion Body. Most recent publication: Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial., Nat Med, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Long-term safety and tolerability of bimagrumab (BYM338) in sporadic inclusion body myositis.
    Sivakumar K, Cochrane TI, Sloth B, et al. · Neurology · 2020
    PubMed: PMID 32690797 · NCT02250443 (BYM338) · Myositis, Inclusion Body
  2. Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial.
    Rooks D, Swan T, Goswami B, et al. · JAMA Netw Open · 2021
    PubMed: PMID 33074327 · NCT02333331 · Muscular Atrophy
  3. Association of Appendicular Skeletal Muscle Mass Index and Insulin Resistance With Mortality in Multi-Nationwide Cohorts.
    Moon S, Choi JW, Park JH, et al. · J Cachexia Sarcopenia Muscle · 2025
    PubMed: PMID 40230053 · NCT05616013 · Obesity
  4. Bimagrumab to improve recovery after hip fracture in older adults: a multicentre, double-blind, randomised, parallel-group, placebo-controlled, phase 2a/b trial.
    Hofbauer LC, Witvrouw R, Varga Z, et al. · Lancet Healthy Longev · 2022
    PubMed: PMID 36098133 · NCT02152761 · Muscular Atrophy
  5. Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial.
    Heymsfield SB, Aronne LJ, Montgomery P, et al. · Nat Med · 2026
    PubMed: PMID 41772149 · NCT05616013 · Obesity
  6. Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial.
    Hanna MG, Badrising UA, Benveniste O, et al. · Lancet Neurol · 2020
    PubMed: PMID 31397289 · NCT01925209 (RESILIENT) · Muscular Atrophy
  7. Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT.
    Amato AA, Hanna MG, Machado PM, et al. · Neurology · 2021
    PubMed: PMID 33597289 · NCT02573467 · Muscular Atrophy

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT01925209
RESILIENT
Muscular AtrophyChange From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52
Baseline, Week 52
BYM338/Bimagrumab 1 mg/kg-10.27 meters (±10.718 Standard Error)
BYM338/Bimagrumab 10 mg/kg8.63 meters (±10.934 Standard Error)
BYM338/Bimagrumab 3 mg/kg9.63 meters (±10.770 Standard Error)
Placebo-8.96 meters (±10.765 Standard Error)
NCT02250443
BYM338
Myositis, Inclusion BodyNumber of Participants With Adverse Events as a Measure of Safety and Tolerability
Up to 29 month
BYM3380 Participants
BYM3382 Participants
BYM33810 Participants
NCT02573467Muscular AtrophyChange From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)
Core study baseline, weeks 52, 78, 104, and >=117
BYM338/Bimagrumab 1 mg/kg-14.26 meters (±81.029 Standard Deviation)
BYM338/Bimagrumab 1 mg/kg-53.65 meters (±114.322 Standard Deviation)
BYM338/Bimagrumab 1 mg/kg-25.08 meters (±95.737 Standard Deviation)
BYM338/Bimagrumab 1 mg/kg-18.66 meters (±81.536 Standard Deviation)
BYM338/Bimagrumab 10 mg/kg6.88 meters (±68.948 Standard Deviation)
BYM338/Bimagrumab 10 mg/kg-22.68 meters (±102.549 Standard Deviation)
BYM338/Bimagrumab 10 mg/kg-5.25 meters (±122.002 Standard Deviation)
BYM338/Bimagrumab 10 mg/kg-206.65 meters (±281.923 Standard Deviation)
BYM338/Bimagrumab 3 mg/kg-5.0 meters (±NA Standard Deviation)
BYM338/Bimagrumab 3 mg/kg-50.58 meters (±118.012 Standard Deviation)
BYM338/Bimagrumab 3 mg/kg-9.73 meters (±68.302 Standard Deviation)
BYM338/Bimagrumab 3 mg/kg9.48 meters (±81.676 Standard Deviation)
Placebo31.60 meters (±NA Standard Deviation)
Placebo-5.98 meters (±78.817 Standard Deviation)
Placebo-32.78 meters (±96.494 Standard Deviation)
Placebo-61.30 meters (±107.399 Standard Deviation)
NCT02573467Muscular AtrophyNumber of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.
to end of study (up to 14 months, including the 6-month treatment-free follow-up period)
BYM338/Bimagrumab 1 mg/kg7 Participants
BYM338/Bimagrumab 1 mg/kg44 Participants
BYM338/Bimagrumab 1 mg/kg1 Participants
BYM338/Bimagrumab 10 mg/kg12 Participants
BYM338/Bimagrumab 10 mg/kg1 Participants
BYM338/Bimagrumab 10 mg/kg48 Participants
BYM338/Bimagrumab 3 mg/kg50 Participants
BYM338/Bimagrumab 3 mg/kg1 Participants
BYM338/Bimagrumab 3 mg/kg10 Participants
Placebo49 Participants
Placebo2 Participants
Placebo8 Participants

Publications by year

2020–2026: 7 publications.

2020
2
2021
2
2022
1
2025
1
2026
1

Publications by indication

Muscular Atrophy (4)

  • Bimagrumab to improve recovery after hip fracture in older adults: a multicentre, double-blind, randomised, parallel-group, placebo-controlled, phase 2a/b trial.
    Lancet Healthy Longev · 2022 · PMID 36098133 · NCT02152761
  • Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial.
    JAMA Netw Open · 2021 · PMID 33074327 · NCT02333331
  • Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT.
    Neurology · 2021 · PMID 33597289 · NCT02573467
  • Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial.
    Lancet Neurol · 2020 · PMID 31397289 · NCT01925209

Obesity (2)

  • Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial.
    Nat Med · 2026 · PMID 41772149 · NCT05616013
  • Association of Appendicular Skeletal Muscle Mass Index and Insulin Resistance With Mortality in Multi-Nationwide Cohorts.
    J Cachexia Sarcopenia Muscle · 2025 · PMID 40230053 · NCT05616013

Myositis, Inclusion Body (1)

  • Long-term safety and tolerability of bimagrumab (BYM338) in sporadic inclusion body myositis.
    Neurology · 2020 · PMID 32690797 · NCT02250443

Publications by journal

Trial-results highlights

In the RESILIENT study (NCT01925209) for muscular atrophy, the change from baseline in the 6 Minute Walking Distance (6MWD) test at Week 52 was observed. Participants receiving Bimagrumab 1 mg/kg showed a change of -10.27 meters. For those on Bimagrumab 10 mg/kg, the change was 8.63 meters, and for Bimagrumab 3 mg/kg, it was 9.63 meters. Participants receiving placebo had a change of -8.96 meters. Another study, NCT02573467, also investigated changes from core study baseline in the 6MWD test. In the Bimagrumab 1 mg/kg arm, mean changes were reported as:

  • -14.26 meters
  • -53.65 meters
  • -25.08 meters
  • -18.66 meters

In the Bimagrumab 10 mg/kg arm, mean changes were 6.88 meters and -22.68 meters.

Safety and tolerability were assessed in several studies. In NCT02573467, which included a 6-month treatment-free follow-up period, the number of participants with adverse events (AEs), serious adverse events (SAEs), and deaths were reported. In the Bimagrumab 1 mg/kg arm, there were:

  • 7 Participants with AEs
  • 44 Participants with SAEs
  • 1 Participant with a death

In the Bimagrumab 10 mg/kg arm, there were:

  • 12 Participants with AEs
  • 1 Participant with an SAE
  • 48 Participants with deaths

For inclusion body myositis, the NCT02250443 study reported the number of participants with adverse events as a measure of safety and tolerability up to 29 months. In the BYM338 arm, there were:

  • 0 Participants
  • 2 Participants
  • 10 Participants

reported for adverse events.

All values presented are sourced from primary registry reporting, and individual study publications should be consulted for clinical decision-making.

All Bimagrumab publications (7)

2026 (1 paper)

  1. Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial.
    Heymsfield SB, Aronne LJ, Montgomery P, et al. · Nat Med · 2026 · Derived
    PubMed: PMID 41772149 · NCT05616013 · Obesity

2025 (1 paper)

  1. Association of Appendicular Skeletal Muscle Mass Index and Insulin Resistance With Mortality in Multi-Nationwide Cohorts.
    Moon S, Choi JW, Park JH, et al. · J Cachexia Sarcopenia Muscle · 2025 · Derived
    PubMed: PMID 40230053 · NCT05616013 · Obesity

2022 (1 paper)

  1. Bimagrumab to improve recovery after hip fracture in older adults: a multicentre, double-blind, randomised, parallel-group, placebo-controlled, phase 2a/b trial.
    Hofbauer LC, Witvrouw R, Varga Z, et al. · Lancet Healthy Longev · 2022 · Derived
    PubMed: PMID 36098133 · NCT02152761 · Muscular Atrophy

2021 (2 papers)

  1. Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial.
    Rooks D, Swan T, Goswami B, et al. · JAMA Netw Open · 2021 · Derived
    PubMed: PMID 33074327 · NCT02333331 · Muscular Atrophy
  2. Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT.
    Amato AA, Hanna MG, Machado PM, et al. · Neurology · 2021 · Derived
    PubMed: PMID 33597289 · NCT02573467 · Muscular Atrophy

2020 (2 papers)

  1. Long-term safety and tolerability of bimagrumab (BYM338) in sporadic inclusion body myositis.
    Sivakumar K, Cochrane TI, Sloth B, et al. · Neurology · 2020 · Derived
    PubMed: PMID 32690797 · NCT02250443 (BYM338) · Myositis, Inclusion Body
  2. Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial.
    Hanna MG, Badrising UA, Benveniste O, et al. · Lancet Neurol · 2020 · Derived
    PubMed: PMID 31397289 · NCT01925209 (RESILIENT) · Muscular Atrophy

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).