Monoclonal Antibody — Activin Type II Receptor Blocker
Bimagrumab
Phase IIBYM338 · LY3985863 · VER201 · not a peptide: a monoclonal antibody
A lab-made human antibody that blocks the two receptors myostatin and activins use to hold back muscle growth. Novartis tested it for muscle loss, then obesity; it has since been tested with semaglutide, and Eli Lilly now tests it with tirzepatide.
- Molecular Weight
- ~143 kDa (calculated, FDA substance registry)
- Class
- Human IgG1 lambda monoclonal antibody
- Half-life
- Not in the documents read · non-linear, target-mediated clearance
- Route
- IV infusion (most trials); under the skin (Lilly’s current trials)
- FDA Status
- Not approved · investigational
- Pipeline
- Phase 2 with tirzepatide, under the skin (Eli Lilly; active, not recruiting; primary completion was January 2026, no results posted) (NCT06643728); Phase 2 with tirzepatide, 300 mg weekly under the skin (Massachusetts General Hospital; recruiting) (NCT05933499), primary completion est. Dec 2028
- Published Studies
- 79 on PubMed · 17 trial reports
- Human Studies
- Phase 2 RCTs · largest 507 adults (BELIEVE)
- WADA Status
- Prohibited at all times (S4.3, named)
- Evidence Strength
- Fat loss: Phase 2 RCTs (75 and 507 adults)
Muscle function: no gain in the larger RCTs - Cost & Access
- Clinical trials · research-use lab reagents
Research only · not on any FDA 503A list · Tell me if this changes →
What does it do? It binds both activin type II receptors, ActRIIA and ActRIIB, where myostatin and activins would bind, and blocks their signal (Morvan et al., 2017). In trials, muscle mass went up and fat went down; its trialists write that it “does not appear to affect food intake” (Heymsfield et al., 2026).
Who uses it? In the documents read for this page, only people in clinical trials. Novartis tested it in people losing muscle (inclusion body myositis, sarcopenia, recovery from hip fracture, COPD) and in type 2 diabetes with obesity; BELIEVE then tested it alone and with semaglutide, and Eli Lilly’s current trials test it alone and with tirzepatide.
Does the evidence hold up? In controlled Phase 2 trials, fat fell and lean mass rose slightly on bimagrumab alone. In BELIEVE, 507 adults with obesity, weight fell 9.3 kg on bimagrumab 30 mg/kg alone, 14.2 kg on semaglutide 2.4 mg and 17.8 kg on both, against 3.3 kg on placebo, at 48 weeks (Heymsfield et al., 2026). In people losing muscle, no larger trial improved walking distance or physical performance, though lean mass rose in the sarcopenia and hip-fracture trials. Every published trial was funded or sponsored by the companies developing it: Novartis, then Versanis and Lilly.
Bottom line? A drug candidate in Phase 2, with published controlled data and no FDA approval. Outside trials, the only copies documented here are laboratory reagents labelled for research use, and WADA prohibits it at all times.
Dosing from the Literature
Published for fat loss: trial doses by IV infusion: 10 mg/kg every 4 weeks, or 10 or 30 mg/kg every 12 weeks after two loading doses, for 48 weeks. Not published: an approved dose, or any obesity result from the under-the-skin dosing Lilly now tests.
No dose of bimagrumab is approved. The rows are trial doses and one registered regimen, as the documents give them; they are not recommendations. Most trials dosed by body weight: at 30 mg/kg, a 100 kg adult receives 3,000 mg in one infusion. Lilly’s registry entries for its under-the-skin trials give no amounts; its Phase 2 names them only “Dose 1” and “Dose 2” (ClinicalTrials.gov NCT06643728).
| Source | Amount | Frequency | Duration | Population | Notes |
|---|---|---|---|---|---|
| Trial dose: Heymsfield et al., 2021 (NCT03005288) | 10 mg/kg, up to 1,200 mg, IV infusion in 5% dextrose | Every 4 weeks | 48 weeks | 75 adults with type 2 diabetes, BMI 28–40 | Diet and exercise counseling in both groups. Fat mass −20.5% vs −0.5% on placebo. |
| Trial dose: BELIEVE, Heymsfield et al., 2026 (NCT05616013) | 10 or 30 mg/kg, 30-minute IV infusion at the trial site, by body weight | Loading doses at week 1 and week 4, then every 12 weeks | 48 weeks blinded, open-label to week 72 | 507 adults with obesity (BMI ≥30, or ≥27 with a complication), no diabetes | Alone or with open-label semaglutide 1.0 or 2.4 mg a week. Monthly counseling toward a daily deficit of about 500 kcal, ≥1.2 g/kg protein a day and ≥150 minutes of activity a week. |
| Trial dose: Rooks et al., 2026 | 10 mg/kg IV | Monthly | 6 months | 68 healthy adults aged 60–86 | Cardiac-safety study. |
| Trial doses: Petricoul et al., 2023 | IV 700 or 210 mg; subcutaneous infusion 1,500 or 525 mg; subcutaneous injection 300, 150 or 52.5 mg | IV and subcutaneous infusion every 4 weeks (3 doses); injection weekly (12 doses) | 12 weeks, followed to week 20 | 91 adults aged ≥70 | Phase 1 pharmacokinetics study. About 40% of an under-the-skin dose reached the blood. |
| Trial doses: RESILIENT, Hanna et al., 2019 (NCT01925209) | 1, 3 or 10 mg/kg IV | Every 4 weeks | At least 48 weeks | 251 adults with inclusion body myositis | No dose improved the 6-minute walk at week 52. |
| Trial dose: Rooks, Swan et al., 2020 (NCT02333331) | 700 mg IV | Monthly | 6 months | 180 adults aged ≥70 with sarcopenia | Diet and home exercise in both groups. |
| Trial doses: Hofbauer et al., 2021 (NCT02152761) | 70, 210 or 700 mg IV | Every 4 weeks | 24 weeks | 250 adults aged ≥60 after hip-fracture surgery | Lean mass rose on 210 and 700 mg; mobility did not improve. |
| Trial doses: Polkey et al., 2019 (NCT01669174); Rooks, Laurent et al., 2017 | 30 mg/kg IV | COPD: weeks 0 and 8. After 2 weeks in a leg cast: once | 24 weeks; 12 weeks | 67 adults with COPD; 24 healthy young men | Thigh muscle volume rose in both. |
| Registered regimen: Massachusetts General Hospital (NCT05933499) | 300 mg under the skin | Weekly | 52 weeks | 63 adults with obesity (planned) | With tirzepatide 15 mg weekly, or alone. Recruiting; no results. |
Every dose of bimagrumab with published results was given in a supervised clinical trial to screened volunteers, most often as an infusion at the trial site. These rows record what the trials gave; they are not a dosing guide. Always work with a licensed healthcare provider.
What It Is
Bimagrumab is “a fully human monoclonal antibody” (Hanna et al., 2019) against the activin type II receptors. FDA’s substance registry records it as an IgG1 lambda antibody made of four protein chains, two of 445 amino acids and two of 217, with a calculated mass of about 143,000 daltons (GSRS, UNII N15SW1DIV8). It is not a peptide. Novartis developed it under the code BYM338 and described it in 2014 as “a novel, human anti-ActRII antibody” (Lach-Trifilieff et al., 2014).
Novartis’s trials started in 2011, in people losing muscle: inclusion body myositis, sarcopenia, recovery after hip fracture, COPD and cancer cachexia (ClinicalTrials.gov). From 2017 to 2019 it ran a 48-week trial in adults with type 2 diabetes and obesity (Heymsfield et al., 2021). Versanis Bio, which Aditum Bio founded in 2021, then made bimagrumab its lead asset and took it into BELIEVE, an obesity trial alone and with semaglutide. Eli Lilly agreed to buy Versanis on July 14, 2023, for up to $1.925 billion in cash, and completed the purchase on August 14, 2023 (Lilly press releases). In Lilly’s trials the drug is LY3985863, and one completed Phase 1 study tested it coformulated with tirzepatide (ClinicalTrials.gov NCT06890611).
On September 29, 2026, PubMed returned 79 records naming bimagrumab or BYM338 in the title or abstract, 17 of them indexed as clinical trials. ClinicalTrials.gov lists 18 bimagrumab studies: 14 completed, 2 withdrawn before enrolling anyone, 1 active but no longer recruiting and 1 recruiting. Searches of FDA’s Drugs@FDA data and of DailyMed found no approved product.
Mechanism of Action
Receptor and pathway names below are the cited papers’ own.
- ActRIIA and ActRIIB (the target) — In crystal structures, bimagrumab binds the ligand-binding domains of both activin type II receptors “in a competitive manner at the critical myostatin/activin binding site,” with picomolar affinity (Morvan et al., 2017).
- Both receptors, not one — In cells, antibodies against one receptor cut myostatin and activin A signaling by only 30–50%. In mice, single-receptor antibodies raised body weight about 10%, against 16–22% with bimagrumab; the authors conclude that full neutralization needs both receptors blocked (Morvan et al., 2017).
- Myostatin, GDF11 and activins → Smad2/3 (the brake) — Myostatin, GDF11 and the activins signal through these receptors. Bimagrumab prevented myostatin- or activin A-induced atrophy by blocking Smad2/3 phosphorylation, and enhanced differentiation of primary human skeletal myoblasts (Lach-Trifilieff et al., 2014).
- ALK4 in muscle, ALK7 in fat — The BELIEVE authors describe two routes: myostatin and activin A signaling via ActRII and ALK4 in muscle, and activin signaling via ActRII and ALK7 in adipose tissue, which human exome studies of the INHBE gene (activin E) and the ACVR1C gene (ALK7) link to abdominal obesity. They write that by blocking ligand signaling in fat, bimagrumab increases lipid mobilization and lipolysis (Heymsfield et al., 2026).
- Food intake (apparently unaffected) — The same authors write that bimagrumab “does not appear to affect food intake.” At week 24, median daily intake fell 182.0 kcal on bimagrumab 30 mg/kg, 482.5 kcal on semaglutide 2.4 mg and 238.5 kcal on placebo (Heymsfield et al., 2026).
- Activin and FSH (the pituitary) — Activins also act on the pituitary. In healthy adults aged 55–75 given 10 mg/kg twice, FSH fell 42.16 IU/L more than on placebo in women at week 8; the effect reversed once the drug cleared, and gonadal and adrenal androgens were unaffected (Garito, Zakaria et al., 2018).
- Ligand build-up — Blocking both receptors raised circulating activin A in mice while muscle expression of its gene stayed unchanged, which the authors attribute to ligand no longer being taken up and degraded (Morvan et al., 2017).
- Pharmacokinetics — Blood levels are non-linear, which the authors attribute to target-mediated drug disposition (Rooks, Petricoul et al., 2020). About 40% of an under-the-skin dose reaches the blood, and weekly injections gave levels and effects comparable to monthly infusions (Petricoul et al., 2023). No half-life figure appears in the documents read for this page.
What the Research Shows
Animal work first, then the two meta-analyses of the human trials; each trial is under Human Data.
- Muscle in mice — Bimagrumab increased skeletal muscle mass beyond what a myostatin inhibitor achieved, and protected mice from glucocorticoid-induced atrophy and weakness (Lach-Trifilieff et al., 2014). In mice given four weeks of weekly injections, hind-limb muscles were 18–38% heavier (Morvan et al., 2017).
- Fat in animals, then in people — The 2021 trial report says preclinical studies in several species found no reduction of white fat, “indicating that this pathway behaves differently in humans” (Heymsfield et al., 2021). A later study in diet-induced obese mice did find fat loss: about 10% more lean mass with less fat mass, and with semaglutide, more fat loss than semaglutide alone while lean mass was preserved (Nunn et al., 2024).
- Cancer cachexia in mice — A mouse version of the antibody, CDD866, protected against muscle loss in a colon-cancer model, alongside cisplatin or everolimus; both combinations slowed time to progression (Hatakeyama et al., 2016).
- Bone healing in rats — In 150 rats with a cut fibula, bimagrumab had no major effect on fracture healing; young rats had a slightly smaller immature callus at day 29 (Tankó et al., 2016).
- Muscle in people — A meta-analysis of seven randomized trials in sarcopenia found thigh muscle volume up 5.29%, fat-free mass up 1.90 kg and fat mass down 4.55 kg against placebo, with no significant gain in strength, gait speed or 6-minute walk except in slower walkers (Kanbay et al., 2024).
- Fat in people — A meta-analysis of four randomized trials in 268 adults with obesity, insulin resistance or type 2 diabetes found weight down 4.85 kg, fat mass down 4.72 kg, lean mass up 1.66 kg and HbA1c down 0.13% against placebo, with LDL cholesterol up 0.47 mmol/L and more discontinuations (risk ratio 5.75), muscle spasms (10.44) and diarrhoea (4.91) (Shao et al., 2026).
Every published trial was funded or sponsored by Novartis, or by Versanis and Lilly, the companies developing bimagrumab. In muscle-wasting conditions no larger trial improved walking or physical function, though lean mass rose in the sarcopenia and hip-fracture trials. For fat loss the controlled evidence is Phase 2; no Phase 3 obesity trial is registered on ClinicalTrials.gov (searched September 29, 2026), and no obesity result from the under-the-skin doses Lilly now tests has been published.
Human Data
PubMed indexes 17 trial reports (September 29, 2026). By use:
- Insulin resistance, one dose (Garito, Roubenoff et al., 2018) — 16 people with a mean BMI of 29.3. At week 10, lean mass rose 2.7% and fat mass fell 7.9% against placebo, with body weight unchanged; HbA1c fell 0.21% at week 18, and insulin sensitivity improved by about 20% (clamp) to 40% (intravenous glucose tolerance test).
- Type 2 diabetes with obesity, 48 weeks (Heymsfield et al., 2021; NCT03005288) — 75 adults at 9 US and UK sites; 58 completed. Against placebo: fat mass −20.5% (−7.5 kg) vs −0.5%, lean mass +3.6% (1.70 kg) vs −0.8%, body weight −6.5% (−5.9 kg) vs −0.8%, waist −9.0 cm vs +0.5 cm, HbA1c −0.76 vs +0.04 percentage points (as corrected in 2021). Only participants who completed a full treatment regimen were analyzed, and the trial used a one-sided 10% significance level, which the authors say reflected the sponsor’s “willingness to accept a liberal standard of evidence.”
- BELIEVE, obesity, 72 weeks (Heymsfield et al., 2026; NCT05616013) — 507 adults without diabetes at 26 sites in the United States, Australia and New Zealand, in nine groups; 377 (74.4%) completed week 48. Weight change at 48 weeks: −3.3 kg on placebo; −6.0 kg on bimagrumab 10 mg/kg (not significantly different from placebo, p = 0.133) and −9.3 kg on 30 mg/kg; −9.8 and −14.2 kg on semaglutide 1.0 and 2.4 mg; −12.7 to −17.8 kg on the combinations. Lean mass changed +1.0% to +1.1% on bimagrumab alone, −4.7% to −6.9% on semaglutide alone and −0.8% to −2.3% on the combinations. At 72 weeks, in a post hoc analysis, weight was down 10.8% on bimagrumab 30 mg/kg, 15.7% on semaglutide 2.4 mg and 22.1% on the two together at those doses. Semaglutide was open-label, P values were nominal, and the authors write that without multiplicity adjustment “these results should not be used to infer definitive treatment effects.” Lilly funded the study, with Versanis funding part of it before the acquisition; Versanis designed and oversaw it.
- Heart, 6 months (Rooks et al., 2026) — 68 healthy adults aged 60–86 at one commercial site: no clinically relevant change in left ventricular mass or ejection fraction on cardiac MRI; lean mass +5.5% and fat mass −14% against placebo.
- Dosing studies — Single infusions in 16 older adults and 8 adults with obesity (Rooks, Petricoul et al., 2020); infusions against under-the-skin doses in 91 adults aged 70 or older, in whom lean mass rose 4–6% except on the lowest dose (Petricoul et al., 2023).
- Inclusion body myositis — In 14 patients given one dose of bimagrumab (11) or placebo (3), right thigh muscle volume rose 6.5% against placebo at 8 weeks, and 6-minute walk distance 14.6% at 16 weeks (Amato et al., 2014). RESILIENT, 251 patients at 38 sites: 6-minute walk distance at week 52 did not differ from placebo at any dose (Hanna et al., 2019); in its extension (211 patients), walking declined in every group through week 104 and the study was stopped early (Amato et al., 2021). An open-label extension after a single-dose study (10 patients, up to 2 years) found lean mass up and “no evidence of clinical improvement” (Sivakumar et al., 2020).
- Sarcopenia — In 40 adults aged 65 or older, thigh muscle volume rose 8.01% vs 0.35% at week 8; slower walkers gained 0.15 m/s of gait speed and 82 m of 6-minute walk more than on placebo at week 16 (Rooks, Praestgaard et al., 2017). In 180 adults aged 70 or older on diet and home exercise, lean mass rose 7% vs 1%, but physical performance scores (+1.34 vs +1.03, P = .13) and walk distance (P = .16) did not differ (Rooks, Swan et al., 2020).
- Hip fracture — 250 adults aged 60 or older: lean mass +1.9 kg on 210 mg and +2.8 kg on 700 mg against +0.2 kg on placebo, with no difference in gait speed or physical performance (Hofbauer et al., 2021).
- COPD and disuse — In 67 people with COPD, thigh muscle volume was +5.0% vs −1.3% at week 24, and walk distance did not rise significantly in either group (Polkey et al., 2019). In 24 young men after 2 weeks in a leg cast, thigh muscle volume was 5.1% above its pre-cast level at week 12 vs −0.1% on placebo; strength recovered in both groups within 6 weeks (Rooks, Laurent et al., 2017).
- Unpublished — A Novartis trial in 57 people with advanced lung or pancreatic cancer (NCT01433263) posted results on ClinicalTrials.gov; no paper on it was found in PubMed. Lilly’s trials with tirzepatide (NCT06643728, 252 adults; NCT06890611) and in healthy Chinese adults (NCT07030127) list no posted results, and its Phase 2b in type 2 diabetes (NCT06901349) was withdrawn before enrolling anyone, “for strategic business reasons.”
The evidence meter on the bimagrumab card reads “Human trials”: it counts published controlled trials for fat loss, the use on its tag. None has led to an approval.
Reconstitution & Storage
There is nothing to reconstitute in the documents. In Novartis’s inclusion body myositis trials, bimagrumab was “a 150 mg/mL concentrate for solution for i.v. infusion,” supplied in glass vials (ClinicalTrials.gov NCT01925209). Trial sites gave it as an intravenous infusion: in 5% dextrose solution (Heymsfield et al., 2021), over 30 minutes (Heymsfield et al., 2026) or over 2 hours (Rooks, Petricoul et al., 2020). Lilly’s current trials give it under the skin; their registry entries don’t describe that formulation.
- Dose sizes — Trial doses included 52.5 mg a week under the skin and 1,500 mg by subcutaneous infusion (Petricoul et al., 2023), and infusions of 30 mg/kg (Heymsfield et al., 2026), which is 3,000 mg for a 100 kg adult.
- Storage — No document read for this page gives storage conditions for the trial material. The two laboratory-reagent listings read give −20°C for their research-grade copies, which they label for research use only.
Side Effects & Risks
- Muscle spasms — The most common adverse event on bimagrumab alone in BELIEVE: 46.4% on 10 mg/kg and 73.7% on 30 mg/kg, against 5.5% on placebo; they ended treatment for five people, all on bimagrumab alone (Heymsfield et al., 2026). 41% vs 3% in the 2021 diabetes trial (Heymsfield et al., 2021); 57.1% vs 6.1% in healthy older adults (Rooks et al., 2026); 40–68% vs 21% in RESILIENT (Hanna et al., 2019).
- Diarrhea — 41.1% and 49.1% vs 5.5% in BELIEVE (Heymsfield et al., 2026); 41% vs 11%, most often after the first dose, in the 2021 trial (Heymsfield et al., 2021); 32–52% vs 18% in RESILIENT (Hanna et al., 2019).
- Acne — 33.9% and 43.9% vs 3.6% in BELIEVE, where four people stopped treatment for it (Heymsfield et al., 2026); 14.3% vs 0% in healthy older adults (Rooks et al., 2026).
- Stopping treatment — In BELIEVE, adverse events ended treatment for 21.4% (10 mg/kg) and 14.0% (30 mg/kg) on bimagrumab alone, against 3.6% on placebo; serious adverse events were 12.5% and 8.8% against 3.6%, and no one died (Heymsfield et al., 2026). A 2026 meta-analysis put the risk ratio for discontinuation at 5.75 (Shao et al., 2026).
- Pancreas — BELIEVE had three serious pancreatitis events: one each on placebo, bimagrumab 10 mg/kg and semaglutide 1.0 mg. Lipase rose transiently with bimagrumab (Heymsfield et al., 2026). In the 2021 trial one participant on bimagrumab was hospitalized with pancreatitis (Heymsfield et al., 2021).
- Cholesterol — LDL cholesterol rose in the first 12 weeks on bimagrumab. At week 72 it was 17.6% above baseline on 30 mg/kg alone and +0.1% on 30 mg/kg with semaglutide 2.4 mg (Heymsfield et al., 2026). The 2026 meta-analysis found LDL 0.47 mmol/L higher than on placebo (Shao et al., 2026).
- Heart — The cardiac-safety study’s authors note that in preclinical studies “an increase in cardiac size and weight accompanied the large gain in skeletal muscle mass and was reversible with drug withdrawal”; in their 68 healthy older adults, six months of 10 mg/kg a month brought no clinically relevant change in left ventricular mass or ejection fraction on cardiac MRI (Rooks et al., 2026). RESILIENT recorded no significant adverse cardiac effects on electrocardiography or echocardiography (Hanna et al., 2019).
- Bone — In BELIEVE, total-hip bone density fell significantly more than on placebo (−0.8%) with semaglutide 2.4 mg (−2.1%) and three combination groups (−2.0% to −2.3%); on bimagrumab alone it fell 1.1% and 1.5% (Heymsfield et al., 2026). A rat study found no major effect on fracture healing (Tankó et al., 2016).
- Skin cancers — Through week 48, four BELIEVE participants reported basal or squamous cell skin carcinoma, two on bimagrumab alone and two on semaglutide 2.4 mg alone; in the open-label extension, two participants reported basal cell skin carcinoma, in the bimagrumab 30 mg/kg and semaglutide 1.0 mg groups (Heymsfield et al., 2026).
- Cancer cachexia (registry results only) — In 57 people with advanced lung or pancreatic cancer, serious adverse events were posted for 18 of 29 on bimagrumab 30 mg/kg and 4 of 28 on placebo during the core period, most often “malignant neoplasm progression” (6 vs 0). The posted results don’t say whether any event was caused by the drug (ClinicalTrials.gov NCT01433263).
- Antibodies against the drug — Two participants in the 2021 trial developed non-neutralizing anti-drug antibodies that didn’t change exposure (Heymsfield et al., 2021); the 2026 cardiac study reported no immunogenicity signal (Rooks et al., 2026).
- Pregnancy — BELIEVE required women who could become pregnant to use an intrauterine device and a barrier method through at least 4 months after the last bimagrumab dose (Heymsfield et al., 2026).
- WADA prohibited — Named under S4.3, prohibited at all times. Anti-doping researchers have validated a method that detects bimagrumab in serum (Walpurgis et al., 2018).
- Identity and purity — The only copies outside trials documented here are laboratory reagents labelled for research use only. No document read for this page tests them or compares them with the trial material.
- Drug interactions — The only combination with published results is semaglutide, in BELIEVE (Heymsfield et al., 2026). Lilly’s Phase 1 study measuring blood levels of bimagrumab and tirzepatide given together (NCT06890611) and its Phase 2 with tirzepatide (NCT06643728) have no posted results.
Bloodwork & Monitoring
No document read for this page gives monitoring guidance for bimagrumab outside trial protocols. What the trials measured, and what changed:
- Lipids — Total and LDL cholesterol rose in the first 12 weeks on bimagrumab (Heymsfield et al., 2026).
- Liver and muscle enzymes — Alkaline phosphatase and creatine kinase rose, ALT and AST rose transiently, and bilirubin and GGT fell (Heymsfield et al., 2026). In the cardiac study, mean creatine kinase at 6 months was 3.7 µkat/L on bimagrumab and 1.4 on placebo (Rooks et al., 2026).
- Lipase and amylase — Early, transient rises (Heymsfield et al., 2021; Heymsfield et al., 2026).
- Magnesium — Mean levels fell on bimagrumab but stayed in the normal range (Heymsfield et al., 2026).
- FSH, LH and urate — In women, FSH fell 42.16 IU/L more than on placebo at week 8 and LH rose 2.5 IU/L (P = .08), both reversible (Garito, Zakaria et al., 2018). FSH and urate fell in the 2021 trial (Heymsfield et al., 2021).
- Heart — The trials used electrocardiography and echocardiography (Hanna et al., 2019), and cardiac MRI, CK-MB and NT-proBNP (Rooks et al., 2026).
- Body composition — DXA for fat and lean mass, and MRI for thigh muscle, in the trials above.
- Which tests fit a given person — A question for a licensed healthcare provider. This page can’t answer it.
Commonly Stacked With
Two combinations have been tested in trials: semaglutide in BELIEVE, and tirzepatide in Lilly’s trials; a hospital trial of the tirzepatide combination is recruiting. No document read for this page shows people combining bimagrumab with anything outside a trial.
BELIEVE tested bimagrumab infusions alone and with open-label weekly semaglutide in 507 adults with obesity. At 48 weeks, weight fell 17.8 kg on bimagrumab 30 mg/kg plus semaglutide 2.4 mg and 14.2 kg on semaglutide 2.4 mg alone; lean mass fell 1.3 kg and 3.9 kg (Heymsfield et al., 2026).
Lilly’s trials pair it with tirzepatide, both under the skin: a 252-adult Phase 2 that reached primary completion in January 2026 with no results posted (NCT06643728), and a completed Phase 1 of the two coformulated (NCT06890611). A trial at Massachusetts General Hospital planning 63 adults is recruiting (NCT05933499). No result of the combination was on PubMed or the registry on September 29, 2026.
Legal Status
Not FDA-approved. Bimagrumab is investigational (Heymsfield et al., 2026). Searches of FDA’s Drugs@FDA data (openFDA) and of DailyMed returned no approved product or label for it on September 29, 2026. It is not on FDA’s 503A bulk drug substances categories list (updated May 14, 2026) or on the 503A bulks list in 21 CFR 216.23. FDA designated it an orphan drug for inclusion body myositis on June 18, 2012, with Novartis as sponsor; FDA’s database lists that designation as withdrawn or revoked, and the drug as not approved for it.
WADA prohibits it at all times under S4.3, agents preventing activin receptor IIB activation: “Anti-activin receptor IIB antibodies (e.g. bimagrumab)” (Prohibited List 2026). S4.3 substances are non-Specified Substances.
ClinicalTrials.gov lists 18 bimagrumab studies (searched September 29, 2026). One is recruiting: a Phase 2 with tirzepatide at Massachusetts General Hospital (NCT05933499). One is active but no longer recruiting: Lilly’s Phase 2 with tirzepatide (NCT06643728). No Phase 3 obesity trial is registered.
No prescription product exists; the documents read for this page show bimagrumab given to people only in clinical trials. Laboratory-reagent suppliers sell research-grade copies for lab work: Selleck lists “Bimagrumab (Anti-ACVR2B)” as a solution “For research use only. Not for use in humans,” and Thermo Fisher’s Invitrogen line lists an “ACVR2B (Bimagrumab Biosimilar)” antibody as 100 µg of liquid “For Research Use Only.” No document read for this page tests these products or compares them with the trial material.
Pricing and availability vary and are set by the seller. Kalios does not sell compounds.
Next Steps
References
- Lach-Trifilieff E, Minetti GC, Sheppard K, Ibebunjo C, Feige JN, Hartmann S, Brachat S, Rivet H, Koelbing C, Morvan F, Hatakeyama S, Glass DJ. An antibody blocking activin type II receptors induces strong skeletal muscle hypertrophy and protects from atrophy. Mol Cell Biol. 2014;34(4):606-618. PMID: 24298022.
- Morvan F, Rondeau JM, Zou C, et al. Blockade of activin type II receptors with a dual anti-ActRIIA/IIB antibody is critical to promote maximal skeletal muscle hypertrophy. Proc Natl Acad Sci USA. 2017;114(47):12448-12453. PMID: 29109273.
- Amato AA, Sivakumar K, Goyal N, et al. Treatment of sporadic inclusion body myositis with bimagrumab. Neurology. 2014;83(24):2239-2246. PMID: 25381300.
- Hanna MG, Badrising UA, Benveniste O, et al. Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial. Lancet Neurol. 2019;18(9):834-844. PMID: 31397289.
- Amato AA, Hanna MG, Machado PM, et al. Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT. Neurology. 2021;96(12):e1595-e1607. PMID: 33597289.
- Sivakumar K, Cochrane TI, Sloth B, Ashar H, Laurent D, Tankó LB, Amato AA. Long-term safety and tolerability of bimagrumab (BYM338) in sporadic inclusion body myositis. Neurology. 2020;95(14):e1971-e1978. PMID: 32690797.
- Rooks D, Praestgaard J, Hariry S, et al. Treatment of Sarcopenia with Bimagrumab: Results from a Phase II, Randomized, Controlled, Proof-of-Concept Study. J Am Geriatr Soc. 2017;65(9):1988-1995. PMID: 28653345.
- Rooks DS, Laurent D, Praestgaard J, Rasmussen S, Bartlett M, Tankó LB. Effect of bimagrumab on thigh muscle volume and composition in men with casting-induced atrophy. J Cachexia Sarcopenia Muscle. 2017;8(5):727-734. PMID: 28905498.
- Rooks D, Swan T, Goswami B, et al. Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020;3(10):e2020836. PMID: 33074327.
- Hofbauer LC, Witvrouw R, Varga Z, et al. 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. 2021;2(5):e263-e274. PMID: 36098133.
- Polkey MI, Praestgaard J, Berwick A, et al. Activin Type II Receptor Blockade for Treatment of Muscle Depletion in Chronic Obstructive Pulmonary Disease. A Randomized Trial. Am J Respir Crit Care Med. 2019;199(3):313-320. PMID: 30095981.
- Garito T, Roubenoff R, Hompesch M, et al. Bimagrumab improves body composition and insulin sensitivity in insulin-resistant individuals. Diabetes Obes Metab. 2018;20(1):94-102. PMID: 28643356.
- Garito T, Zakaria M, Papanicolaou DA, et al. Effects of bimagrumab, an activin receptor type II inhibitor, on pituitary neurohormonal axes. Clin Endocrinol (Oxf). 2018;88(6):908-919. PMID: 29566437.
- Heymsfield SB, Coleman LA, Miller R, et al. Effect of Bimagrumab vs Placebo on Body Fat Mass Among Adults With Type 2 Diabetes and Obesity: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2021;4(1):e2033457. PMID: 33439265. Errata: JAMA Netw Open. 2021;4(2):e211376 and 2021;4(3):e212581 (the second corrects the placebo group’s HbA1c change to +0.04 points).
- Rooks D, Petricoul O, Praestgaard J, Bartlett M, Laurent D, Roubenoff R. Safety and pharmacokinetics of bimagrumab in healthy older and obese adults with body composition changes in the older cohort. J Cachexia Sarcopenia Muscle. 2020;11(6):1525-1534. PMID: 33264516.
- Petricoul O, Nazarian A, Schuehly U, et al. Pharmacokinetics and Pharmacodynamics of Bimagrumab (BYM338). Clin Pharmacokinet. 2023;62(1):141-155. PMID: 36527600.
- Heymsfield SB, Aronne LJ, Montgomery P, et al.; BELIEVE trial investigators. Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial. Nat Med. 2026;32(3):869-882. PMID: 41772149.
- Rooks D, Yates DP, Neelakantham S, et al. Cardiac safety of chronic inhibition of the myostatin-activin pathway with bimagrumab in healthy older adults. J Clin Endocrinol Metab. 2026;111(9):2573-2582. PMID: 41873146.
- Nunn E, Jaiswal N, Gavin M, et al. Antibody blockade of activin type II receptors preserves skeletal muscle mass and enhances fat loss during GLP-1 receptor agonism. Mol Metab. 2024;80:101880. PMID: 38218536.
- Hatakeyama S, Summermatter S, Jourdain M, Melly S, Minetti GC, Lach-Trifilieff E. ActRII blockade protects mice from cancer cachexia and prolongs survival in the presence of anti-cancer treatments. Skelet Muscle. 2016;6:26. PMID: 27462398.
- Tankó LB, Goldhahn J, Varela A, et al. Does Activin Receptor Blockade by Bimagrumab (BYM338) Pose Detrimental Effects on Bone Healing in a Rat Fibula Osteotomy Model? Calcif Tissue Int. 2016;99(3):310-321. PMID: 27167138.
- Kanbay M, Siriopol D, Copur S, et al. Effect of Bimagrumab on body composition: a systematic review and meta-analysis. Aging Clin Exp Res. 2024;36(1):185. PMID: 39251484.
- Shao C, Lin H, Yu J, et al. Efficacy and Safety of Bimagrumab in Adults With Obesity and Metabolic Dysfunction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Diabetes Obes Metab. 2026;28(10):9433-9442. PMID: 42530342.
- Walpurgis K, Thomas A, Dellanna F, Schänzer W, Thevis M. Detection of the Human Anti-ActRII Antibody Bimagrumab in Serum by Means of Affinity Purification, Tryptic Digestion, and LC-HRMS. Proteomics Clin Appl. 2018;12(3):e1700120. PMID: 29226558.
- Lempesis IG, Dalamaga M. Obesity pharmacotherapy reimagined: The era of multi-receptor agonists and next-generation metabolic modulators, perspectives and controversies. Metabol Open. 2026;30:100463. PMID: 41948476.
- Jastreboff AM, Ryan DH, Bays HE, et al. Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity - A Phase 2 Trial. N Engl J Med. 2025;393(9):843-857. PMID: 40549887.
- Eli Lilly and Company; Versanis Bio. Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases. Press release (PR Newswire), July 14, 2023. prnewswire.com/news-releases/lilly-to-acquire-versanis-to-improve-patient-outcomes-in-cardiometabolic-diseases-301877184.html. Read September 29, 2026.
- Eli Lilly and Company. Lilly Completes Acquisition of Versanis Bio. Press release (PR Newswire), August 14, 2023. prnewswire.com/news-releases/lilly-completes-acquisition-of-versanis-bio-301899755.html. Read September 29, 2026.
- PubMed. Search for bimagrumab or BYM338 in title or abstract: 79 records, 17 with clinical-trial publication types. September 29, 2026.
- ClinicalTrials.gov. Search for “bimagrumab OR BYM338 OR LY3985863”: 18 studies (API v2), September 29, 2026.
- ClinicalTrials.gov. NCT01925209 and NCT02573467 (RESILIENT and its extension): intervention description, “a 150 mg/mL concentrate for solution for i.v. infusion.” Read September 29, 2026.
- ClinicalTrials.gov. NCT01433263 (bimagrumab in cachexia with non-small cell lung cancer or pancreatic adenocarcinoma, Novartis): posted results. Read September 29, 2026.
- ClinicalTrials.gov. NCT06643728, NCT06890611, NCT07030127 and NCT06901349 (Eli Lilly); NCT05933499 (Massachusetts General Hospital). Read September 29, 2026.
- World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026). S4.3, Agents preventing activin receptor IIB activation. wada-ama.org.
- FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated May 14, 2026. fda.gov/media/94155/download.
- 21 CFR 216.23. Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act. ecfr.gov, current as of September 25, 2026.
- FDA. Drugs@FDA data (api.fda.gov/drug/drugsfda.json) and drug labels (api.fda.gov/drug/label.json), and NLM DailyMed (dailymed.nlm.nih.gov): searches for “bimagrumab,” no records, September 29, 2026.
- FDA. Orphan Drug Designations and Approvals, record 369012: bimagrumab, designated June 18, 2012, treatment of inclusion body myositis, sponsor Novartis Pharmaceuticals Corp. accessdata.fda.gov/scripts/opdlisting/oopd/. Read September 29, 2026.
- FDA/NCATS Global Substance Registration System. Bimagrumab, UNII N15SW1DIV8. gsrs.ncats.nih.gov. Read September 29, 2026.
- Selleck Chemicals. Bimagrumab (Anti-ACVR2B), Cat. No. A2595, product page. selleckchem.com/products/bimagrumab-anti-acvr2b.html. Read September 29, 2026.
- Thermo Fisher Scientific. ACVR2B (Bimagrumab Biosimilar) Recombinant Human Monoclonal Antibody, Invitrogen MA5-41992, product page. thermofisher.com. Read September 29, 2026.
Last updated: September 29, 2026 | Profile authored by Kalios Peptides research team
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