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Last update 20 Oct 2025

Bimagrumab

Last update 20 Oct 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Bimagrumab (JAN/USAN/INN), BYM-338, LY3985863

Target

ACVR2A x ACVR2B

Action

modulators

Mechanism

ACVR2A modulators(activin A receptor type 2A modulators), ACVR2B modulators(Activin receptor type-2B modulators)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Obesity

Inactive Indication

CachexiaDiabetes Mellitus, Type 2Hip Fractures+ [7]

Originator Organization

MorphoSys AG

Active Organization

Eli Lilly & Co.

Inactive Organization

Novartis Pharmaceuticals Corp.

License Organization

Eli Lilly & Co.

Versanis Bio, Inc.

Novartis AG

Drug Highest PhasePhase 2

First Approval Date-

RegulationBreakthrough Therapy (United States), Orphan Drug (United States)

Structure/Sequence

Sequence Code 169647L

Source: *****

Sequence Code 169668H

Source: *****

Clinical Trials associated with Bimagrumab

NCT07030127

/ RecruitingPhase 1

A Phase 1, Participant- and Investigator-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Doses of LY3985863 in Healthy Chinese Participants

The purpose of this study is to evaluate how well LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

Start Date11 Aug 2025

Sponsor / Collaborator

Eli Lilly & Co.

NCT05933499

/ Not yet recruitingPhase 2IIT

Effect of Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults with Obesity

In adults with obesity seeking treatment, weight loss would ideally be composed almost exclusively of fat mass. However, loss of muscle mass and bone are unintentional consequences of weight loss, which has detrimental effects on health by lessening improvements in glucose and insulin levels, contributing to weight regain by reducing basal metabolic rate, and increasing the risk of falls, and fractures. Data in animals and humans suggest that bimagrumab, an investigational new drug for obesity that inhibits the activin type II receptor (ActRII) inhibitor, may build muscle and bone while resulting in a loss of fat mass. Semaglutide, which is FDA-approved for the treatment of obesity, results in loss of fat mass, but its effects on muscle and bone are less clear. The investigators hypothesize that in a randomized, placebo-controlled trial of 65 adults with obesity randomized to IV bimagrumab, identical IV placebo plus semaglutide, or identical IV placebo alone, bimagrumab will result in improvements in muscle, fat, and bone compared to semaglutide or placebo when given in addition to a lifestyle intervention for weight loss over 52 weeks.

Start Date01 Aug 2025

Sponsor / Collaborator

The Schwartz Center for Compassionate Healthcare

NCT06901349

/ WithdrawnPhase 2

A Phase 2b Double-Blind, Randomized, Placebo-Controlled Study of Bimagrumab and Tirzepatide, Alone or in Combination, to Investigate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes

The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.

Start Date23 May 2025

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Bimagrumab

100 Translational Medicine associated with Bimagrumab

100 Patents (Medical) associated with Bimagrumab

Literatures (Medical) associated with Bimagrumab

01 Dec 2025·Bone Reports

High-fat diet induced obesity and anti-activin receptor antibody: Effects on bone properties in mice

Article

Author: Bromer, Frederik Duch ; Andersen, Christian Brix Folsted ; Sylow, Lykke ; Brüel, Annemarie ; Carlsson, Michala ; Thomsen, Jesper Skovhus ; Lodberg, Andreas

Aim:

Weight-loss therapy often results in an unintended loss of muscle and bone mass. Inhibitors of the activin receptor signaling pathway, such as bimagrumab, an anti-activin receptor antibody (αActRIIA/IIB ab), are under investigation to counteract weight-loss induced muscle loss, but their skeletal effects in obesity remain unclear. This study investigates αActRIIA/IIB ab on bone in mice exposed to a high-fat diet (HFD) model of obesity or standard chow.

Materials and methods:

Male C57BL/6 J mice were stratified into four groups (n = 10/group, standard chow or HFD for 10 weeks ± αActRIIA/IIB ab). αActRIIA/IIB ab (10 mg/kg) was administered twice weekly during the final three weeks. The femur and vertebral body were assessed using DEXA, μCT, mechanical testing, and histomorphometry.

Results:

HFD did not affect bone density, microstructure, or strength but reduced histological bone formation markers. In standard chow mice, αActRIIA/IIB ab increased trabecular bone volume fraction (BV/TV) and volumetric bone mineral density (vBMD) by 36 %. In HFD mice, the effect of αActRIIA/IIB ab was less pronounced but still increased BV/TV (+16 %) and vBMD (+13 %). For cortical bone, μCT parameters remained largely unaffected by αActRIIA/IIB ab, while the treatment increased periosteal mineralizing bone surfaces in standard chow mice (+217 %), but not in HFD mice.

Conclusions:

αActRIIA/IIB ab enhanced trabecular bone properties in standard chow-fed mice, but its anabolic effects were blunted in HFD-fed mice. Furthermore, αActRIIA/IIB ab improved cortical histological bone formation markers, while morphology remained unaffected, suggesting a site- or time-specific difference. Thus, αActRIIA/IIB ab holds potential for mitigating weight-loss-associated bone deterioration.

01 Oct 2025·REVIEWS IN ENDOCRINE & METABOLIC DISORDERS

New drugs for the treatment of obesity: do we need approaches to preserve muscle mass?

Review

Author: Ryan, Donna H

The development of drugs targeting Nutrient Stimulated Hormone receptors has ushered in a dramatic change in our approach to weight management because of their ability to achieve weight losses of 10%, 20%, even 30% in significant numbers of patients. Additionally, disease modifying properties of these medications are compelling. Indications now include cardiovascular risk reduction, obstructive sleep apnea and diabetes management, and emerging evidence supports efficacy for heart failure and chronic kidney disease. These medications would need to be taken long term and the population being treated will be older than the traditional weight management patient. Emerging evidence cautions that the loss of excessive lean mass with some of the newer medications may be problematic. This is not a concern for most patients who will need the medications, but it is a concern in an older population, since loss of muscle and bone accelerates and progresses past age 60. Of weight lost with semaglutide, approximately 45% is from lean mass, while with tirzepatide, it is 25%. Going forward, combining another NuSH such as glucagon or amylin with the GLP-1 receptor agonists may lessen loss of lean mass. Another approach under study is the use of MAPi - myostatin-activin pathway inhibitors. Promising results with bimagrumab are spurring investigaton in this area. For the full potential of disease modification to be achieved, it's a given that we must demonstrate safe, long term body composition improvement when the new medications are deployed, especially in the older population. This narrative review discusses the justification for focus on lean mass preservation and reviews the status of relevant drugs in development.

01 Sep 2025·Drug Testing and Analysis

A Generic Detection Method for the Doping Control Analysis of Fc‐Fusion Proteins and Monoclonal Antibodies in Equine Plasma

Article

Author: Wan, Terence S. M. ; So, Yat‐Ming ; Choi, Yung‐Ching ; Wong, Kin‐Sing ; Bond, Amanda J. ; Cheung, Hiu Wing ; Kwok, Wai Him ; Farrington, Adrian F. ; Ho, Emmie N. M.

ABSTRACT:

An increasing number of novel Fc‐fusion proteins and monoclonal antibodies (mAbs) are being developed as therapeutic agents for treating various diseases. Among these, there are inhibitors of the activin Type II receptor (ActRIIA and ActRIIB) signaling pathways and mAbs against nerve growth factor (NGF), which may be misused for performance enhancement in horseracing and equestrian sports. This study is aimed at developing a generic detection method for doping control analysis of nine targeted proteins, each containing the Fc domain of human IgG or IgG from other species in equine plasma, namely, three recombinant Fc‐fusion proteins (sotatercept, follistatin‐Fc (FST‐Fc), and erythropoietin‐Fc (EPO‐Fc)) and six mAbs (bimagrumab, domagrozumab, garetosmab, landogrozumab, bedinvetmab (Librela), and frunevetmab (Solensia)). A generic workflow has been developed, involving affinity purification with commercially available Protein A magnetic beads followed by tryptic digestion and detection of 20 targeted peptides (with 2–3 diagnostic peptides for each targeted protein) using capillary flow high‐performance liquid chromatography–high‐resolution tandem mass spectrometry (HPLC‐HRMS). The method identified all nine targeted proteins in spiked equine plasma with adequate sensitivity and precision, and for the first time, bedinvetmab (Librela) was detected and identified in plasma for at least 34 days after a single subcutaneous administration (0.5 mg/kg) to a Thoroughbred horse. The results have demonstrated the method's applicability to equine doping control. This generic method involving affinity purification by Protein A has provided a pragmatic and effective approach to cope with the doping control of novel Fc domain–containing proteins.

News (Medical) associated with Bimagrumab

25 Sep 2025

·www.fiercebiotech.com

Eli Lilly withdraws phase 2b trial of $1.9B obesity bet before starting enrollment

A phase 2 trial of bimagrumab and tirzepatide in patients without diabetes is continuing to enroll, per ClinicalTrials.gov.\n Eli Lilly has pulled the plug on a phase 2b obesity trial before enrolling a single patient, citing “strategic business reasons.” The study was designed to test bimagrumab, an asset Lilly acquired in its $1.9 billion Versanis buyout, as a single agent and in combination with blockbuster GLP-1/GIP drug tirzepatide.Lilly filed to run the study in March. At that time, the company was planning to enroll 180 people with obesity or who are overweight plus Type 2 diabetes to test the effects of bimagrumab, an antibody that binds activin type II A and B receptors to block activin and myostatin signaling. The study featured nine arms to test various regimens of bimagrumab and tirzepatide, the active ingredient in Mounjaro and Zepbound. However, as first reported by Bloomberg News, Lilly has axed the trial. An early sign that something was amiss emerged in June, when the company changed the status of the study on ClinicalTrials.gov from “not yet recruiting” to “active, not recruiting.”Lilly changed the trial’s status again, this time to “withdrawn,” in an update that went live Wednesday. To explain the update, the company said the trial was terminated for strategic business reasons. Lilly told Fierce Biotech in a short, emailed statement that it “routinely evaluate(s) our clinical development programs to optimize the potential for each product.”The pharma added that bimagrumab is still “currently being studied in an ongoing phase 2 trial with tirzepatide, alone or in combination, in patients with obesity. Results from this trial will be available in 2026.” The first change to the status of the withdrawn trial coincided with the publication of data from a phase 2 study that tested bimagrumab in combination with semaglutide, the GLP-1 drug Novo Nordisk sells as Ozempic and Wegovy. In a presentation at the American Diabetes Association’s Scientific Sessions in June, researchers hailed a “very striking difference” in the proportion of weight loss from fat in the combination arm. Fat accounted for around 72% of weight loss in patients who took semaglutide as a monotherapy. The figure jumped to above 90% in the combination cohort. Versanis began the semaglutide combination trial and tested an intravenous version of bimagrumab. Lilly switched to subcutaneous dosing for its trials of bimagrumab and swapped out Novo’s semaglutide for its own tirzepatide.Editor\'s note: This story was updated at 10:40 a.m. ET to include comment from Lilly.

Phase 2

25 Sep 2025

·endpoints.news

Kardigan gets the rights to a MyoKardia drug; Lilly stops Phase 2 trial for muscle-sparing candidate

Plus, news about uniQure, MBX Biosciences, KalVista, Volastra, Basilea Pharmaceutica, Gossamer Bio, Respira Therapeutics, Sanofi, Immuneering and Heidelberg Pharma: 🫀 Kardigan reveals its pipeline: The cardiovascular biotech has in-licensed three clinical-stage assets for undisclosed terms, including Ionis’ tonlamarsen and Sanofi’s ataciguat , according to past Endpoints News reports. Kardigan is now saying it also got the exclusive worldwide rights to danicamtiv, which was discovered by MyoKardia, the cardio company acquired by Bristol Myers Squibb. Tassos Gianakakos, who is Kardigan’s CEO, previously was the chief executive of MyoKardia, steering the company to a $13 billion exit in 2020. Kardigan emerged with $300 million in January . — Kyle LaHucik 💉 Eli Lilly halts muscle-sparing diabetes study: The drugmaker called off a Phase 2 trial of its muscle-building product bimagrumab in combination with its obesity shot Zepbound, according to the federal clinical trials register. The trial intended to enroll patients with both obesity and type 2 diabetes, but Lilly terminated it for “strategic business reasons.” A spokesperson said the company routinely evaluates its clinical development programs “to optimize the potential for each product.” Another mid-stage trial of bimagrumab in nondiabetic obesity patients, again in combination with Zepbound, could report in the second quarter of next year. The activin/myostatin type II inhibitor has already shown promise in Phase 2 when used alongside Novo Nordisk’s GLP-1 Wegovy. — Elizabeth Cairns 💰 UniQure launches $200M offering: The company set out to raise the money after reporting new positive data from its Huntington’s disease gene therapy. UniQure shares $QURE were up nearly 250% at market close on Wednesday. — Max Gelman 📈 MBX Biosciences’ $199M offering: The company is selling about 11.1 million shares at $18 apiece. Earlier this week, MBX disclosed Phase 2 data for its experimental hypoparathyroidism treatment. — Jaimy Lee 📝 KalVista’s $125M offering: The company plans to use the proceeds from the offering of convertible senior notes to fund the commercialization of Ekterly , its newly approved hereditary angioedema drug. — Jaimy Lee 💵 Volastra adds $30M to Series A: The New York biotech reeled in the additional funds from “all key existing investors,” a Volastra spokesperson told Endpoints News , confirming the details of an SEC filing . The startup in 2023 disclosed a $60 million Series A from Polaris, ARCH Venture Partners and Eli Lilly, among others. The cancer biotech in May presented data on its KIF18A inhibitor VLS-1488. It also has the rights to an Amgen oncology drug. — Kyle LaHucik 💊 Basilea Pharmaceutica’s new government funding: The company has been awarded a BARDA contract to advance a Phase 3 oral antibiotic for complicated urinary tract infections. Basilea recently acquired the global rights to the antibiotic, which is called ceftibuten-ledaborbactam etzadroxil, from Venatorx. It’s getting $6 million upfront, with up to $153 million in milestones on the table. — Anna Brown 🏦 Gossamer Bio to acquire Respira Therapeutics in all-stock deal: The buyout will net Gossamer a program called RT234, which is being studied for pulmonary hypertension. RT234 is an inhaled version of the generic drug vardenafil, a PDE5 inhibitor. Gossamer plans to seek an approval through the 505(b)(2) regulatory pathway, though it may not start new clinical trials until 2027. Gossamer’s stock $GOSS was down about 7% on Thursday morning. — Max Gelman 💸 Sanofi invests $25M in Immuneering: The French drugmaker purchased $25 million worth of Immuneering’s stock as part of a public offering. Immuneering on Wednesday reported additional positive data for its experimental pancreatic cancer drug. It intends to use the money from the offering on preclinical and clinical studies. — Max Gelman 💼 Heidelberg Pharma is laying off 75% of its staff: The German biotech said it hasn’t yet received $70 million for a milestone stemming from a deal with HealthCare Royalty, saying the “condition had not been met.” To conserve cash, it will now focus on developing its antibody-drug conjugate HDP-101, and it’s pausing work on another one called HDP-102 and discontinuing all early research. Heidelberg has 116 employees at the end of 2024. It had €22.9 million in cash as of Aug. 31. — Jaimy Lee

AcquisitionPhase 3Phase 2

25 Sep 2025

·www.biopharmadive.com

Lilly stops trial of muscle-sparing obesity drug

Dive Brief:Eli Lilly has canceled one clinical trial of an experimental muscle-sparing obesity drug, citing strategic business reasons, according to a federal database.The study was one of two Phase 2 trials testing the drug, known as bimagrumab, alone or with Lillys marketed medicine in people with obesity. The now-halted study included Type 2 diabetics as well.In an email to BioPharma Dive, a Lilly spokesperson said company executives routinely evaluate our clinical development programs to optimize the potential for each product and noted that a separate trial involving non-diabetic people with obesity is still underway. The trial stoppage was first reported by Bloomberg.Bimagrumab is among the drugs designed to preserve muscle in people taking weight loss drugs like Zepbound and Novo Nordisks Wegovy, which can cut lean mass as well as fat. But at least one biotech has said that additive weight loss effects are an approval requirement, suggesting higher clearance standards have been established by the Food and Drug Administration.Dive Insight:Lilly, Novo Nordisk and the companies chasing them all want to build on the success of Zepbound and Wegovy with newer medicines that can address their limitations. Among those weaknesses are the loss of muscle that can occur in people taking obesity drugs, in part because a suppressed appetite and slower digestion leads them to consume less protein.Medicines like bimagrumab, which target proteins that regulate muscle growth, are one potential solution. The hope is these drugs might protect muscle without interfering with the weight loss GLP-1 drugs are known for.In addition to Lilly, Regeneron Pharmaceuticals, Biohaven, Scholar Rock and Verualso have muscle-sparing obesity drugs in development.Bimagrumab was originally discovered by Novartis and tested against rare muscle-wasting conditions like sarcopenia and inclusion body myositis. Novartis licensed itto biotech startup Versanis Bio, which launched in 2021 and envisioned it as part of obesity drug regimens.Lilly bought Versanisfor up to $1.9 billion two years later.The trial Lilly terminated was expected to enroll 180 people and finish in late 2026. The still-active studyis listed in a federal database as recruiting patients who are receiving a placebo or several different dosing regimens of bimagrumab with or without Zepbound. Its measuring how well the regimens stimulate weight loss and preserve muscle mass. Initial results are expected around April 2026, according to the database.The study stoppage comes as the FDA appears to be indicating that drugs like bimagrumab may need to do more than just improve muscle composition. Veru earlier this week said the agency now guides that incremental weight loss over a GLP-1 drug alone is an acceptable primary endpoint to support approval. Verus shares fell 3% on Tuesday following that announcement, and another 3% Thursday. '

Phase 2Acquisition

100 Deals associated with Bimagrumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10620	Bimagrumab	-	DB12584

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myositis, Inclusion Body	Phase 3	United States	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	Japan	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	Australia	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	Denmark	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	France	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	Italy	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	Netherlands	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	Switzerland	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	United Kingdom	Novartis Pharmaceuticals Corp.	02 Nov 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05616013 (OR10-03, CTgov)	Phase 2	Overweight \| Obesity	507	Placebo (Placebo)	mtoaupcszt(ncmemdukzj) = wpthukquca clcormjhqk (qiqngruvcc, 1.39) View more	-	18 Jul 2025
				Bimagrumab (Bimagrumab 10 mg/kg)	mtoaupcszt(ncmemdukzj) = zxsnbecncx clcormjhqk (qiqngruvcc, 1.42) View more
BELIEVE (NEWS 1 \| NEWS 2) Manual	Phase 2	Overweight \| Obesity	507	Bimagrumab	rullilvtjc(wliohqlplj) = yyqwcofwzd bzwhvicxlh (lafwxkqsea ) View more	Positive	23 Jun 2025
				Semaglutide	rullilvtjc(wliohqlplj) = rmztpqiwpf bzwhvicxlh (lafwxkqsea ) View more
SO 52 (EASD2023)	Phase 1/2	Weight Loss \| Muscular Atrophy	-	Bimagrumab 3 mg/kg	dqtegnjxvx(xomsxtjahc) = nzxfirmzdg gkkuuxkkhv (lulgfprdpt )	Positive	04 Oct 2023
				Bimagrumab 10 mg/kg	mviwpdvawb(ciqyswyegc) = vzkvfeyrcp scqxnnzqie (nnhvmvwftp )
NCT05616013 (ADA2023)	Phase 2	Weight Loss	75	Bimagrumab 10 mg/kg IV	idcruxxgwr(jncwxkcxdt) = gxlhtcpbej iaypndsrfu (xflfkegytd ) View more	-	20 Jun 2023
				Placebo	idcruxxgwr(jncwxkcxdt) = xefqxvzcfc iaypndsrfu (xflfkegytd ) View more
PRNewswire Manual	Phase 2	Diabetes Mellitus	569	Bimagrumab	ffkfsdrzfu(ohlkmunied) = etjtzcdiah yffpaommef (ecjxjmasdr )	Positive	11 Jun 2022
				Placebo	ffkfsdrzfu(ohlkmunied) = tlcrgetykv yffpaommef (ecjxjmasdr )
NCT02573467 (RESILIENT, Pubmed) Manual	Phase 3	Myositis, Inclusion Body	211	Bimagrumab	twwjkkzlch(qqdkmzzyfh) = rjrgagmrre asqmkgqagw (bwdmeudsrn ) View more	Negative	23 Mar 2021
				Placebo	twwjkkzlch(qqdkmzzyfh) = ktilfqkwro asqmkgqagw (bwdmeudsrn ) View more
NCT03005288 (Pubmed \| JAMA Netw Open) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	75	Bimagrumab	smddvmkxkl(rljwgfnopk) = kkisbfpxqx zcenexinbi (jqodswtyrr, -8.3 to -6.6) View more	Positive	04 Jan 2021
				Placebo	smddvmkxkl(rljwgfnopk) = ojvicuauin zcenexinbi (jqodswtyrr, -0.99 to 0.63) View more
NCT02250443 (Pubmed \| Ann Neurol \| Neurology) Manual	Phase 2/3	Myositis, Inclusion Body	10	Bimagrumab	bzolxcdoxi(tbymkjoqmw) = muscle spasms and falls (both 9 of 10, 90%),diarrhea (6 of 10, 60%) and acne and skin eruption (both 5 of 10, 50%) yehibwhbdv (qsmlsewbdu )	Negative	06 Oct 2020
NCT02333331 (Pubmed \| JAMA Netw Open) Manual	Phase 2	Sarcopenia	180	SOC+Bimagrumab	ynfbzlslaa(fszuivqwyt) = rsnfmikndu lzkfqgwhhq (pormyktqey, 0.90 - 1.77) View more	Positive	01 Oct 2020
				SOC+Placebo	ynfbzlslaa(fszuivqwyt) = pzvprbpjyi lzkfqgwhhq (pormyktqey, 0.53 - 1.52) View more
NCT03005288 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	78	BYM338 10 mg/kg (BYM338 10 mg/kg)	fabkyrtlpd(bgflsioiqg) = pjvivdwurz hjtyzoujfv (enrhuugmyq, jfvhrfnvdi - uvnovsstuc) View more	-	04 Jun 2020
				Placebo (Placebo)	fabkyrtlpd(bgflsioiqg) = bovkugyfef hjtyzoujfv (enrhuugmyq, rzzywsqdcq - lqpguyrfsx) View more

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