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Studien
Bim3.9
Bimagrumab – Forschung
Überwiegend Mechanismus / Beobachtung
20 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Bimagrumab sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus hochwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2014–2026 mit einer typischen Studiengröße von 251 Teilnehmenden.
Basierend auf 20 Studien · 2 Meta-Analysen · 5 RCTs · 2,543 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Muscle & lean massPilot-Studie zu sIBM: Eine Einzeldosis steigerte das Oberschenkelmuskelvolumen um ~6,5 % und die Magermasse um ~5,7 % gegenüber Placebo (Evidenz der Klasse I, dass eine ActRII-Blockade beim Menschen Muskulatur aufbaut) · Innerhalb von 8-16 Wochen
Überwiegend Mechanismus / Beobachtung14 Studien
Fat loss & metabolic
Überwiegend Mechanismus / Beobachtung9 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung8 Studien
Aktives Forschungsgebiet
17 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2025
201420202026
1RCTn=507 · large study2026
ClinicalTrials.gov identifier: NCT05616013 .
Heymsfield SB, Aronne LJ, Montgomery P, Klickstein LB, Coleman LA, Dole K, Mindeholm L, Spruill S, Li X, Attie KM, BELIEVE trial investigators. · Nature medicine (2026)
The least squares mean absolute changes in body weight at week 48 were -9.3 kg (bimagrumab 30 mg kg -1 ), -14.2 kg (semaglutide 2.4 mg) and -17.8 kg (bimagrumab 30 mg kg -1 plus semaglutide 2.4 mg-that is, high-dose combination) versus -3.3 kg (placebo) (all P < 0.001 versus placebo).
Continued improvements were observed through week 72.
Common adverse events for bimagrumab included muscle spasms, diarrhea and acne, and semaglutide was associated with nausea, diarrhea, constipation and fatigue.
Future efforts must focus on harmonizing diagnostic criteria, refining therapeutic regimens, and leveraging emerging technologies to develop targeted interventions that preserve muscle function and enhance quality of life in the aging population.
Jeyaraman M, Jeyaraman N, Nallakumarasamy A, Ramasubramanian S, Muthu S, Murugan S, Rajendran SNS, Rajendran RL, Ahn BC, Gangadaran P. · Molecular imaging and biology (2026)
Integration of these approaches with personalized medicine paradigms and AI-driven diagnostic tools holds promise for improved outcomes.
This review also outlines critical research areas including mechanistic studies, diagnostic standardization, and translational gaps between preclinical models and clinical application.
Addressing these challenges requires an interdisciplinary strategy that encompasses molecular, clinical, and public health perspectives to mitigate the personal and societal impacts of sarcopenia.
Preliminary findings are promising, but larger, controlled trials are necessary to confirm efficacy and safety before clinical implementation can be considered.
Integrating skeletal muscle preservation into obesity management may optimize functional, metabolic, and clinical outcomes, representing a paradigm shift in comprehensive care.
Lisco G, De Tullio A, Disoteo OE, Dicorato P, Tortora A, De Geronimo V, Triggiani V. · Reviews in endocrine & metabolic disorders (2026)
Activin receptor (IIA/IIB) blockade prevents the small mothers against decapentaplegic homolog 2/3-mediated muscle catabolism, promoting myofibrillar synthesis, myoblast differentiation, and hypertrophy.
Bimagrumab - a human anti-activin receptor antibody - consistently increases skeletal muscle mass and improves body composition across populations, including sarcopenic adults, patients with disuse atrophy, and individuals with obesity.
While gains in strength are variable, this approach represents a promising adjunct to lifestyle and pharmacologic interventions.
Combined interventions appear promising in some studies, but future evaluations may focus on combinations of physical activity and exercise with new pharmaceutical approaches like Semaglutide or Bimagrumab medication in the long term for military personnel due to probable favorable body composition adaptations and military readiness.
Scheit L, Baustert L, Schröder J. · Journal of occupational medicine and toxicology (London, England) (2025)
Where possible, the effect size (ES) was calculated.
Results In studies that only examined exercise, minor effects were reported, e.g. a reduction in weight (-0.5 kg), Body Mass Index (BMI) (-0.3 kg/m²), waist circumference (-0.1 cm) and body fat percentage (-1.1%) without relevant statistical ES.
Combined programs with exercise and educational methods showed a moderate to large effect size (ES 0.6-1.3) for weight reduction.
Future directions will focus on integrating AI into clinical trials to refine and personalize obesity management strategies.
Al Lawati A, Alhabsi A, Rahul R, Savino ML, Alwahaibi H, Das S, Al Lawati H. · Diseases (Basel, Switzerland) (2025)
Artificial intelligence presents intriguing opportunities to enhance weight loss strategies; however, its integration into clinical practice remains investigational and requires rigorous clinical validation.
While current anti-obesity medications deliver significant benefits, future research must determine the efficacy, safety, and cost-effectiveness of AI-driven approaches.
This includes exploring how AI can complement combination therapies and tailor personalized interventions, thereby grounding its potential benefits in robust clinical evidence.
Ultimately, this will help establish a comprehensive and precise multi-level intervention framework to improve patient outcomes.
Zhang X, Wang Z, Wang J, Wu F, Xia L, Shi S, Zhu M, Zhuang J. · Journal of multidisciplinary healthcare (2025)
Currently, early diagnosis remains the critical barrier.
This review aims to synthesize the latest evidence on the risk factors, diagnostic challenges, and management strategies for ICU-AW, providing insights for clinical practice.
It also underscores the need for future research to focus on developing highly sensitive diagnostic tools, optimizing preventive strategies, and promoting the clinical translation of targeted therapies.
Future research should prioritize multimodal therapies, validated biomarkers, and AI-driven algorithms to individualize sarcopenia management in aging populations.
Liu X, Chen X, Cui J. · Clinical nutrition (Edinburgh, Scotland) (2025)
Sarcopenia, a progressive decline in skeletal muscle mass and function, has emerged as a critical geriatric syndrome affecting 10-40% of older adults, contributing to increased disability and mortality.
Pharmacological trials highlight selective androgen receptor modulators (SARMs) and myostatin inhibitors (e.g., bimagrumab) increasing lean mass by 3-5% in phase II studies, with GDF-15-neutralizing antibodies emerging as promising anti-catabolic agents.
However, clinical translation requires validation through large-scale trials.
This narrative review discusses the justification for focus on lean mass preservation and reviews the status of relevant drugs in development.
Ryan DH. · Reviews in endocrine & metabolic disorders (2025)
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.
Of weight lost with semaglutide, approximately 45% is from lean mass, while with tirzepatide, it is 25%.
Another approach under study is the use of MAPi - myostatin-activin pathway inhibitors.
Further research is needed to assess the long-term effects of GLP-1 RA on muscle health and to refine strategies to prevent sarcopenia in patients undergoing pharmacological weight loss.
Chavez AM, Carrasco Barria R, León-Sanz M. · Current opinion in clinical nutrition and metabolic care (2025)
Recent findings Studies have shown that while GLP-1 RA are effective in reducing fat mass, up to 40% of the total weight loss can come from FFM.
If these measures are insufficient to prevent and maintain muscle mass, the use of some nutrients, such as branched chain amino acids, creatine, leucine, omega-3 fatty acids and vitamin D, may be beneficial.
Newer pharmacological approaches, such as bimagrumab, a human monoclonal antibody that acts by binding to the activin type II receptor II (ActRII), and other activin or myostatin inhibitors, show promise in preserving muscle mass while promoting fat loss.
This review aims to provide a reference for the field of mechanism research in osteosarcopenia and offer new insights for its precision prevention and treatment.
Pu Y, Teng Y, Li Y, Zhou Y, Gao M, Yan Z, Teng Z. · Frontiers in physiology (2025)
This review aims to construct a hierarchical framework of "intracellular - intercellular - systemic" to systematically elaborate on the pathogenesis of osteosarcopenia.
Based on this foundation, it explores frontier interventions and their prospects for clinical transformation, including bone-targeting F6-(DSS)6-exo nanoparticles, miR-495, natural active compounds (resveratrol, nuciferine), Clostridium butyricum, and bimagrumab.
Future research should focus on analyzing the microenvironment of the musculoskeletal interface, utilizing deep learning CT analysis for early risk identification, and exploring the application of biomaterials in osteomuscular regeneration.
These observations suggest that bimagrumab might represent a new approach for treating patients with obesity and related metabolic disturbances.
Kaur M, Misra S. · Journal of basic and clinical physiology and pharmacology (2024)
The trial involved [number of participants], and the results showed [specific findings].
Currently, Bimagrumab is being evaluated for its potential to treat muscle wasting, functional loss in hip fractures and sarcopenia, as well as obesity.
However, it is essential to note that Bimagrumab also blocks the effects of other ActRII ligands, which play a role in the neurohormonal axes, pituitary, gonads, and adrenal glands.
Further research is needed to clarify its long-term efficacy, optimal dosing regimens, and potential benefits for specific subgroups of sarcopenic patients.
Kanbay M, Siriopol D, Copur S, Hasbal NB, Güldan M, Kalantar-Zadeh K, Garfias-Veitl T, von Haehling S. · Aging clinical and experimental research (2024)
However, no significant improvement was observed in muscle strength or physical performance measures such as gait speed and six-minute walk distance with bimagrumab treatment, except among participants with slower baseline walking speeds or distances.
Discussion and conclusion This meta-analysis provides valuable insights into the effects of bimagrumab on sarcopenic patients, highlighting its significant improvements in body composition parameters but limited impact on functional outcomes.
The observed heterogeneity in outcomes across studies underscores the need for cautious interpretation, considering variations in study populations, treatment durations, and outcome assessments.
For the time being, considerations like advanced age and prefrailty may affect the choice of suitable candidates in clinical practice for current and emerging anti-obesity medications due to the associated risk of sarcopenia.
Stefanakis K, Kokkorakis M, Mantzoros CS. · Metabolism: clinical and experimental (2024)
Similar to bariatric surgery, incretin receptor agonists have revolutionized the treatment of obesity, achieving up to 15-25 % weight loss in many patients, i.e., at a rate approaching that achieved with bariatric surgery.
However, over 25 % of total weight lost from both surgery and pharmacotherapy typically comes from fat-free mass, including skeletal muscle mass, which is often overlooked and can impair metabolic health and increase the risk of subsequent sarcopenic obesity.
Novel compounds in the pipeline, such as Bimagrumab, Trevogrumab, and Garetosmab-which inhibit activin and myostatin signaling-have demonstrated promise in preventing muscle loss while promoting fat loss.
In this review, we present the efficacy and safety data for the pipeline of obesity pharmacotherapies with a focus on entero-pancreatic hormone-based treatments and we consider the clinical implications and challenges that the new era in obesity management may bring.
Melson E, Ashraf U, Papamargaritis D, Davies MJ. · International journal of obesity (2005) (2025)
Semaglutide 2.4 mg once weekly, a subcutaneously administered GLP-1 RA approved for obesity treatment in 2021, results in 15-17% mean weight loss (WL) with evidence of cardioprotection.
Tirzepatide, a dual GLP-1/GIP receptor agonist has been approved for glycaemic control in type 2 diabetes as well as for obesity management leading in up to 22.5% WL in phase 3 obesity trials.
Other combinations of entero-pancreatic hormones including cagrisema (GLP-1/amylin RA) and the triple agonist retatrutide (GLP-1/GIP/glucagon RA) have also progressed to phase 3 trials as obesity treatments and early data suggests that may lead to even greater WL than tirzepatide.
At week 52, 6MWD change from baseline did not differ between any bimagrumab dose and placebo (least squares mean treatment difference for bimagrumab 10 mg/kg group, 17·6 m... p=0·22).
Hanna MG, Badrising UA, Benveniste O, Lloyd TE, Needham M, Chinoy H, Aoki M, Machado PM, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM. · Lancet Neurol (2019)
The load-bearing counter-evidence: the pivotal phase 2b RESILIENT trial randomized 251 inclusion-body-myositis patients across 38 sites to bimagrumab (1, 3, or 10 mg/kg) or placebo, IV every 4 weeks, with 6-minute walking distance at 52 weeks as the primary endpoint
FAILED its primary endpoint — 6MWD did not differ from placebo at any dose (10 mg/kg difference 17.6 m, p=0.22), despite the drug's known muscle-mass effect
Muscle spasms (40-68%) and diarrhoea (32-52%) were the most frequent adverse events with bimagrumab; falls were common across all groups (a feature of the disease)
ActRII blockade with bimagrumab led to significant loss of FM, gain in LM, and metabolic improvements during 48 weeks in patients with overweight or obesity who had type 2 diabetes.
Heymsfield SB, Coleman LA, Miller R, Rooks DS, Laurent D, Petricoul O, Praestgaard J, Swan T, Wade T, Perry RG, Goodpaster BH, Roubenoff R. · JAMA Netw Open (2021)
The headline metabolic trial: a double-masked, placebo-controlled, 48-week phase 2 RCT in 75 adults with type 2 diabetes and obesity, given monthly intravenous bimagrumab (10 mg/kg, up to 1200 mg) or placebo plus diet/exercise counselling
Bimagrumab produced a large loss of total body fat mass (~20.5% relative reduction) and a gain in lean mass (~3.6%) versus placebo at week 48 — a striking fat-down/lean-up body recomposition
Also reduced waist circumference and body weight (-6.5%) and improved HbA1c versus placebo; safety/tolerability was consistent with prior studies
Trials of methotrexate... bimagrumab, arimoclomol, and sirolimus provided low-quality to high-quality evidence of having no effect on the progression of IBM.
Santos EJF, Farisogullari B, Yapp N, Townsley H, Sousa P, Machado PM. · RMD Open (2025)
Top-of-pyramid synthesis: a Cochrane-method systematic review (with meta-analysis where possible) of randomized trials of pharmacological treatments for inclusion-body myositis
Concluded that the trialed drugs — including bimagrumab — showed evidence of having no effect on the progression of IBM
Reinforces the RESILIENT result at the synthesis level: no IBM drug, bimagrumab included, has been shown to change disease course
Eight weeks after dosing, the bimagrumab-treated patients increased thigh muscle volume (right leg +6.5% compared with placebo, p = 0.024)... and lean body mass (+5.7% compared with placebo, p = 0.014).
Amato AA, Sivakumar K, Goyal N, David WS, Salajegheh M, Praestgaard J, Lach-Trifilieff E, Trendelenburg AU, Laurent D, Glass DJ, Roubenoff R, Tseng BS, Greenberg SA. · Neurology (2014)
The proof-of-concept human trial: a randomized controlled pilot in 14 sporadic inclusion-body-myositis patients given a single dose of bimagrumab (n=11) or placebo (n=3), with thigh-muscle volume by MRI at 8 weeks as the primary outcome
Bimagrumab increased thigh-muscle volume (+6.5% right, +7.6% left) and lean body mass (+5.7%) versus placebo, and 6-minute walking distance improved, peaking at +14.6% at 16 weeks (p=0.008)
Established that ActRII blockade builds muscle in humans (Class I evidence); the main adverse events were mild acne and transient involuntary muscle contractions
Bimagrumab alters the function of pituitary gonadotroph cells, consistent with blockade of activin on local ActRII. This effect is reversible with clearance of bimagrumab.
Garito T, Zakaria M, Papanicolaou DA, Li Y, Pinot P, Petricoul O, Laurent D, Rooks D, Rondon JC, Roubenoff R. · Clin Endocrinol (Oxf) (2018)
Mechanistic/safety RCT: healthy adults aged 55-75 received IV bimagrumab 10 mg/kg or placebo, with pituitary-gonadal and pituitary-adrenal function assessed by GnRH and ACTH stimulation tests
In women, FSH levels were reduced by 42.16 IU/L (P<.001) and LH increased, consistent with blockade of activin signalling at the pituitary; effects were reversible after the antibody cleared
Gonadal and adrenal androgen levels were not affected — the neurohormonal effect was specific to the gonadotroph FSH/LH axis and transient