Latest news with #bimagrumab
Medscape
24-06-2025
- Health
- Medscape
Combination Treatment Reduces Weight While Keeping Muscle
CHICAGO — Combined use of semaglutide with an investigational monoclonal antibody called bimagrumab produced significant fat mass loss while preserving lean mass, results from the phase 2b BELIEVE study found. Loss of muscle mass is an emerging concern with increasing use of GLP-1 agonists for weight loss as lean body mass is estimated to account for up to 15%-40% of total weight loss from GLP-1 drugs. One potential solution is bimagrumab, which blocks the activin pathways that inhibit growth in skeletal muscle and increases lipid storage in adipose tissue, leading to both increased muscle mass and decreased fat mass. 'We're presenting an entirely new mechanism for managing obesity. We've heard a lot about GLP-1s and their combinations. This is going to be a unique one with bimagrumab, a drug that has completely different mechanism of action,' study investigator Steven B. Heymsfield, MD, professor and director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center of the Louisiana State University System, Baton Rouge, told Medscape Medical News . Results from the study comparing bimagrumab and semaglutide alone and in combination for treating obesity were presented on June 23, 2025, here at the American Diabetes Association 85th Scientific Sessions. Bimagrumab's effects are complementary to those of GLP-1 drugs and other appetite suppressants, explained co-investigator Louis J. Aronne, MD, professor of metabolic research and director of the Comprehensive Weight Control Center at Weill-Cornell Medical College, New York, at a press briefing. As such, he added, the drug's potential uses include being an adjunct to GLP-1 agonists for obesity induction therapy as an alternative to incretins for people who can't tolerate them or who don't respond adequately, and as a potential preferred maintenance therap. Fat Mass vs Muscle Mass The BELIEVE study was a randomized, double-blind, placebo-controlled, multicenter study in 507 adults with obesity or overweight. Participants were randomized into a total of nine groups: placebo; bimagrumab alone at doses of 10 mg/kg and 30 mg/kg; semaglutide 1.0 mg or 2.4 mg plus placebo; and one of four groups of combined bimagrumab and semaglutide — bimagrumab 10 mg/kg plus semaglutide 1 mg; bimagrumab 30 mg/kg plus semaglutide 1 mg; bimagrumab 10 mg/kg plus semaglutide 2.4 mg; or bimagrumab 30 mg/kg plus semaglutide 2.4 mg. Bimagrumab was given intravenously at weeks 4, 16, 28, and 40; subcutaneous semaglutide was given weekly. The primary treatment period was 48 weeks, followed by an open-label extension to 72 weeks with both the placebo and bimagrumab 10 mg/kg groups switching to bimagrumab 30 mg/kg. Body composition was assessed with DEXA. At week 72, body weight was reduced by 22.1% from baseline in the combined bimagrumab 30 mg/kg plus semaglutide 2.4 mg group (highest of both doses), compared with reductions of 15.7% with semaglutide 2.4 mg alone and 10.8% with bimagrumab 30 mg/kg alone. Loss of fat mass was 45.7% with the high-dose combination vs 27.8% with semaglutide 2.4 mg and 28.5% with bimagrumab 30 mg/kg alone. Lean mass loss was 2.9% with the high-dose combination, compared with a loss of 7.4% with semaglutide 2.4 mg and a gain of 2.5% with bimagrumab 30 mg/kg alone. The percentage of weight loss that was due to fat mass at week 48 was 92.9% for the high-dose combination, 71.5% for semaglutide alone, and 100% for bimagrumab alone. The proportions of participants achieving weight loss of 20% or more were 69.8% with the combination versus 25.0% with semaglutide, and 10.9% with bimagrumab. And, the proportions achieving 30% or greater fat mass reduction were 94.0%, 36.4%, and 50.0%, respectively, Heymsfield reported. Visceral adipose tissue decreased more with bimagrumab alone or in combination compared with semaglutide alone, with parallel changes from baseline in waist circumference. High-sensitivity C-reactive protein, a key inflammatory biomarker, decreased by 83% in the high-dose combination group by week 48, Aronne said. Adiponectin also increased more with bimagrumab alone or in combination compared with semaglutide alone. Both total and LDL cholesterol rose in the bimagrumab groups and then returned to baseline in the combination groups containing semaglutide 2.4 mg by week 72. Baseline LDL was 114.3 mg/dL, rising by about 15%-30% in the bimagrumab groups by 12-24 weeks. The combination groups returned to baseline by 72 weeks, whereas the bimagrumab-only group dropped, but not back to baseline. When asked about that, Aronne said 'We believe that the route of administration might be a reason for that observation. I think we need more research to figure this out.' Increased LDL Cholesterol: Is It a Concern? Asked to comment, Simeon Taylor, MD, PhD, professor of medicine and director of the Institutional Research Training Program in Diabetes & Obesity at the University of Maryland School of Medicine, Baltimore, told Medscape Medical News that the efficacy data were 'amazing,' and that the combination 'delivered unprecedented efficacy as judged by biomarkers, specifically the combination of loss of fat mass plus the increase in lean mass. These changes were accompanied by clinically meaningful improvements in blood pressure and glycemic indices. It will be critical to understand the impact on 'hard' clinical endpoints such as cardiovascular outcomes.' However, Taylor added that the trial raised some safety concerns, particularly an increase in LDL cholesterol that the investigators said was transient, but they didn't present data about what measures might have been used by the individual clinicians in the study to mitigate that rise. 'It will be important for the investigators to clarify how statin doses were managed. If the adverse effects of bimagrumab were transient, that could be a favorable scenario. If the LDL cholesterol returned toward baseline because statin doses were increased, that would have different implications,' he said. Obesity expert Amy E. Rothberg, MD, clinical professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, agreed, and also cited other missing information, such as muscle quality. 'There were no biopsies done. They were doing DEXA. That tells us about distribution and volume, but it doesn't tell us anything about quality.' Rothberg also noted that the only objective functional measure was hand grip, while the rest were self-administered survey instruments. 'There are a lot of unknowns, but impressive data just the same.' Hard to Predict Safety Concerns Common adverse events with bimagrumab-containing groups included muscle spasms (ranging from 46.4% with 10 mg to 63.6% with the high-dose combination), diarrhea, and acne, while semaglutide was associated with the typical nausea, diarrhea, constipation, and fatigue. Similar events occurred in the four combination groups, in which 9% of those treated discontinued due to adverse events over 72 weeks. There were no deaths. The bimagrumab-containing groups showed early and transient increases in alanine aminotransferase and lipase, while semaglutide-containing groups had sustained increases in lipase. 'The biology of activin receptors is extremely complex. It is hard to predict all of the possible safety concerns. Phase 3 studies and pharmacovigilance will provide better understanding,' Taylor told Medscape Medical News . 'Some potential safety issues only become apparent when large numbers of people have taken the drug for long periods of time, he said, adding that 'obesity drugs are understandably required to have a very 'clean' safety profile.' The BELIEVE phase 2 study was essentially proof-of-concept, said Heymsfield. Semaglutide is a product of Lilly competitor Novo Nordisk. This unusual situation came about because the study was initiated in 2023 by Versanis Bio, which Lilly later acquired. Lilly is now conducting phase 2 trials of bimagrumab with its own GLP-1-based drug tirzepatide, this time co-formulated with bimagrumab in a subcutaneous injection. Heymsfield has a contract with Lilly for clinical trials (institutional support). He has received honoraria for serving on medical advisory boards of Tanita Corporation, Novo Nordisk, Lilly, Regeneron, Abbott, and Medifast. He is on the Data Safety Monitoring Committee for Novo Nordisk. Aronne receives consulting fees from/and serving on advisory boards for Altimmune, Atria, Eli Lilly, Jamieson Wellness, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Juvena Therapeutics, Kallyope, Novartis, Novo Nordisk, Pfizer, Prosciento, Senda Biosciences, Versanis, Veru Pharmaceuticals, and Zealand Pharmaceuticals; receives research funding from AstraZeneca, United Kingdom, Eli Lilly, Janssen Pharmaceuticals, Belgium, and Novo Nordisk, Denmark; having equity interests in ERX Pharmaceuticals, Intellihealth, Jamieson Wellness, Kallyope, Myos Corp, and Veru Pharmaceuticals; and serves on a board of directors for ERX Pharmaceuticals, Intellihealth, and Jamieson Wellness. Taylor has reported receiving payments from the National Institute of Diabetes and Digestive and Kidney Diseases for an inventor's share of a patent covering metreleptin as a treatment for generalized lipodystrophy. He was employed by Eli Lilly in 2000-2002 and Bristol Myers Squibb in 2002-2013.
Yahoo
24-06-2025
- Business
- Yahoo
Eli Lilly (LLY) Retains $1,100 Price Target at Bernstein Ahead of Diabetes Conference
Eli Lilly & Company (NYSE:LLY) is one of billionaire Stan Druckenmiller's top stock picks with huge upside potential. Bernstein SocGen Group reaffirmed its Outperform rating and $1,100 price target for Eli Lilly & Company (NYSE:LLY) on June 13 ahead of the 85th Annual Meeting of the American Diabetes Association. Pixabay/Public Domain The firm outlined a number of crucial data presentations that Eli Lilly & Company (NYSE:LLY) is expected to provide at the next meeting. One of these is the full description of the ACHIEVE-1 study, which is the first phase 3 trial from the late-stage clinical program of orforglipron. Bernstein is especially keen to acquire more information on the negative event profile and discontinuation rates, even if topline data is already available. Additionally, Eli Lilly & Company (NYSE:LLY) will provide information about its muscle-wasting medication, bimagrumab. When paired with tirzepatide, this will be the first clinical data reported for an anti-muscle wasting agent used in conjunction with a GLP-1 receptor agonist, possibly hinting at future use cases. Eli Lilly & Company (NYSE:LLY) is a major global pharmaceutical company that develops, manufactures, and distributes a wide range of drugs. Founded in 1876, it has grown to become one of the world's largest pharmaceutical companies. While we acknowledge the potential of LLY as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. Read More: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-06-2025
- Health
- Yahoo
Muscle-preserving drugs could generate over $30 billion in sales by 2035, TD Cowen says
By Bhanvi Satija (Reuters) -Treatments designed to help patients preserve muscle while losing weight with popular obesity drugs by Eli Lilly and Novo Nordisk could generate more than $30 billion in sales by 2035, analysts at TD Cowen said on Friday. About a dozen companies are racing to develop such therapies, most of which are being tested in combination with Lilly's Zepbound or Novo's Wegovy, both of which target the GLP-1 protein to help control appetite. The initial Wall Street estimates for muscle-preserving therapies follow promising mid-stage results from experimental drugs developed by Regeneron and Scholar Rock. Investors are closely watching mid-stage data from Lilly's muscle mass-preserving drug, bimagrumab, which is scheduled for presentation at a medical conference next week. Analysts have projected that obesity drugs sales could reach $150 billion a year by the early 2030s. The unmet need to preserve muscle will grow with the use of GLP-1 drugs for obesity, said TD Cowen analyst Tyler Van Buren. Doctors have raised concerns that patients may experience a decrease in overall strength due to muscle loss associated with Zepbound and Wegovy, while experts suggest that more muscle can help patients maintain long-term weight loss. Van Buren said that the first such treatment could launch by 2028, although regulatory challenges remain because these treatments must demonstrate additional health benefits to secure approval. "We believe quality of weight loss and lean mass preservation ... is far too important for long-term health outcomes to be ignored and that this will be figured out," Van Buren said. Some of the new drugs target the myostatin protein, which is associated with muscle growth, and are expected to see broader use due to their superior safety profile, capturing the majority of the market share, Van Buren said. Other drugs target activin, a protein with multiple biological functions. Van Buren said that activin-based drugs will be reserved for patients at higher risk of losing strength, forecasting sales of about $5 billion by 2035.
