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 Jan 2025

Sponsor / Collaborator

The Schwartz Center for Compassionate Healthcare

NCT06643728 / RecruitingPhase 2

A Phase 2, 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 Without Type 2 Diabetes

The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 54 weeks.

Start Date21 Oct 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT05616013 / Active, not recruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women

A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women

Start Date16 Nov 2022

Sponsor / Collaborator

Eli Lilly & Co.

[+1]

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 2024·METABOLISM-CLINICAL AND EXPERIMENTAL

The impact of weight loss on fat-free mass, muscle, bone and hematopoiesis health: Implications for emerging pharmacotherapies aiming at fat reduction and lean mass preservation

Review

Author: Kokkorakis, Michail ; Mantzoros, Christos S. ; Mantzoros, Christos S ; Stefanakis, Konstantinos

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. Loss of muscle and bone as well as anemia can compromise physical function, metabolic rate, and overall health, especially in older adults. The myostatin-activin-follistatin-inhibin system, originally implicated in reproductive function and subsequently muscle regulation, appears to be crucial for muscle and bone maintenance during weight loss. Activins and myostatin promote muscle degradation, while follistatins inhibit their activity in states of negative energy balance, thereby preserving lean mass. 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. Either alone or combined with incretin receptor agonists, these medications may enhance fat loss while preserving or even increasing muscle and bone mass, offering a potential solution for improving body composition and metabolic health during significant weight loss. Since this dual therapeutic approach could help address the challenges of muscle and bone loss during weight loss, well-designed studies are needed to optimize these strategies and assess long-term benefits. 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.

01 Feb 2024·Molecular metabolism

Antibody blockade of activin type II receptors preserves skeletal muscle mass and enhances fat loss during GLP-1 receptor agonism

Article

Author: Baur, Joseph A ; Holman, Corey D ; Seale, Patrick ; Titchenell, Paul M ; Calhoun, Ryan ; Gavin, Matthew ; Nunn, Elizabeth ; Lee, Michelle ; Drareni, Karima ; Uehara, Kahealani ; Jaiswal, Natasha ; Stefkovich, Megan

OBJECTIVE:

Glucagon-like peptide 1 (GLP-1) receptor agonists reduce food intake, producing remarkable weight loss in overweight and obese individuals. While much of this weight loss is fat mass, there is also a loss of lean mass, similar to other approaches that induce calorie deficit. Targeting signaling pathways that regulate skeletal muscle hypertrophy is a promising avenue to preserve lean mass and modulate body composition. Myostatin and Activin A are TGFβ-like ligands that signal via the activin type II receptors (ActRII) to antagonize muscle growth. Pre-clinical and clinical studies demonstrate that ActRII blockade induces skeletal muscle hypertrophy and reduces fat mass. In this manuscript, we test the hypothesis that combined ActRII blockade and GLP-1 receptor agonism will preserve muscle mass, leading to improvements in skeletomuscular and metabolic function and enhanced fat loss.

METHODS:

In this study, we explore the therapeutic potential of bimagrumab, a monoclonal antibody against ActRII, to modify body composition alone and during weight loss induced by GLP-1 receptor agonist semaglutide in diet-induced obese mice. Mechanistically, we define the specific role of the anabolic kinase Akt in mediating the hypertrophic muscle effects of ActRII inhibition in vivo.

RESULTS:

Treatment of obese mice with bimagrumab induced a ∼10 % increase in lean mass while simultaneously decreasing fat mass. Daily treatment of obese mice with semaglutide potently decreased body weight; this included a significant decrease in both muscle and fat mass. Combination treatment with bimagrumab and semaglutide led to superior fat mass loss while simultaneously preserving lean mass despite reduced food intake. Treatment with both drugs was associated with improved metabolic outcomes, and increased lean mass was associated with improved exercise performance. Deletion of both Akt isoforms in skeletal muscle modestly reduced, but did not prevent, muscle hypertrophy driven by ActRII inhibition.

CONCLUSIONS:

Collectively, these data demonstrate that blockade of ActRII signaling improves body composition and metabolic parameters during calorie deficit driven by GLP-1 receptor agonism and demonstrate the existence of Akt-independent pathways supporting muscle hypertrophy in the absence of ActRII signaling.

01 Mar 2023·Peptides

An update on peptide-based therapies for type 2 diabetes and obesity

Review

Author: Flatt, Peter R ; Conlon, J Michael ; Bailey, Clifford J

Long-acting analogues of the naturally occurring incretin, glucagon-like peptide-1 (GLP-1) and those modified to interact also with receptors for glucose-dependent insulinotropic polypeptide (GIP) have shown high glucose-lowering and weight-lowering efficacy when administered by once-weekly subcutaneous injection. These analogues herald an exciting new era in peptide-based therapy for type 2 diabetes (T2D) and obesity. Of note is the GLP-1R agonist semaglutide, available in oral and injectable formulations and in clinical trials combined with the long-acting amylin analogue, cagrilintide. Particularly high efficacy in both glucose- and weight lowering capacities has also been observed with the GLP-1R/GIP-R unimolecular dual agonist, tirzepatide. In addition, a number of long-acting unimolecular GLP-1R/GCGR dual agonist peptides and GLP-1R/GCGR/GIPR triagonist peptides have entered clinical trials. Other pharmacological approaches to chronic weight management include the human monoclonal antibody, bimagrumab which blocks activin type II receptors and is associated with growth of skeletal muscle, an antibody blocking activation of GIPR to which are conjugated GLP-1R peptide agonists (AMG-133), and the melanocortin-4 receptor agonist, setmelanotide for use in certain inherited obesity conditions. The high global demand for the GLP-1R agonists liraglutide and semaglutide as anti-obesity agents has led to shortage so that their use in T2D therapy is currently being prioritized.

News (Medical) associated with Bimagrumab

06 Nov 2024

·endpts.com

‘We’re good’ on weight loss: Biopharmas turn to muscle with new obesity drugs

SAN ANTONIO — It took decades to get to the GLP-1 breakthrough in obesity treatment. Now, the biopharma industry is clamoring over the field’s next frontier: staving off the losses in muscle or lean mass that have been seen with existing drugs. Muscle preservation has become an increasing focus as leaders gathered in Texas this week for ObesityWeek, one of the main medical research conferences centered around the chronic disease. “If you look at the field of incretins — whether it’s single agonists, dual agonists, triple agonists — in my mind, I don’t think we need more weight loss,” Scholar Rock CSO Mo Qatanani told Endpoints News on the sidelines of the confab. “As far as weight loss, I think we’re good; there’s a lot of advancement there,” he added. “I think the next step to look at is this healthier weight loss that you can maintain, that’s durable.” Muscle preservation is key for a variety of health reasons, including implications on metabolism and the overall endocrine system, said Volkan Granit, a Biohaven medical director and neurologist. Retaining muscle mass is particularly relevant for elderly patients, he said, noting the risk of sarcopenia. Biohaven and Scholar Rock are developing myostatin-focused drugs for both spinal muscular atrophy and obesity. If muscle is retained, it could also help extend the durability of obesity drugs and lead to more fat loss, leaders in the field said. Patients on GLP-1s are losing more muscle in a year than they normally would in 10 years, Veru CEO Mitchell Steiner said. The Miami-based biotech is testing an oral selective androgen receptor modulator called enobosarm in a Phase 2b trial in combination with Wegovy. The company will have 16-week data in January 2025, and it plans to run two Phase 3 studies in obesity, for which a partner “would be wonderful,” Steiner said. The GLP-1s aren’t alone in affecting muscle loss. Many types of weight loss approaches, like gastric bypass surgery and caloric restriction, also impair lean mass, according to leaders in the field. “The rule of thumb is you want to keep it 70/30: 70% loss of fat, 30% loss of lean body mass,” said Nikhil Dhurandhar, chair of the nutritional sciences department at Texas Tech University and editor-in-chief of the International Journal of Obesity . Studies have shown about 25% to 55% of lean body mass loss for the GLP-1 class, Dhurandhar said, describing it as a “big deal.” At this point, though, he said he’s a proponent of adding walking exercises and “adequate protein diet” interventions on top of GLP-1 treatment rather than additional obesity medicines. Eli Lilly and Novo Nordisk, the GLP-1 behemoths, are among those also developing medicines thought to have less of an impact on muscle loss. “We’re all waiting for the big gorilla in the room to materialize, which is the ongoing, now Lilly-sponsored trial with bimagrumab plus semaglutide,” SixPeaks Bio CEO Philip Just Larsen said. AstraZeneca has the option to buy his preclinical biotech, which is developing activin-focused drugs for what it calls “healthy weight loss.” Bimagrumab aims to block both activin and myostatin signaling. The drug was originally at Novartis, then swooped up by Versanis Bio, which Lilly bought for up to $1.9 billion last year. Versanis was testing bimagrumab in combination with semaglutide, but Lilly has yet to report those results. Last month, the Indianapolis-based pharma started a new trial testing the injectable in combination with tirzepatide. Nadia Ahmad, an associate VP who leads Lilly’s Phase 3 obesity trials, said it has to be thought of in a broader body composition lens. “With potential investigational medications like bimagrumab, it’s about the fat mass as much as it is about muscle preservation,” Ahmad said on the sidelines of ObesityWeek, “and being able to really hone in on efficacy from a fat mass reduction standpoint, because that’s the crux of what we’re trying to treat here.” Drug developers are also looking at the pancreatic hormone amylin as a potential way of honing in on selective fat loss. Zealand Pharma thinks its petrelintide asset, weeks away from entering Phase 2, could be a “ foundational ,” first-line approach that could rid the need for GLP-1 for some patients. Novo also has an amylin program, combined with semaglutide, that will have key Phase 3 data by year’s end. AstraZeneca also highlighted the potential for amylin earlier this week, as did Structure Therapeutics.

Phase 2Phase 3

25 Sep 2024

·www.biospace.com

Lilly and Novo Spend Billions to Expand Obesity Pipelines Beyond GLP-1s

Novo and Lilly/Taylor Tieden for BioSpace Novo Nordisk and Eli Lilly are expected to rule the obesity market for a few more years without much challenge. To ensure they stay there as competition enters, the companies are spending billions in licensing and M&A deals. Novo Nordisk and Eli Lilly are undoubtedly at the top of the weight loss market. With $1.7 billion in second-quarter sales recorded for Novo’s Wegovy and $1.2 billion for Lilly’s Zepbound, the companies are raking in profits. The two behemoths are likely to remain in that spot until competitors begin to arrive on the market around 2026, according to a report from Pitchbook and Morning Star issued on September 9. But the next wave of drugs, coming from companies like Terns Pharmaceuticals, Structure Therapeutics, Pfizer and Amgen, look like they could beat the current offerings. All these companies could come together to battle for a market Pitchbook estimates could reach $200 billion annually by 2031. But Lilly and Novo are not standing idly by. They’ve been scooping up companies and making deals, diversifying their bets on obesity treatments. And both pharmas are highly anticipated to make further acquisitions in the space, according to the report. Both have also taken smaller bites with licensing deals to explore new targets or next-generation GLP-1 approaches. Obesity is a key investment focus for Novo, executives said during an investor day presentation in March. Of the two, Novo has been the most prolific on the business development stage by far, with 37 partnerships focused on cardiometabolic diseases and obesity, according to the presentations. The company is specifically focused on finding new mechanisms of action. For example, Novo is heavily investing in siRNA technology for a number of therapy areas, the majority of which are in diabetes and obesity. The company is also building out internal capabilities in proteins, peptides and monoclonal antibodies, while partnerships and acquisitions are adding small molecule options to its obesity pipeline. Meanwhile, Lilly allocated $1.4 billion for business development overall, including milestones, closed acquisitions and equity investments in the first half of the year. Another $4.4 billion went to total R&D; the pharma has 11 new molecules in development for obesity, including a robust late-stage program and nine trials currently running. “In obesity, our strategy is to comprehensively address this global public health crisis, pursuing opportunities against every rational mechanism, indication, and dosage form,” said CEO David Ricks on the company’s second quarter earnings call in early August. Read on for more on the deals that Novo and Lilly hope will keep them at the top of the obesity world. Lilly: Haya Therapeutics Partnership Date: September Value: Up to $1 billion Asset(s): Multiple RNA targets Most recently, Lilly put up to $1 billion on the line —although the exact financial breakdown was not disclosed—to work with Haya Therapeutics earlier this month. The Swiss biotech is using an RNA-guided genome platform to target obesity and other metabolic conditions. Haya will conduct drug discovery to find multiple tissue-, disease- and cell-specific long non-coding RNA targets (lncRNA) to develop into therapeutics. Specifically, Lilly is looking for treatments with better efficacy and less toxicity than existing options for weight loss. That’s, of course, the holy grail. While Wegovy and Zepbound are undeniably effective, they are associated with gastrointestinal side effects and muscle loss. The next generation of therapies will seek to imnprove on those two measures, but also on delivery. Novo: Metaphore Partnership Date: May Value: $600 million Asset(s): Two GLP-1 receptor agonists Novo has worked with venture creation firm Flagship Pioneering since 2022 (see below), but in May, they doubled down. The Danish pharma signed a deal with one of Flagship’s portfolio companies, Metaphore Biotechnologies, to develop two next-generation GLP-1 receptor agonists. The deal included up to $600 million in upfront, development and milestone payments. Novo plans to use Metaphore’s MIMIC platform, which can copy the interactions between molecules to develop therapeutics to activate the GLP-1 receptor and related pathways. The deal also includes “a novel machine learning approach to obesity management,” the companies said in announcing the deal. Novo: Catalent Acquisition Date: February Value: $16.5 billion Asset(s): Three fill finish sites This list would not be complete without this outlier, Novo Holdings’ $16.5 billion acquisition of contract development and manufacturing organization Catalent. This deal does not bolster Novo’s pipeline, exactly, but will certainly support the company’s obesity-driven revenue. Novo Nordisk’s holding company took control of three of Catalent’s manufacturing sites to bolster production of the blockbuster drugs Ozempic for diabetes and Wegovy for weight loss. Both use the same active ingredient, semaglutide. The troubled manufacturer had revenue losses of $539 million in 2023 as demand for COVID-19 vaccines and treatments waned, plus debt of more than $5 billion. The company had also faced multiple quality control concerns. Novo: EraCal Licensing Deal Date: January Value: $255 million Asset(s): Oral small molecule program Sometimes, you have to dig a little deeper into existing partnerships. Novo did exactly that, adding on a new mechanism of action in obesity through a $255 million licensing deal with Swiss biotech EraCal Therapeutics signed in January. The deal granted Novo exclusive rights to EraCal’s oral small molecule program, which aims to control appetite and body weight to treat obesity. The two companies had been working together since 2022, when they entered into a collaboration to find targets for food intake regulation and other metabolic phenotypes. The partnership examined zebrafish larvae to find new targets to act against obesity. Novo: Omega Therapeutics Licensing Deal Date: January Value: $532 million Asset(s): Epigenomic controller program Novo inked the first of two licensing options in obesity this year with Flagship in January, starting with Omega Therapeutics . The pharma opted in on a program designing an epigenomic controller designed to enhance metabolic activity, with the hope of developing a new treatment for obesity management. The agreement also included a second opt-in for a metabolic dysfunction-associated steatohepatitis (MASH) therapy with Flagship’s Cellarity. Flagship’s Pioneering Medicines and Novo will jointly support the programs through preclinical work and then Novo will advance them into the clinic and reimburse R&D costs. Novo pledged $532 million upfront for each agreement in upfront, development and commercial milestone payments. Lilly: Fauna Partnership Date: December 2023 Value: $494 million Asset(s): Multiple weight loss targets Lilly looked to the animal kingdom for some new weight loss targets in a deal signed with Fauna Bio worth up to $494 million in December 2023. The multi-year partnership will see the two work on finding new targets for weight loss drugs using Fauna’s artificial intelligence platform called Convergence. The platform analyzes genomic data from 452 animal species and tissues along with human data to find novel drug targets. Lilly: BioAge Trial Partnership Date: October 2023 Value: Not disclosed Asset(s): Azelaprag Lilly’s partnership with BioAge stands out a bit on this list. The companies agreed to work together on a clinical trial pairing the biotech’s apelin receptor APJ agonist azelaprag with Lilly’s Zepbound. The hope with thethis clinical trial is that the combo will boost the weight loss potential of Lilly’s mega-blockbuster. These kinds of clinical trial supply agreements happen all the time, but Lilly is conducting the research through its independent clinical development organization called Chorus. The unit works with biotechs to develop assets through clinical proof of concept. Lilly put more skin in the game by also participating in BioAge’s series D financing in February. BioAge raised $170 million with backing from RA Capital, Cormorant, SV Health, Lilly and Amgen. The biotech has since filed to go public and is seeking up to $153.3 million, according to a September 18 SEC filing . Novo: Embark Biotech Acquisition Date: August 2023 Value: $507 million Asset(s): Embark Biotech, assets from Embark Laboratories Novo did a double deal with Embark Laboratories in August 2023, fully acquiring Embark Biotech and signing a three-year research collaboration with the lab. In Embark Biotech, Novo scored a metabolic program for up to $507 million. And for the research collaboration, Novo gained an option to acquire selected assets retained by Embark Laboratories based on Embark Biotech discoveries in obesity, type 2 diabetes and other indications. Novo: Inversago Pharma Acquisition Date: August 2023 Value: $1.1 billion Asset(s): Inversago Pharma Novo is already seeing the fruits of its $1.1 billion buyout of Inversago Pharma , a Canadian company that had been developing novel cannabinoid receptor 1 (CB1) receptor-based therapies. The August 2023 deal brought in a new modality for Novo to explore in its ever-expanding obesity pipeline. Just last week, the company revealed the first results for one of the candidates, monlunabant, showing that the oral CB1 inverse agonist cut weight by 15 lbs after 16 weeks. The data reveal was low on detail, however, and Novo did not present the weight loss as a percentage of bodyweight, which has been common in these types of trials. Novo also noted some “mild to moderate neuropsychiatric side effects,” such as anxiety, irritability and sleep disturbances. This class of drugs has been known to cause neuropsychiatric issues, including suicidality, so Novo said it intends to work with the dosing in future trials, after proving that monlunabant can in fact reduce weight. Lilly: Versanis Bio Acquisition Date: July 2023 Value: $1.925 billion Asset(s): Versanis Bio In July 2023 , Lilly swept in and bought out Versanis , a biotech that had formed around a Novartis castoff, for $1.925 billion. At the center of the deal is bimagrumab , a monoclonal antibody that aims to reduce fat without affecting muscle mass. Novartis developed the therapy in muscle disorders but studies failed to show improvement in patients’physical function. Researchers did, however, note that people taking the drug lost weight. Fast-forward to the weight loss craze that is sweeping the pharmaceutical industry, and Lilly jumped on Novartis’ discard through the nearly $2 billion outlay. Bimagrumab is being tested in the Phase IIb BELIEVE study for adults to achieve and maintain fat loss and a healthy body composition. Completion is expected in mid-2025, according to ClinicalTrials.gov . Novo: Flagship Partnership Date: May 2022 Value: Not disclosed Asset(s): Multiple company partnerships Why work with one company when you could work with 41? That’s what Novo did in signing a partnership with prolific biotech creator Flagship Pioneering in May 2022. The deal focused on cardiometabolic and rare diseases, providing Novo with access to the platforms developed by Flagship’s many companies. Novo offered funding for initiated research programs and will have an exclusive option on any programs licensed from the deal. The goal was to kickstart three to five programs within the first three years. The deal has since produced collaborations with Metaphore and Omega in obesity (see above), plus Cellarity in MASH. Novo: Dicerna Acquisition Date: December 2021 Value: $3.3 billion Asset(s): Dicerna Novo tapped into Dicerna Pharmaceuticals in 2019 to find new RNAi therapies, in a partnership that examined 30 liver cell targets that could yield new therapeutics in MASH, type 2 diabetes, obesity and rare diseases.  Satisfied with the work, Novo went all in, buying out the company entirely in November 2021 for about $3.3 billion. The first target from the original collaboration, a NASH drug, entered the clinic in 2022, but Novo was also looking to the deal to expand the company’s RNAi research. Besides obesity, Novo sees the possibility for Dicerna’s technology to find therapies for diabetes, cardiovascular disease, MASH and endocrine and bleeding disorders. Novo: Kallyope Licensing Deal Date: June 2018, September 2024 Value: Not disclosed Asset(s): Ligand for obesity This deal has a slow burn. Originally signed in June 2018 , Novo and Kallyope agreed to discover novel peptides for obesity and diabetes. No financial details were released at the time, but the deal involved an upfront fee and research support. Novo gained the rights to up to six products and offered a licensing fee if any were optioned. Kallyope is exploring the gut-brain axis, with four programs underway for metabolism. Earlier this month, we finally heard how the partnership was going . Novo exercised an option to license a ligand identified by Kallyope for obesity. Again, financial details were kept under wraps. Novo said it believes it’s found a new mechanism for obesity in the Kallyope program. Now, the Danish pharma will take over preclinical and clinical development, manufacturing and commercialization. Kallyope has received an upfront option payment and may receive additional payments down the line in development and sales milestones and royalties.

AcquisitionLicense out/inPhase 2

05 Sep 2024

·www.pharmaceutical-technology.com

Lilly partners with Haya for lncRNA obesity target deal worth $1bn

Eli Lilly and Haya Therapeutics aim to find multiple regulatory genome derived RNA-based drug targets for obesity. Credit: eamesBot via Shutterstock. Pharma giant Eli Lilly is teaming up with Haya Therapeutics in a $1bn deal to find multiple regulatory-genome-derived RNA-based drug targets, as it eyes up new targets in obesity. Under the deal, the companies will use Haya’s proprietary regulatory genome discovery platform to identify and validate long non-coding RNA (lncRNA) targets for developing potential treatments for obesity and related metabolic disorders. Until now, Haya has focused its drug discovery platform on fibrotic diseases, cardiovascular and metabolic diseases, and cancer. However, preclinical studies – including one published in the journal Non-coding RNA Research – have demonstrated that lncRNAs also play a role in the development of adipose cells and obesity. Switzerland-based Haya’s platform focuses on tissue, disease, and cell-specific lncRNA and RNA molecules more than 200 nucleotides long, which regulate gene expression without coding for proteins. The company’s lead development candidate, HTX-001, is an antisense oligonucleotide targeting the lncRNA Wisper, which is associated with myocardial fibrosis and heart failure. See Also: Solute Carrier Family 2 Facilitated Glucose Transporter Member 1 drugs in development, 2024 Solute Carrier Family 12 Member 2 drugs in development, 2024 It comes as no surprise that Lilly is eyeing up new targets in obesity, as it is one of the frontrunners in the space. Its blockbuster drug tirzepatide, which is marketed as Mounjaro for type 2 diabetes and Zepbound for obesity is the main competitor for Novo Nordisk ’s semaglutide versions, Ozempic and Wegovy. Lilly reported $5.34bn in sales for both Mounjaro and Zepbound last year, as per the company financials. This is among a series of deals Lilly has made to identify new obesity drug candidates, including a $1.92bn agreement to acquire Boston-based Versanis and its lead asset bimagrumab in July 2023. Bimagrumab, a monoclonal antibody that attaches to activin type II A and B receptors, is currently being evaluated in the Phase IIb BELIEVE clinical trial both as a monotherapy and along with semaglutide in adults who are obese or overweight. Lilly also isn’t the first big pharma company to jump into the lncRNA space. This deal comes one week after Bayer teamed up with lncRNA-focused NextRNA in a $547m deal. The companies will collaborate on two oncology programmes, the first involving a lncRNA-targeting small molecule in early preclinical development at NextRNA, and a new target identified by NextRNA’s platform, with Bayer having the option to choose one target for joint development. In the announcement accompanying the deal, Haya’s CEO Samir Ounzain said: “This partnership with Lilly demonstrates the significant advances we have made with our revolutionary regulatory genome RNA-guided platform and validates the potential of targeting lncRNA for chronic conditions.” mRNA vaccine coverage on Pharmaceutical Technology (Or Clinical Trials Arena) is supported by Trilink . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper mRNA capping: low cost, high reward Are you aware of the latest mRNA capping techniques? The success of mRNA-based Covid vaccines has seen the technology boom in popularity – but capping is an essential part of the manufacturing process, and pharmaceutical firms face a range of choices on how to do it. This free whitepaper assesses differences in price, time, complexity and availability for the methods on offer – and provides essential insights on TriLink’s trailblazing CleanCap® approach. Fill in your details to find out more. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Trilink Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Trilink Thematic and that your personal data will be used as described in their Privacy Policy

VaccinePhase 2AcquisitionOligonucleotidemRNA

100 Deals associated with Bimagrumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10620	Bimagrumab	-	DB12584

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myositis, Inclusion Body	Phase 3	US	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	JP	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	AU	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	BE	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	DK	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	FR	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	IT	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	NL	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	CH	Novartis Pharmaceuticals Corp.	02 Nov 2015
Myositis, Inclusion Body	Phase 3	GB	Novartis Pharmaceuticals Corp.	02 Nov 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SO 52 (EASD2023)	Phase 1/2	Weight Loss \| Muscular Atrophy	-	Bimagrumab 3 mg/kg	ztrmtyvpkm(dhstwpmwjc) = khpmoflnvf cqkwiwobih (rscnrmvquo )	Positive	04 Oct 2023
				Bimagrumab 10 mg/kg	xfqkijawpw(irofmbjzid) = hayzuvfexb pregdbzfwe (gjetobjxso )
NCT05616013 (ADA2023)	Phase 2	Weight Loss	75	Bimagrumab 10 mg/kg IV	pyfwnjfkee(htzzjupucw) = spbflkyvtk enyyiejmzg (qxsjwfyrxv ) View more	-	20 Jun 2023
				Placebo	pyfwnjfkee(htzzjupucw) = onhpeqzdkg enyyiejmzg (qxsjwfyrxv ) View more
PRNewswire Manual	Phase 2	Diabetes Mellitus	569	Bimagrumab	znzmbemxyk(czkwmdbhgf) = tegzzgjlrf kqebvcgfwr (ukwsijbtgb )	Positive	11 Jun 2022
				Placebo	znzmbemxyk(czkwmdbhgf) = xakrygoqun kqebvcgfwr (ukwsijbtgb )
NCT03005288 (Pubmed \| JAMA Netw Open) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	75	Bimagrumab	bkzjyetrnf(ywqrmncnnx) = glwinbknvn pibdzbnygi (gqqrmpxrjp, -8.3 to -6.6) View more	Positive	04 Jan 2021
				Placebo	bkzjyetrnf(ywqrmncnnx) = ljfkbfalhm pibdzbnygi (gqqrmpxrjp, -0.99 to 0.63) View more
NCT02250443 (Pubmed \| Ann Neurol) Manual	Phase 2/3	Myositis, Inclusion Body	10	Bimagrumab	ulaljshure(rfmajheciv) = muscle spasms and falls (both 9 of 10, 90%),diarrhea (6 of 10, 60%) and acne and skin eruption (both 5 of 10, 50%) ztoeifvwgu (pvsicixzcs )	Negative	06 Oct 2020
NCT02333331 (Pubmed \| JAMA Netw Open) Manual	Phase 2	Sarcopenia	180	SOC+Bimagrumab	jjdlufmirw(fckfvjicxd) = bzmneztxgx gikykvpqus (ctvoulwind, 0.90 - 1.77) View more	Positive	01 Oct 2020
				SOC+Placebo	jjdlufmirw(fckfvjicxd) = zjlnwsrktd gikykvpqus (ctvoulwind, 0.53 - 1.52) View more
NCT03005288 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	78	BYM338 10 mg/kg (BYM338 10 mg/kg)	pntkrbsagr(vonyevoewg) = ixlnnydjtb sntpfujhed (ltpylaolmf, rtfoafadpy - upfdxnidhy) View more	-	04 Jun 2020
				Placebo (Placebo)	pntkrbsagr(vonyevoewg) = lduizbiqvo sntpfujhed (ltpylaolmf, lfikwhngdi - uakysfzgka) View more
NCT01925209 (RESILIENT, Pubmed) Manual	Phase 2	Myositis, Inclusion Body	251	bimagrumab	jrtvywnzwn(vgdnfrieev) = hzaqlzkjuf lzsyoxlouc (afvivkrswe )	Negative	01 Sep 2019
				Placebo	kwkxlsbsuh(tdpdbleyje) = lgziwwopzh jfgmdfqkhe (juyqlxfjbz ) View more
NCT02333331 (CTgov)	Phase 2	Sarcopenia	217	bimagrumab (BYM338 70 mg)	jhgiwjgrlt(wfammmdyer) = bhlyskfbkt timgfjsieb (nhwzjstjtk, rnqxynirqj - qegtkrigel) View more	-	06 Aug 2019
				bimagrumab (BYM338 210 mg)	jhgiwjgrlt(wfammmdyer) = ysngtdhqzf timgfjsieb (nhwzjstjtk, ufmubicyxk - ypahivtxug) View more
NCT02250443 (BYM338, CTgov)	Phase 2/3	Myositis, Inclusion Body	10	BYM338 (Bimagrumab)	afmycbhjrc(dztkzvhlmi) = kvnqfllfhq zvacfczaqa (uexwyjqrty, tfxtnshbxt - ihprulzbma) View more	-	10 Apr 2018

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