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REVIEW
Eka Melson, Uzma Ashraf, Dimitris Papamargaritis, Melanie J Davies
Obesity is a chronic disease associated with increased risk of obesity-related complications and mortality. Our better understanding of the weight regulation mechanisms and the role of gut-brain axis on appetite has led to the development of safe and effective entero-pancreatic hormone-based treatments for obesity such as glucagon-like peptide-1 (GLP-1) receptor agonists (RA). 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...
February 1, 2024: International Journal of Obesity
#2
JOURNAL ARTICLE
Elizabeth Nunn, Natasha Jaiswal, Matthew Gavin, Kahealani Uehara, Megan Stefkovich, Karima Drareni, Ryan Calhoun, Michelle Lee, Corey D Holman, Joseph A Baur, Patrick Seale, Paul M Titchenell
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...
February 2024: Molecular Metabolism
#3
REVIEW
Clifford J Bailey, Peter R Flatt, J Michael Conlon
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...
March 2023: Peptides
#4
RANDOMIZED CONTROLLED TRIAL
Olivier Petricoul, Arman Nazarian, Uwe Schuehly, Ursula Schramm, Olivier J David, Didier Laurent, Jens Praestgaard, Ronenn Roubenoff, Dimitris A Papanicolaou, Daniel Rooks
BACKGROUND: Bimagrumab is a human monoclonal antibody binding to the activin type II receptor with therapeutic potential in conditions of muscle wasting and obesity. This phase I study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of various dose regimens of bimagrumab and routes of administration in healthy older adults. METHODS: This was a randomized, double-blind, placebo-controlled, parallel-arm, multiple-dose study in older adult men and women (aged ≥ 70 years, body mass index [BMI] 18-34 kg/m2 ) with stable health and diet...
January 2023: Clinical Pharmacokinetics
#5
REVIEW
Rachel Zeng, Stefanie Glaubitz, Jens Schmidt
Inflammatory myopathies, including polymyositis (PM), dermatomyositis (DM), inclusion body myositis (IBM), necrotizing myopathy (NM), antisynthetase syndrome (ASS) and overlap myositis (OM), in short myositis, are rare diseases. All forms of myositis have progressive muscle weakness in common, with each subtype characterized by different autoantibody profiles, histological findings and extramuscular manifestations. Due to better understanding of the pathogenesis of the muscle inflammation in myositis, new molecular pathways for targeted therapy have been discovered...
April 2022: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
#6
JOURNAL ARTICLE
Donna H Ryan
Older medications approved for chronic weight management (orlistat, naltrexone/bupropion, liraglutide 3 mg and, in the USA, phentermine/topiramate) have not been widely adopted by health care providers. Those medications produce only modest additional weight loss when used to augment lifestyle intervention. However, semaglutide 2.4 mg weekly has recently emerged and produces much more weight loss - on average 15% weight loss at 1 year. Semaglutide's enhanced efficacy and that its class (GLP-1 receptor analogs) is well-known may result in more clinicians adopting pharmacotherapy...
2022: Handbook of Experimental Pharmacology
#7
REVIEW
Donna H Ryan
There is a new generation of antiobesity drugs in development or just arriving on the scene. First, setmelanotide has been approved for three of the ultrarare genetic conditions that cause obesity-pro-opiomelanocortin deficiency, proprotein convertase subtilisin and kexin type 1 (an important enzyme in the melanocortin pathway) and leptin receptor deficiency. Setmelanotide marks the first in a personalized medicine approach to obesity. Second, semaglutide 2.4 mg once weekly has been submitted to regulators in the United States and the European Union for approval for patients with obesity (body mass index [BMI] ≥30 kg/m2 ) or overweight (BMI ≥27 kg/m2 ) and at least one weight related comorbidity...
September 30, 2021: Journal of obesity & metabolic syndrome
#8
JOURNAL ARTICLE
Robert W Spitz, Scott J Dankel, Zachary W Bell, Vickie Wong, Takashi Abe, Minsoo Kang, Jeremy P Loenneke
AIM: Diseases and bed rest may result in decreased muscle size and function. While exercise is recommended as a countermeasure, there are times when diseases or injuries make it difficult for the patient to partake in an exercise intervention. Pharmaceutical interventions using a myostatin inhibitor, BYM338, have been investigated as a way to increase or maintain muscle function. Of interest in the present analysis was the 6-min walk test. The 6-min walk test was selected, as there is an association between walking ability and the ease of performing activities of daily living...
October 2021: Geriatrics & Gerontology International
#9
REVIEW
Mohamad Sirri Tarazi, Samir Touhamy, Beverly G Tchang, Alpana P Shukla
INTRODUCTION: Given the relationship between the pathogenesis of obesity and type 2 diabetes mellitus (T2DM) as well as their significant health consequences, treatment strategies that can induce weight loss while achieving glycemic control are needed. Novel weight-reducing anti-diabetic agents along with anti-obesity medications (AOMs) can help medical providers address both conditions simultaneously and effectively. AREAS COVERED: This review summarizes and compares weight loss efficacy and glycemic control of weight-reducing anti-diabetic medications, AOMs and emerging pharmacologic agents that help treat both obesity and T2DM...
November 2021: Expert Opinion on Pharmacotherapy
#10
RANDOMIZED CONTROLLED TRIAL
Anthony A Amato, Michael G Hanna, Pedro M Machado, Umesh A Badrising, Hector Chinoy, Olivier Benveniste, Ananda Krishna Karanam, Min Wu, László B Tankó, Agnes Annette Schubert-Tennigkeit, Dimitris A Papanicolaou, Thomas E Lloyd, Merrilee Needham, Christina Liang, Katrina A Reardon, Marianne de Visser, Dana P Ascherman, Richard J Barohn, Mazen M Dimachkie, James A L Miller, John T Kissel, Björn Oskarsson, Nanette C Joyce, Peter Van den Bergh, Jonathan Baets, Jan L De Bleecker, Chafic Karam, William S David, Massimiliano Mirabella, Sharon P Nations, Hans H Jung, Elena Pegoraro, Lorenzo Maggi, Carmelo Rodolico, Massimiliano Filosto, Aziz I Shaibani, Kumaraswamy Sivakumar, Namita A Goyal, Madoka Mori-Yoshimura, Satoshi Yamashita, Naoki Suzuki, Masashi Aoki, Masahisa Katsuno, Hirokazu Morihata, Kenya Murata, Hiroyuki Nodera, Ichizo Nishino, Carla D Romano, Valerie S L Williams, John Vissing, Lixin Zhang Auberson
OBJECTIVE: To assess long-term (2 years) effects of bimagrumab in participants with sporadic inclusion body myositis (sIBM). METHODS: Participants (aged 36-85 years) who completed the core study (RESILIENT [Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients]) were invited to join an extension study. Individuals continued on the same treatment as in the core study (10 mg/kg, 3 mg/kg, 1 mg/kg bimagrumab or matching placebo administered as IV infusions every 4 weeks)...
March 23, 2021: Neurology
#11
RANDOMIZED CONTROLLED TRIAL
Steven B Heymsfield, Laura A Coleman, Ram Miller, Daniel S Rooks, Didier Laurent, Olivier Petricoul, Jens Praestgaard, Therese Swan, Thomas Wade, Robert G Perry, Bret H Goodpaster, Ronenn Roubenoff
IMPORTANCE: Antibody blockade of activin type II receptor (ActRII) signaling stimulates skeletal muscle growth. Previous clinical studies suggest that ActRII inhibition with the monoclonal antibody bimagrumab also promotes excess adipose tissue loss and improves insulin resistance. OBJECTIVE: To evaluate the efficacy and safety of bimagrumab on body composition and glycemic control in adults with type 2 diabetes and overweight and obesity. DESIGN, SETTING, AND PARTICIPANTS: This double-masked, placebo-controlled, 48-week, phase 2 randomized clinical trial was conducted among adults with type 2 diabetes, body mass index between 28 and 40, and glycated hemoglobin (HbA1c) levels between 6...
January 4, 2021: JAMA Network Open
#12
RANDOMIZED CONTROLLED TRIAL
Daniel Rooks, Olivier Petricoul, Jens Praestgaard, Michael Bartlett, Didier Laurent, Ronenn Roubenoff
BACKGROUND: Bimagrumab prevents activity of myostatin and other negative regulators of skeletal muscle mass. This randomized double-blind, placebo-controlled study investigated safety, pharmacokinetics (PK), and pharmacodynamics of bimagrumab in healthy older and obese adults. METHODS: A cohort of older adults (aged 70-85 years) received single intravenous infusions of bimagrumab 30 mg/kg (n = 6) or 3 mg/kg (n = 6) or placebo (n = 4) and was followed for 20 weeks...
December 2020: Journal of Cachexia, Sarcopenia and Muscle
#13
RANDOMIZED CONTROLLED TRIAL
Daniel Rooks, Therese Swan, Budhaditya Goswami, Lee Anne Filosa, Ola Bunte, Nicolas Panchaud, Laura A Coleman, Ram R Miller, Elisa Garcia Garayoa, Jens Praestgaard, Robert G Perry, Chris Recknor, Charles M Fogarty, Hidenori Arai, Liang-Kung Chen, Jun Hashimoto, Yoon-Sok Chung, John Vissing, Didier Laurent, Olivier Petricoul, Sarah Hemsley, Estelle Lach-Trifilieff, Dimitris A Papanicolaou, Ronenn Roubenoff
IMPORTANCE: The potential benefit of novel skeletal muscle anabolic agents to improve physical function in people with sarcopenia and other muscle wasting diseases is unknown. OBJECTIVE: To confirm the safety and efficacy of bimagrumab plus the new standard of care on skeletal muscle mass, strength, and physical function compared with standard of care alone in community-dwelling older adults with sarcopenia. DESIGN, SETTING, AND PARTICIPANTS: This double-blind, placebo-controlled, randomized clinical trial was conducted at 38 sites in 13 countries among community-dwelling men and women aged 70 years and older meeting gait speed and skeletal muscle criteria for sarcopenia...
October 1, 2020: JAMA Network Open
#14
MULTICENTER STUDY
Kumaraswamy Sivakumar, Thomas I Cochrane, Birgitte Sloth, Hardik Ashar, Didier Laurent, László B Tankó, Anthony A Amato
OBJECTIVE: To assess the long-term safety and tolerability and to monitor benefits of extended use of bimagrumab in individuals with sporadic inclusion body myositis (sIBM) who completed a single-dose core study. METHODS: In this multicenter, open-label extension study, 10 adults received bimagrumab 10 mg/kg IV every 4 weeks up to 2 years (104 weeks). Safety (primary endpoint) was assessed by recording adverse events (AEs). Clinical benefits were assessed by changes from baseline in thigh muscle volume (TMV), lean body mass (LBM), 6-minute walk distance (6MWD), handgrip, and quadriceps strength...
October 6, 2020: Neurology
#15
JOURNAL ARTICLE
Jun Yang, Brian Balog, Kangli Deng, Brett Hanzlicek, Anna Rietsch, Mei Kuang, Shinji Hatakeyama, Estelle Lach-Trifilieff, Hui Zhu, Margot S Damaser
Weakness of urinary sphincter and pelvic floor muscles can cause insufficient urethral closure and lead to stress urinary incontinence. Bimagrumab is a novel myostatin inhibitor that blocks activin type II receptors, inducing skeletal muscle hypertrophy and attenuating muscle weakness. β2 -Adrenergic agonists, such as 5-hydroxybenzothiazolone derivative (5-HOB) and clenbuterol, can enhance muscle growth. We hypothesized that promoting muscle growth would increase leak point pressure (LPP) by facilitating muscle recovery in a dual-injury (DI) stress urinary incontinence model...
September 1, 2020: American Journal of Physiology. Renal Physiology
#16
MULTICENTER STUDY
Madoka Mori-Yoshimura, Satoshi Yamashita, Naoki Suzuki, Masahisa Katsuno, Kenya Murata, Hiroyuki Nodera, Rie Teshima, Tatsumi Inamura, Ichizo Nishino, Masashi Aoki
A global, randomized, double-blind placebo-controlled study was conducted to confirm that BYM338 (bimagrumab), an anti-activin type II receptor antibody, improves motor function in patients with sporadic inclusion body myositis after 52 weeks' treatment consisting of intravenous administration every 4 weeks at doses of 10, 3, and 1 mg/kg. In a Japanese sub-population (20 patients in total, 5 per dose group), no significant differences in the change from baseline of the 6-minute walking distance at Week 52 (primary endpoint) were observed between the placebo group and each BYM338 dose group...
December 25, 2019: Rinshō Shinkeigaku, Clinical Neurology
#17
RANDOMIZED CONTROLLED TRIAL
Michael G Hanna, Umesh A Badrising, Olivier Benveniste, Thomas E Lloyd, Merrilee Needham, Hector Chinoy, Masashi Aoki, Pedro M Machado, Christina Liang, Katrina A Reardon, Marianne de Visser, Dana P Ascherman, Richard J Barohn, Mazen M Dimachkie, James A L Miller, John T Kissel, Björn Oskarsson, Nanette C Joyce, Peter Van den Bergh, Jonathan Baets, Jan L De Bleecker, Chafic Karam, William S David, Massimiliano Mirabella, Sharon P Nations, Hans H Jung, Elena Pegoraro, Lorenzo Maggi, Carmelo Rodolico, Massimiliano Filosto, Aziz I Shaibani, Kumaraswamy Sivakumar, Namita A Goyal, Madoka Mori-Yoshimura, Satoshi Yamashita, Naoki Suzuki, Masahisa Katsuno, Kenya Murata, Hiroyuki Nodera, Ichizo Nishino, Carla D Romano, Valerie S L Williams, John Vissing, Lixin Zhang Auberson, Min Wu, Ana de Vera, Dimitris A Papanicolaou, Anthony A Amato
BACKGROUND: Inclusion body myositis is an idiopathic inflammatory myopathy and the most common myopathy affecting people older than 50 years. To date, there are no effective drug treatments. We aimed to assess the safety, efficacy, and tolerability of bimagrumab-a fully human monoclonal antibody-in individuals with inclusion body myositis. METHODS: We did a multicentre, double-blind, placebo-controlled study (RESILIENT) at 38 academic clinical sites in Australia, Europe, Japan, and the USA...
September 2019: Lancet Neurology
#18
JOURNAL ARTICLE
Tobias Lange, Katja Walpurgis, Andreas Thomas, Hans Geyer, Mario Thevis
Aim: sotatercept is a therapeutic Fc-fusion protein with erythropoiesis-stimulating activity. Due to a potential abuse of the drug by athletes in professional sports, a sensitive detection method is required. In sports drug testing, alternative matrices such as dried blood spots (DBS) are gaining increasing attention as they can provide several advantages over conventional matrices. Materials & methods: Herein, two complementary LC-high-resolution mass spectrometry (HRMS) detection methods for sotatercept from DBS, an initial testing procedure (ITP) and a confirmation procedure (CP) were developed and validated for the first time...
May 2019: Bioanalysis
#19
REVIEW
Mavroudis Ioannis, Petridis Foivos, Kazis Dimitrios
BACKGROUND: Sporadic inclusion body myositis is the most common inflammatory myopathy over the age of 50. The aetiopathogenesis of the disease remains unclear and to the day there is no effective treatment. OBJECTIVES: The aim of the present review is to present the latest data on the new insights and developments in the treatment of sporadic inclusion body myositis, focusing on Bimagrumab and Alemtuzumab. METHODS: For the purpose of the review we searched multiple internet databases in order to find the most recent studies and clinical trials on the safety, tolerability and efficacy of Bimagrumab and Alemtuzumab in sporadic inclusion body myositis...
March 2019: International Journal of Neuroscience
#20
RANDOMIZED CONTROLLED TRIAL
Michael I Polkey, Jens Praestgaard, Amy Berwick, Frits M E Franssen, Dave Singh, Michael C Steiner, Richard Casaburi, Hanns-Christian Tillmann, Estelle Lach-Trifilieff, Ronenn Roubenoff, Daniel S Rooks
RATIONALE: Bimagrumab is a fully human monoclonal antibody that blocks the activin type II receptors, preventing the activity of myostatin and other negative skeletal muscle regulators. OBJECTIVES: To assess the effects of bimagrumab on skeletal muscle mass and function in patients with chronic obstructive pulmonary disease (COPD) and reduced skeletal muscle mass. METHODS: Sixty-seven patients with COPD (mean FEV1 , 1.05 L [41.6% predicted]; aged 40-80 yr; body mass index < 20 kg/m2 or appendicular skeletal muscle mass index ≤ 7...
February 1, 2019: American Journal of Respiratory and Critical Care Medicine
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