The lancet. Gastroenterology & hepatology

Safety and effectiveness of zalfermin with semaglutide in people with liver scarring from metabolic-related fatty liver disease: a phase 2 dose study

Updated

Abstract

This phase 2 study evaluated once-weekly zalfermin and semaglutide for efficacy and safety in patients with metabolic dysfunction-associated steatohepatitis.

  • The study focused on patients with clinically significant fibrosis, including those with compensated cirrhosis (F4c).
  • Efficacy and safety outcomes were assessed for both zalfermin and semaglutide.
  • Results may provide insights into treatment options for this patient population.

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Funding

Competing interests

Declaration of interests RL receives funding support from NCATS (5UL1TR001442) and NIDDK (U01DK061734, U01DK130190, R01DK106419, R01DK121378, R01DK124318, P30DK120515); serves as a consultant to Aardvark Therapeutics, Altimmune, Anylam/Regeneron, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Bristol Myers Squibb, CohBar, Eli Lilly, Galmed Pharmaceuticals, Gilead, Glympse Bio, Hightide, Inipharma, Intercept, Inventiva, Ionis, Janssen, Madrigal Pharmaceuticals, Metacrine, NGM Biopharmaceuticals, Novartis, Novo Nordisk, Merck, Pfizer, Sagimet, Theratechnologies, 89bio, Terns Pharmaceuticals, and Viking Therapeutics; received research grants to institution from Arrowhead Pharmaceuticals, AstraZeneca, and Terns Pharmaceuticals; and is a co-founder of LipoNexus, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galectin Therapeutics, Galmed Pharmaceuticals, Gilead, Intercept, Hanmi, Inventiva, Ionis, Janssen, Madrigal Pharmaceuticals, Merck, NGM Biopharmaceuticals, Novo Nordisk, Pfizer, and Sonic Incytes. JG is supported by the Robert W Storr Bequest to the Sydney Medical Foundation, University of Sydney, a National Health and Medical Research Council of Australia (NHMRC) Program Grant (APP1053206), Investigator and MRFF grants (APP2032407; NCRI000183; APP2016215; APP 2010795; APP1196492), and a Cancer Institute, NSW grant (2021/ATRG2028). LC received consultancies from Boehringer Ingelheim, Boston Pharmaceutical, Echosens, Gilead, GSK, Madrigal Pharmaceuticals, MSD, Novo Nordisk, Pfizer, Sagimet, and Siemens Healthineers and lecture fees from AstraZeneca, Boehringer Ingelheim, Echosens, Gilead, Novo Nordisk, Madrigal Pharmaceuticals, and Siemens Healthineers. SF is a lecturer for AbbVie, Allergan, Bayer, Eisai, Genfit, Gilead Sciences, Janssen Cilag, Intercept, Inventiva, MSD, Novo Nordisk, Promethera, and Siemens; has acted as consultant for AbbVie, Actelion, Aelin Therapeutics, Agomab Therapeutics, Aligos Therapeutics, Allergan, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Bristoll Meyers Squibb, CSL Behring, Coherus, Echosens, Eisai, Enyo, Galapagos, Galmed Pharmaceuticals, Genentech, Genfit, Genflow Bio, Gilead Sciences, Intercept, Inventiva, Janssen Pharmaceuticals, Julius Clinical, Madrigal Pharmaceuticals, MedImmune, MSD, NGM Biopharmaceuticals, Novartis, Novo Nordisk, PRO.MED.CS, Promethera, and Roche; and his institution has received grants from Astellas, Falk Pharma, Genfit, Gilead Sciences, Glympse Bio, Janssen Pharmaceuticals, Inventiva, MSD, Pfizer, and Roche. EL is a researcher for 89bio, Akero Therapeutics, Alnylam Pharmaceuticals, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cour Pharmaceuticals, Corcept Therapeutics, Eli Lilly, Enanta Pharmaceuticals, Enyo Pharma, Exalenz Bioscience, Galectin Therapeutics, Galmed Pharmaceuticals, Genfit, Gilead Sciences, GlaxoSmithKline, Hanmi Pharmaceuticals, Hightide Biopharma, Intercept, Inventiva, Ipsen, Janssen Pharmaceuticals, Madrigal Pharmaceuticals, Merck & Co, NGM Biopharmaceuticals, Northsea Therapeutics, Novartis, Novo Nordisk, Organovo, Poxel Co, Regeneron, Sagimet Biosciences, Takeda, Terns Pharmaceuticals, Viking Therapeutics, and Zydus Pharmaceuticals; is a speaker for AbbVie, Gilead Sciences, Intercept, Novo Nordisk, and Madrigal Pharmaceuticals; and is a consultant for 89bio, AstraZeneca, Boehringer Ingelheim, Corcept Therapeutics, Eli Lilly and Company, Inventiva, Merck & Co, Novo Nordisk, Organovo, Regeneron, and Sagimet Biosciences. AS, JOC, BA, and ABL are stockholders and employees of Novo Nordisk. BA is a patent holder for zalfermin. LLG received research support and speaker fees from Novo Nordisk, Pfizer, Becton Dickinson, Gilead, Sobi, Alexion, Immunovia, Norgine, and AstraZeneca.
PubMed

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