Lancet (London, England)

Safety and effectiveness of weekly pemvidutide compared to placebo for fatty liver disease linked to metabolism: 24-week results from a large, controlled trial

Updated

Abstract

MASH resolution without worsening of fibrosis was achieved in 58% of patients receiving 1·2 mg pemvidutide at 24 weeks.

  • In the placebo group, 20% of patients experienced MASH resolution without worsening of fibrosis.
  • The 1·8 mg pemvidutide group showed a 52% rate of MASH resolution without fibrosis worsening.
  • Fibrosis improvement without worsening of MASH was observed in 33% of patients receiving 1·2 mg pemvidutide and 36% of those receiving 1·8 mg pemvidutide.
  • Adverse events were reported in 78% of the 1·2 mg group and 81% of the 1·8 mg group, with most being mild to moderate.
  • Pemvidutide was well tolerated, with very few discontinuations due to adverse events.

Simplified

Full Text

Full text is available at the source.

Funding

Competing interests

Declaration of interests MN reports research support from Allergan, Altimmune, Akero, BI, BMS, Boston Pharma, Conatus, Corcept, Gilead, Galectin, Genfit, GSK, Kowa, Enanta, Madrigal, Eli Lilly, Merck, Novartis, Novo Nordisk, Rivus, Shire, Takeda, Terns, Viking and Zydus; consulting fees from Akero, Altimmune, Alligos, AstraZeneca, BI, Boston Pharma, Curve Bioscience, Cytodyn, GSK, Histoindex, Kryia, Eli Lilly, Madrigal, Merck, Novo Nordisk, OPKO, Rivus, Sagimet, Terns, and Takeda; speaking fees from Madrigal and Novo Nordisk; has leadership roles at the journal Clinical Gastroenterology and Hepatology (associate editor) and the American Association for the Study of Liver Diseases (chair of the metabolic dysfunction-associated steatotic liver disease special interest group); and stock in Rivus Pharma, OPKO, Kryia, and Akero. RL reports research support from Arrowhead Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galectin Therapeutics, Gilead, Intercept, Hanmi, Inventiva, Ionis, Janssen, John C Martin Foundation, Madrigal Pharmaceuticals, Merck, US National Institutes of Health, Novo Nordisk, Pfizer, Sonic Incytes, and Terns Pharmaceuticals; consulting fees from Aardvark Therapeutics, Altimmune, Arrowhead Pharmaceuticals, AstraZeneca, Cascade Pharmaceuticals, Eli Lilly, Gilead, Glympse Bio, Inipharma, Intercept, Inventiva, Ionis, Janssen, Lipidio, Madrigal, Neurobo, Novo Nordisk, Merck, Pfizer, Sagimet, 89 bio, Takeda, Terns Pharmaceuticals, and Viking Therapeutics; is the co-founder of LipoNexus; and has stock in Sagimet Biosciences. NA reports research support from 89bio, Akero Therapeutics, Arbutus Biopharma, AstraZeneca, BioAge, Boehringer Ingelheim, Bristol Myers Squibb, Corcept Therapeutics, Galectin Therapeutics, Genentech, Gilead Sciences, Hepagene Therapeutics, Intercept Pharmaceuticals, Inventiva Pharma, Ionis Pharmaceuticals, Ipsen, Eli Lilly, Madrigal Pharmaceuticals, Merck, NGM Biopharmaceuticals, NorthSea Therapeutics, Novo Nordisk, Perspectum, Pfizer, PharmaIN, Poxel, Regeneron, Viking Therapeutics, and Zydus; consulting fees from 89bio, AbbVie, Akero, Boehringer Ingelheim, Echosens, Fibronostics, Gilead Sciences, HistoIndex, Intercept Pharmaceuticals, Ipsen, LiverRight, Madrigal Pharmaceuticals, NorthSea Therapeutics, Novo Nordisk, Perspectum, Pfizer, Regeneron, and Sonic Incytes; and speaking fees from AbbVie, AstraZeneca, Echosens, Gilead Sciences, Ipsen, Madrigal Pharmaceuticals, Novo Nordisk, and Perspectum. NC reports research funding from Madrigal, Exact Sciences, and Boehringer Ingelheim; consulting fees from Madrigal, GSK, Altimmune, Chugai, Insitro, Zydus, Eccogene, Biomea, and Ipsen; and stock in Heligenics and Avant Sante. MYS reports research support from Akero Therapeutics, Altimmune, Allergan, 89bio, Intercept Pharmaceuticals, Hanmi Pharmaceuticals, Salix Pharmaceuticals, Madrigal Pharmaceuticals, Viking Therapeutics, NGM Biopharmaceuticals, Eli Lilly, and Boston Pharmaceuticals; and speaking fees from Madrigal Pharmaceuticals, Salix Pharmaceuticals, and Gilead Sciences. ST is an employee of Altimmune; has a patent pending with Altimmune; and holds stock and stock options in Altimmune. JAG is an employee of Altimmune, has received consulting fees from Altimmune; has received speaking fees from Gilead and Madrigal; has participated in a data safety monitoring board or advisory board with Surrozen and Escient; and holds stock in Altimmune. SU is an employee of Altimmune. JJS is an employee of Altimmune; has received travel support from Altimmune; has a patent pending with Altimmune; and holds stock and stock options in Altimmune. RB is an employee of Altimmune; has received travel support from Altimmune; and holds stock and stock options in Altimmune. OO is an employee of Altimmune. JY is an employee of Altimmune. SK is an employee of Altimmune. GN reports consulting fees from Boehringer Ingelhelm, Boston Pharmaceuticals, and Echosens. EM reports speaking fees from Gilead, AbbVie, Madrigal Pharmaceuticals, and Ipsen; monitoring or advisory board participation with Gilead, Madrigal, and Ipsen; and board membership with HMRI non-profit and Salernis Collegium. MSR is an employee of Altimmune; has received travel support from Altimmune; and holds stock and stock options in Altimmune. SKB is an employee of Altimmune; holds stock in and has received travel support from Altimmune; has received speaking fees from Altimmune and is a lead for the Altimmune scientific advisory board. MSH is an employee of Altimmune; has received travel support from Altimmune; has a patent pending with Altimmune; is an Altimmune company officer, and holds stock and stock options in Altimmune. SAH is deceased and was unable to provide a competing interest statement; to the best of our knowledge he had no competing interests.
PubMed

What Lands in Your Inbox Each Week:

  • 📚7 fresh studies
  • 📝plain-language summaries
  • direct links to original studies
  • 🏅top journal indicators
  • 📅weekly delivery
  • 🧘‍♂️always free