Survodutide Improves MASH Histology Across Doses in Phase 2
This dose-finding trial gives Gastroenterology / Hepatology pharmacists early efficacy and tolerability data for a dual glucagon receptor and GLP-1 receptor agonist in biopsy-confirmed metabolic dysfunction-associated steatohepatitis with fibrosis.
Survodutide shows promise in treating MASH without worsening fibrosis.
Metabolic dysfunction-associated steatohepatitis (MASH) is a significant driver of liver morbidity, and effective treatments are limited. Survodutide improved MASH in 62% of patients at 4.8 mg versus 14% with placebo, without worsening fibrosis. While promising, data on adverse events such as nausea and diarrhea highlight the need for further phase 3 trials to better assess safety and efficacy of survodutide. Survodutide shows potential in improving MASH without worsening fibrosis, warranting further study.
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Authors:Sanyal AJ, Bedossa P, Fraessdorf M, Neff GW, Lawitz E, Bugianesi E, Anstee QM, Hussain SA, Newsome PN, Ratziu V, Hosseini-Tabatabaei A, Schattenberg JM, Noureddin M, Alkhouri N, Younes R, 1404-0043 Trial Investigators
Citation:Sanyal AJ, Bedossa P, Fraessdorf M, et al. A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis. The New England journal of medicine. 2024;391(4):311-319. doi:10.1056/NEJMoa2401755
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Executive Summary
Study Design
Patient Population
Primary Outcomes
Secondary Outcomes & Safety Profile
Pharmacist Implications
Clinical Pearls
Limitations
Controversies & Evidence Gaps
Cost & Logistics
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