{"id":"doi:10.1111/apt.18331","kind":"article","title":"Semaglutide 2.4 mg in Participants With Metabolic Dysfunction-Associated Steatohepatitis: Baseline Characteristics and Design of the Phase 3 ESSENCE Trial","authors":["Newsome PN","Sanyal AJ","Engebretsen KA","Kliers I","Østergaard L","Vanni D","Bugianesi E","Rinella ME","Roden M","Ratziu V"],"author_count":10,"year":2024,"published":"2024-10-16","venue":"Alimentary pharmacology & therapeutics","cited_by":105,"doi":"10.1111/apt.18331","arxiv_id":null,"nct_id":null,"source_url":"https://doi.org/10.1111/apt.18331","archive_url":"https://space-kitty.com/papers/doi:10.1111/apt.18331","updated":null,"pmid":"39412509","pmcid":"PMC11599791","openalex_id":null,"pdf_url":"https://europepmc.org/articles/PMC11599791/pdf","abstract":"Background Semaglutide, a glucagon-like peptide-1 receptor agonist, has demonstrated potential beneficial effects in metabolic dysfunction-associated steatohepatitis (MASH). Aims To describe the trial design and baseline characteristics of the 'Effect of Semaglutide in Subjects with Non-cirrhotic Non-alcoholic Steatohepatitis' (ESSENCE) trial (NCT04822181). Methods ESSENCE is a two-part, phase 3, randomised, multicentre trial evaluating the effect of subcutaneous semaglutide 2.4 mg in participants with biopsy-proven MASH and fibrosis stage 2 or 3. The primary objective of Part 1 is to demonstrate that semaglutide improves liver histology compared with placebo. The two primary endpoints are: resolution of steatohepatitis and no worsening of liver fibrosis, and improvement in liver fibrosis and no worsening of steatohepatitis. The Part 2 objective is based on clinical outcomes. The current work reports baseline characteristics of the first 800 randomised participants which includes demographics, laboratory parameters, liver histology, non-invasive tests and presence of metabolic dysfunction-associated steatotic liver disease (MASLD) cardiometabolic criteria. Results Of 800 participants, 250 (31.3%) had fibrosis stage 2 and 550 (68.8%) had fibrosis stage 3. In the overall population, mean (standard deviation [SD]) age was 56 (11.6) years, 57.1% were female, mean (SD) body mass index was 34.6 (7.2) kg/m 2 , 55.5% had type 2 diabetes and > 99% had at least one MASLD cardiometabolic criterion according to the published definition. Conclusion The ESSENCE baseline population includes participants with clinically significant fibrosis stages 2 and 3. Although MASLD cardiometabolic criteria were not a requirement for study enrolment, almost all participants (> 99%) had at least one MASLD cardiometabolic criterion. Trial registration NCT04822181.","abstract_license":"CC-BY (article license as recorded by Europe PMC; abstract reproduced unmodified apart from markup removal)","license":"CC-BY","is_open_access":true,"peer_reviewed":null,"categories":[],"details":null,"provenance":"europepmc","attribution":"Abstract of \"Semaglutide 2.4 mg in Participants With Metabolic Dysfunction-Associated Steatohepatitis: Baseline Characteristics and Design of the Phase 3 ESSENCE Trial\" by Newsome PN, Sanyal AJ, Engebretsen KA et al., https://doi.org/10.1111/apt.18331, used under its Creative Commons Attribution license (CC-BY); markup removed, otherwise unmodified.","topics":[{"slug":"glp1-metabolic","name":"GLP-1 & Incretin Therapies","domain_slug":"medicine"}],"cited_in_dossiers":[]}