# Semaglutide 2.4 mg in Participants With Metabolic Dysfunction-Associated Steatohepatitis: Baseline Characteristics and Design of the Phase 3 ESSENCE Trial

Article · Newsome PN, Sanyal AJ, Engebretsen KA, Kliers I, Østergaard L, Vanni D, Bugianesi E, Rinella ME, Roden M, Ratziu V

- Archive id: doi:10.1111/apt.18331
- Published: 2024-10-16
- Venue: Alimentary pharmacology & therapeutics
- DOI: https://doi.org/10.1111/apt.18331
- PMID: 39412509
- PMCID: PMC11599791
- Citations: 105
- Source URL: https://doi.org/10.1111/apt.18331
- PDF: https://europepmc.org/articles/PMC11599791/pdf
- Provenance: europepmc

## 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 reproduced under CC-BY (article license as recorded by Europe PMC; abstract reproduced unmodified apart from markup removal)._

Topics: [GLP-1 & Incretin Therapies](https://space-kitty.com/topics/glp1-metabolic)

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