Evidence map›Paper›PMID 39412509›Full record

ArticleAlimentary pharmacology & therapeutics2024

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

Philip N Newsome, Arun J Sanyal, Kristiane A Engebretsen, Iris Kliers, Laura Østergaard, Denise Vanni, Elisabetta Bugianesi, Mary E Rinella, Michael Roden, Vlad Ratziu

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Alimentary pharmacology & therapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04822181 (The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis), which is not on this map. Cited by 79 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04822181 phase3active not recruitingnot on this map

The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis

TypeinterventionalSponsorNovo Nordisk A/SRan2021 to 2029Enrolled1,205ConditionsNon-alcoholic SteatohepatitisArmsSemaglutide, Placebo
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Pooled it
  6. Pooled it
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  9. Glucagon-Like Peptide-1 Receptor Agonists Improve MASH and Liver Fibrosis: A Meta-Analysis of Randomised Controlled Trials.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Review
  15. Article
  16. Nor-ursodeoxycholic acid in hepatobiliary diseases: A narrative review.World journal of gastrointestinal pharmacology and therapeutics · 2026
    Review
  17. Autophagy in MASLD: A Metabolic and Precision Medicine Perspective.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Review
  18. Article
  19. Review
  20. Review

19 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Philip N NewsomeRoger Williams Institute of Liver Studies, Faculty of Life Sciences and Medicine, King's College London and King's College Hospital, London, UK.ORCID 0000-0001-6085-3652
Arun J SanyalVCU School of Medicine, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Richmond, Virginia, USA.ORCID 0000-0001-8682-5748
Kristiane A EngebretsenNovo Nordisk A/S, Copenhagen, Denmark.
Iris KliersNovo Nordisk A/S, Copenhagen, Denmark.
Laura ØstergaardNovo Nordisk A/S, Copenhagen, Denmark.
Denise VanniNovo Nordisk A/S, Copenhagen, Denmark.
Elisabetta BugianesiDepartment of Medical Sciences, University of Turin, Turin, Italy.
Mary E RinellaDivision of Gastroenterology, Hepatology and Nutrition, University of Chicago, Chicago, Illinois, USA.
Michael RodenDepartment of Endocrinology and Diabetology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.ORCID 0000-0001-8200-6382
Vlad RatziuSorbonne Université, Institute for Cardiometabolism and Nutrition, Hospital Pitié-Salpêtrière, INSERM UMRS 1138 CRC, Paris, France.ORCID 0000-0002-3051-0111

Funding

Novo Nordisk A/S
6 · The paper itself

Abstract

backgroundSemaglutide, a glucagon-like peptide-1 receptor agonist, has demonstrated potential beneficial effects in metabolic dysfunction-associated steatohepatitis (MASH).

aimsTo describe the trial design and baseline characteristics of the 'Effect of Semaglutide in Subjects with Non-cirrhotic Non-alcoholic Steatohepatitis' (ESSENCE) trial (NCT04822181).

methodsESSENCE 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.

resultsOf 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

conclusionThe 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 registrationNCT04822181.

Indexed as

Glucagon-Like PeptidesNon-alcoholic Fatty Liver DiseaseAdultAgedClinical Trials, Phase III as TopicDouble-Blind MethodFemaleHumansHypoglycemic AgentsLiverLiver CirrhosisMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicSemaglutideGlucagon-Like PeptidesHypoglycemic AgentsSemaglutideESSENCEMASHMASLDsemaglutide

Identifiers

PMID39412509
PMCPMC11599791

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.