LivingGLP1
Study S000511

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

Included trial: extracted dataClinicalTrials.gov record

Registration

Registration
NCT04822181
Acronym
ESSENCE
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
ACTIVE_NOT_RECRUITING
Enrollment
1205
Start
2021-04-01
Primary completion
2029-04-25
Lead sponsor
Novo Nordisk A/S
Conditions
Non-alcoholic Steatohepatitis
Interventions
DRUG:Semaglutide; DRUG:Placebo
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1244-3678; REGISTRY:2019-004594-44; REGISTRY:jRCT2031210033; NIH:2019

Registered primary outcomes

  • Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) [From randomisation (week 0) to week 72]
  • Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No) [From randomisation (week 0) to week 72]
  • Part 2: Cirrhosis-free survival (Yes/No) [From randomisation (week 0) to week 240]

Linked records (11)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0012908Semaglutide in Japanese participants with metabolic dysfunction-associated steatohepatitis: a subgroup analysis of the ESSENCE trial.
Nakajima A, Journal of gastroenterology
2026Randomized trialPMID 42663669DOIcites ClinicalTrials.gov:NCT04822181; registry reference DERIVED:42663669
R00456281701-P: Longitudinal Dynamics of Cardiometabolic Parameters in a MASH Population Stratified by Baseline Glycemia and Treated with Semaglutide: Post Hoc Insights from the ESSENCE Trial Part 1
Mary Rinella, Diabetes
2026Randomized trialDOIcites ClinicalTrials.gov:NCT04822181
R0053733Semaglutide in MASH with F2-F3 fibrosis: a holistic perspective on the ESSENCE phase 3 trial
Carlos Jose Pirola, Metabolism and Target Organ Damage
2026Randomized trialDOIcites ClinicalTrials.gov:NCT04822181
R0006026Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis.
Sanyal AJ, The New England journal of medicine
2025Randomized trialPMID 40305708DOIcites ClinicalTrials.gov:NCT04822181; registry reference DERIVED:40305708
R0018195Outbreak of metabolic dysfunction-associated steatohepatitis pharmacotherapies in 2024: From resmetirom to tirzepatide.
Huang R, Chinese medical journal
2025Randomized trialPMID 39654450DOIcites ClinicalTrials.gov:NCT04822181
R0037996S2805 The Use of Non-Invasive Tests to Characterise the Total Baseline Population in the Phase 3 Essence Trial
Laurent Castera, The American Journal of Gastroenterology
2025Randomized trialDOIcites ClinicalTrials.gov:NCT04822181
R0055235P1 Phase 3 ESSENCE trial evaluating semaglutide in metabolic dysfunction-associated steatohepatitis (MASH): part 1 results and secondary analysis
Philip Noel Newsome
2025Randomized trialDOIcites ClinicalTrials.gov:NCT04822181
R0003088Transforming steatotic liver disease management: The emerging role of GLP-1 receptor agonists.
Jensen EL, Hepatology communications
2024Narrative reviewPMID 39392766DOIcites ClinicalTrials.gov:NCT04822181; registry reference DERIVED:39392766
R0006820Semaglutide 2.4 mg in Participants With Metabolic Dysfunction-Associated Steatohepatitis: Baseline Characteristics and Design of the Phase 3 ESSENCE Trial.
Newsome PN, Alimentary pharmacology & therapeutics
2024ProtocolPMID 39412509DOIcites ClinicalTrials.gov:NCT04822181; registry reference RESULT:39412509
R0040528From cause to consequence: Insights into incident diabetes mellitus after hepatic steatosis
Manik Aggarwal, Clinical Liver Disease
2023OtherPMID 36938314DOIcites ClinicalTrials.gov:NCT04822181
R0049754Hepatic steatosis provides the terroir that promotes the development of cardiovascular risk factors and disease
Ian A.C. Rowe, Hepatology
2023Nonrandomized studyPMID 36738088DOIcites ClinicalTrials.gov:NCT04822181; registry reference DERIVED:36738088