Indexing hint: Randomized controlled trial · 2025
Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis.
Sanyal et al. 2025The New England journal of medicinecited by 778
PMID 40305708DOI 10.1056/nejmoa2413258PUB-40305708
Trial · Interventional
Active, not recruitingPhase 3Registry dataShort name ESSENCE
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia
1 trial · 1 ongoing
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.
Experimental
Semaglutide OW (once weekly )
Semaglutide administrated subcutaneously once weekly
Placebo comparator
Placebo
Placebo administrated subcutaneously once weekly
Outcomes the sponsor listed as primary.
Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
Time frame · From randomisation (week 0) to week 72
Count of subject
Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)
Time frame · From randomisation (week 0) to week 72
Count of subject
Part 2: Cirrhosis-free survival (Yes/No)
Time frame · From randomisation (week 0) to week 240
Count of subject
Change in body weight
Time frame · From randomisation (week 0) to week 72
Percentage
Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)
Time frame · From randomisation (week 0) to week 72
Count of subject
Change in SF-36 (Short Form 36) Bodily Pain
Time frame · From randomisation (week 0) to week 72
Score points
Change in body weight
Time frame · From randomisation (week 0) to week 240
Percentage
Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)
Time frame · From randomisation (week 0) to week 72
Count of subject
Change in histology-assessed liver collagen proportionate area
Time frame · From randomisation (week 0) to week 72
Ratio to baseline
Worsening in steatohepatitis (Yes/No)
Time frame · From randomisation (week 0) to week 72
Count of subject
Improvement in histology-assessed ballooning (Yes/No)
Time frame · From randomisation (week 0) to week 72
Count of subject
Improvement in histology-assessed inflammation (Yes/No)
Time frame · From randomisation (week 0) to week 72
Count of subject
Improvement in histology-assessed steatosis (Yes/No)
Time frame · From randomisation (week 0) to week 72
Count of subject
NASH resolution (ballooning of 0, inflammation of 0-1) and above or equal to 2point NAS reduction with no worsening of fibrosis
Time frame · From randomisation (week 0) to week 72
Count of subject
Progression of liver fibrosis in patients with F2 at baseline (Yes/No)
Time frame · From randomisation (week 0) to week 72
Count of subject
Progression of liver fibrosis
Time frame · From randomisation (week 0) to week 72
Count of subject
Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
Time frame · From randomisation (week 0) to week 240
Count of subject
Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)
Time frame · From randomisation (week 0) to week 240
Count of subject
Absence of histological evidence of NASH (Yes/No)
Time frame · From randomisation (week 0) to week 240
Count of subject
Changes in liver stiffness values assessed by transient elastography (FibroScan®)
Time frame · From randomisation (week 0) to week 72 and week 240
Ratio to baseline
Change in ELF (Enhanced Liver Fibrosis) score
Time frame · From randomisation (week 0) to week 72 and week 240
Logarithm
Change in ALT (alanine aminotransferase)
Time frame · From randomisation (week 0) to week 72 and week 240
Ratio to baseline
Change in AST (aspartate aminotransferase)
Time frame · From randomisation (week 0) to week 72 and week 240
Ratio to baseline
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2025
Sanyal et al. 2025The New England journal of medicinecited by 778
PMID 40305708DOI 10.1056/nejmoa2413258PUB-40305708
Indexing hint: Clinical trial · 2024
Newsome et al. 2024Alimentary pharmacology & therapeuticscited by 105
PMID 39412509PMC11599791DOI 10.1111/apt.18331PUB-39412509
1 study on this page
PubMed tag: none · 2026
Nakajima et al. 2026Journal of gastroenterology
PMID 42663669DOI 10.1007/s00535-026-02507-0PUB-42663669
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