Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)
- Status
- Active not recruitingResults none
- Why it is watched
- non-weight indication: liver, addiction, mortality
- Who it enrolls
- age 18 Years to no upper limit; no BMI minimum stated; conditions: Non-alcoholic Steatohepatitis
- Interventions
- Semaglutide; Placebo
- Conditions
- Non-alcoholic Steatohepatitis
- Phase and size
- Phase 3 · 1205 participants
- Dates
- Start 2021-04-01
Primary completion 2029-04-25 - Sponsor
- Novo Nordisk A/S (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- 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
Published results in the collection
- Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated SteatohepatitisRandomized trial · 2025 · Study tier 1 · Different population · Benefit · Industry funded
02Eligibility
Who can take part
Inclusion Criteria: * Age above or equal to 18 years at the time of signing informed consent. * Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to the screening visit (V1). * Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN (Clinical Research Network) classification based on a central pathologist evaluation of the baseline liver biopsy. * A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal to 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy. Exclusion Criteria: * Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD) * Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A). * Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation. * Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)). * Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening. * Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A). * Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
03Change log
Registry changes
No changes recorded since the trial was added.