Research study on whether semaglutide works in people with non-alcoholic steatohepatitis (NASH)

Phase 1

• Conditions: on-alcoholic steatohepatitis; MedDRA version: 24.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-004594-44-PL
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-23
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

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 classification
based on a central pathologist evaluation of the baseline liver biopsy.
• A histological NAS = 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 960
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

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 in 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified