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

Phase 1

• Conditions: on-alcoholic steatohepatitis; MedDRA version: 22.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-23
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• 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 screening visit.
- Histological evidence of fibrosis stage 2 or stage 3 according to the NASH Clinical Research Network (CRN) classification 7 based on a central pathologist evaluation of the baseline liver biopsy.
- A histological non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS 7) equal to or above 4 with a score of 1 or more in both 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

- Positive hepatitis B surface antigen (HBsAg), positive anti-human immunodeficiency virus (HIV), positive hepatitis C virus-ribonucleic acid (HCV-RNA) at screening or any known presence of HCV RNA or HBsAg within 2 years of screening.
- Documented causes of chronic liver disease other than NAFLD.
- Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
- Known or suspected excessive consumption of alcohol (above 20 g/day for women or above 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire).
- Treatment with vitamin E (at doses equal to or above 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to the screening visit. 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.
- Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit. 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.
- 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. 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