Research study on whether a combination of 2 medicines (NNC0194-0499 and Semaglutide) works in people with non-alcoholic steatohepatitis (NASH)

Phase 1

• Conditions: on-alcoholic steatohepatitis (NASH); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-506961-74-00
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 698

Inclusion Criteria

Aged = 18 years at the time of signing informed consent. In Republic of Korea, subjects must be aged = 19 years. In Japan, subjects must be aged = 20 years. In Singapore, subjects must be aged = 21 years., 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 Visit 1., Histological evidence of fibrosis stage 2, 3 or 4 according to the NASH CRN classification based on a central pathologist evaluation of the baseline liver biopsy., Histological non-alcoholic fatty liver disease (NAFLD) activity score (NAS) = 4 for subjects with F2/F3 or = 3 for subjects with F4 based on a central pathologist evaluation of the baseline liver biopsy. All subjects must have a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning.

Exclusion Criteria

Documented causes of chronic liver disease other than 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 more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at V2A., For subjects with F4, presence or history of gastro-oesophageal varices = grade 2 at V3. An oesophagogastroduodenoscopy performed no more than 52 weeks prior to V3 must be available at V3., Known or suspected excessive consumption of alcohol (>20 g/day for women or > 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire))., Treatment with vitamin E (at doses = 800 IU/day) or pioglitazone or medications approved for the 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 V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A., Treatment with GLP-1 RAs within 90 days prior to V2A. Subjects with a historical liver biopsy taken more than 90 days prior to V2A are excluded if they receive treatment with GLP-1 RAs from time of biopsy until 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 V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.

Study & Design

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