Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial
- Conditions
- non-alcoholic steatohepatitis
- Registration Number
- JPRN-jRCT2031210294
- Lead Sponsor
- Okada Kahori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy.
-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.
-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.
-Presence or history of gastro-oesophageal varices >=grade 2 at V2A. For subjects with F4, an oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2A must be available at V2A.
-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)).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in liver fibrosis and no worsening of NASH
- Secondary Outcome Measures
Name Time Method Resolution of steatohepatitis and no worsening of liver fibrosis<br>Number of treatment emergent adverse events