The effect of semaglutide in non-cirrhotic non-alcoholic steatohepatitis
- Conditions
- non-alcoholic liver inflammationnon-alcoholic steatohepatitis10019654
- Registration Number
- NL-OMON54111
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
- 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 (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 both steatosis, lobular
inflammation and hepatocyte ballooning based on a central pathologist
evaluation of the baseline liver biopsy.
- Positive HBsAg, positive anti-HIV, positive HCV-RNA at screening or any known
presence of HCV RNA or HBsAg within 2 years of screening (V2A).
- Documented causes of chronic liver disease other than Non-Alcoholic Fatty
Liver Disease 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 (>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 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 (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.
- 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.
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint<br /><br>Part 1 (two separate endpoints):<br /><br>Resolution of steatohepatitis and no worsening of liver fibrosis - From<br /><br>randomisation (week 0) to week 72<br /><br>Improvement in liver fibrosis and no worsening of steatohepatitis - From<br /><br>randomisation (week 0) to week 72<br /><br><br /><br>Part 2:<br /><br>Time to first liver-related clinical event (composite endpoint) - From<br /><br>randomisation (week 0) to week 240</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary confirmatory endpoint<br /><br>Progression of liver fibrosis - From randomisation (week 0) to week 72<br /><br>Change in body weight - From randomisation (week 0) to week 72<br /><br>Change in SF-36 Bodily Pain - From randomisation (week 0) to week 72<br /><br>Change in body weight - From randomisation (week 0) to week 240</p><br>