Research study on whether semaglutide works in people with non-alcoholic steatohepatitis (NASH)
- Conditions
- Health Condition 1: K740- Hepatic fibrosis
- Registration Number
- CTRI/2021/03/032022
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Subjects are eligible to be included in the trial only if all of the following criteria apply:
1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial except for protocol-defined pre-screening activities, which require a separate informed
consent. Ireland: See local requirements in Appendix 9 (Section 10.9).
2. Age above or equal to 18 years at the time of signing informed consent. Japan, South Korea
and Taiwan: See local requirements in Appendix 9 (Section 10.9).
3. 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).
4. 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.
5. 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.
China: See local requirements in Appendix 9 (Section 10.9).
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 (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 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 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 Resolution of steatohepatitis and no worsening of liver fibrosisa. <br/ ><br>Improvement in liver <br/ ><br>fibrosis and no worsening <br/ ><br>of steatohepatitis. <br/ ><br>Time to first liver-related clinical event <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Week 0 to Week 72 <br/ ><br> <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Progression of liver fibrosis <br/ ><br>Change in body weight <br/ ><br>Change in SF-36 Bodily Pain <br/ ><br>Timepoint: Week 0 to Week 72 <br/ ><br>Week 0 to Week 240 <br/ ><br>