Research study on whether a combination of 2 medicines (NNC0194-0499 and semaglutide) works in people with non-alcoholic steatohepatitis (NASH)
- Conditions
- Health Condition 1: K740- Hepatic fibrosis
- Registration Number
- CTRI/2021/10/037678
- Lead Sponsor
- ovo Nordisk AS
- 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.
2. Aged = 18 years at the time of signing informed consent. Japan, Republic of Korea and
Singapore: Please 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 V1.
4. 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.
5. Histological 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)).
• 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in liver fibrosis and no worsening of <br/ ><br>NASHTimepoint: Week 0 to Week 52
- Secondary Outcome Measures
Name Time Method Resolution of steatohepatitis and no worsening of liver <br/ ><br>fibrosisTimepoint: Week 0 to Week 52