Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: NNC0194-0499: Dose: 7.5mg, 15mg, 30mg
Route of Administration: Subcutaneous
Duration of Therapy: 52 weeks
Intervention2: Placebo C: Dose: 7.5mg, 15mg, 30mg
Route of Administration: Subc
Sponsors
Novo Nordisk
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
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. • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in liver fibrosis and no worsening of NASHTimepoint: Week 0 to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Resolution of steatohepatitis and no worsening of liver fibrosisTimepoint: Week 0 to Week 52 | — |
Countries
Australia, Belgium, Bulgaria, Cameroon, Denmark, France, Germany, Greece, India, Italy, Japan, Malaysia, Netherlands, Poland, Republic of Korea, Russian Federation, Singapore, Spain, United Kingdom, United States of America
Contacts
Public ContactVijay Parthasarathy
Novo Nordisk India Pvt. Ltd.
Outcome results
None listed