Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Semaglutide D
: 0.5mg , 1mg, 2mg ,2.27mg & 3.2mg
Once Weekly (OW)
Subcutaneous till 5 years
Control Intervention1: Semaglutide Ia & Ib Placebo
: 0.5mg , 1mg, 2mg ,2.27mg & 3.2mg
Once W
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 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of steatohepatitis and no worsening of liver fibrosisa. Improvement in liver fibrosis and no worsening of steatohepatitis. Time to first liver-related clinical event Timepoint: Week 0 to Week 72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression of liver fibrosis Change in body weight Change in SF-36 Bodily Pain Timepoint: Week 0 to Week 72 Week 0 to Week 240 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactVijay Parthasarathy
Novo Nordisk India private Ltd
Outcome results
None listed