Non-alcoholic steatohepatitis MedDRA version: 20.1 Level: PT Classification code 10053219 Term: Non-alcoholic steatohepatitis System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Product Name: Semaglutide B 1 mg/ml NovoPen4
Pharmaceutical Form: Solution for injection
INN or Proposed INN: semaglutide
CAS Number: 910463-68-2
Other descriptive name: SEMAGLUTIDE
Concentration uni
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 described pre-screening activities which require a separate informed consent. 2. Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive) at the time of signing informed consent. 3. Histological evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. 4. A histological NAS > = 4 with a score of 1 or more in each sub-component of the score based on central pathologist evaluation. 5. NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 245 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: 1. Known or suspected abuse of alcohol (> 20 g/day for women or > 30 g/day for men), alcohol dependence* or narcotics. (* = assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)). 2. Diagnosis of type 1 diabetes according to medical records. 3. HbA1c > 10% at screening. 4. History or presence of pancreatitis (acute or chronic). 5. Calcitonin = 50 ng/L at screening. 6. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative. 7. Body Mass Index (BMI) = 25.0 kg/m^2 at the screening visit (visit 1). 8. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of semaglutide subcutaneous (s.c.) once daily versus placebo on histological resolution of non-alcoholic steatohepatitis (NASH).;Secondary Objective: 1. To investigate the dose-response relationship of three dose levels of semaglutide s.c. once daily (0.1 mg/day, 0.2 mg/day and 0.4 mg/day) on histological resolution of NASH. 2. To compare the effects of semaglutide s.c. once daily to placebo on liver-related histological parameters and biomarkers of NASH disease. ;Primary end point(s): NASH resolution without worsening of fibrosis (yes/no);Timepoint(s) of evaluation of this end point: After 72 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. At least one stage of liver fibrosis improvement with no worsening of NASH (yes/no) (worsening defined as an increase of at least one stage of either lobular inflammation or hepatocyte ballooning according to NASH clinical research network (CRN) criteria). 2. Change in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) (0-8) 3. Change in stage of fibrosis according to the Kleiner fibrosis classification (0-4) 4. Change in activity component of steatosis-activity-fibrosis (SAF) score (0-4) 5. Change in fasting plasma glucose (FPG) 6. Change in glycosylated haemoglobin A1c (HbA1c) 7. Change in serum enhanced liver fibrosis (ELF) ;Timepoint(s) of evaluation of this end point: 1. After 72 weeks 2. – 7. From baseline to week 72 | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Denmark, European Union, Finland, France, Greece, Japan, Netherlands, Russian Federation, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed