Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis.
- Conditions
- on-alcoholic steatohepatitisMedDRA version: 19.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-000685-39-FR
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 372
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. 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. Local histological diagnosis of NASH followed by histological confirmation 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 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 316
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56
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 > 9% 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 or = 45.0 kg/m^2 at the screening visit.
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method