Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis.
- Conditions
- Non-alcoholic steatohepatitis10019654
- Registration Number
- NL-OMON47918
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
* Informed consent obtained before any trial-related activities.
* Male or female, aged 18-75 years (both inclusive)
* Histologic evidence of NASH based on central pathologist evaluation
* A histological NAS * 4 with a score of 1 or more in each sub-component of the score based on central pathologist evaluation.
* NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.
* Known or suspected abuse of alcohol, alcohol dependence or narcotics.
* Diagnosis of type 1 diabetes according to medical records.
* HbA1c > 10% at screening.
* History or presence of pancreatitis (acute or chronic).
* Calcitonin * 50 ng/L at screening.
* Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
* Body Mass Index (BMI) * 25.0 kg/m2 at the screening visit.
* Female who is pregnant, breast-feeding or intends to become pregnant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>NASH resolution without worsening of fibrosis after 72 weeks (yes/no)</p><br>
- Secondary Outcome Measures
Name Time Method <p>* At least one stage of liver fibrosis improvement with no worsening of NASH<br /><br>after 72 weeks (yes/no) (worsening defined as an increase of at least one stage<br /><br>of either lobular inflammation or hepatocyte ballooning according to NASH<br /><br>clinical research network (CRN) criteria).<br /><br>Change from baseline to week 72 in:<br /><br>* Non-alcoholic fatty liver disease (NAFLD) activity score (NAS) (0-8)<br /><br>* Stage of fibrosis according to the Kleiner fibrosis classification (0-4)<br /><br>* Activity component of steatosis-activity-fibrosis (SAF) score (0-4)<br /><br>* Fasting plasma glucose (FPG)<br /><br>* Glycosylated haemoglobin A1c (HbA1c)<br /><br>* Serum enhanced liver fibrosis (ELF)</p><br>