Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis.A 72-week randomised, double-blind, placebo-controlled, six-armed parallel group, multi-centre, multinational trial

ovo Nordisk A/S0 sites372 target enrollmentNovember 25, 2016

Overview

No summary available.

Registry

who.int

Start Date

November 25, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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).