Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Status: | Active, not recruiting |
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Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/31/2019 |
Start Date: | November 30, 2016 |
End Date: | April 2, 2020 |
This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once
daily versus placebo in subjects with non-alcoholic steatohepatitis
daily versus placebo in subjects with non-alcoholic steatohepatitis
Inclusion Criteria: - 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. - 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 - 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 - Histologic evidence of NASH based on central
pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH
fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central
pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20
g/day for women or above 30 g/day for men), alcohol dependence* or narcotics. (* = assessed
by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type
1 diabetes according to medical records - HbA1c above 10% at screening - History or
presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at
screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary
thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤
25.0 kg/sqm at the screening visit (visit 1) - 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)
We found this trial at
36
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