Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Non-alcoholic Steatohepatitis; Hepatobiliary Disorders

Treatments: Drug: Semaglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02970942

U1111-1179-7464 (Other Identifier)

NN9931-4296

2016-000685-39 (EudraCT Number)

Details and patient eligibility

About

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis

Enrollment: 320 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 6 patient groups, including a placebo group

Semaglutide 0,1 mg

Experimental group

Treatment:

Drug: Semaglutide

Semaglutide 0,2 mg

Experimental group

Treatment:

Drug: Semaglutide

Semaglutide 0,4 mg

Experimental group

Treatment:

Drug: Semaglutide

Placebo 1

Placebo Comparator group

Treatment:

Drug: Placebo

Placebo 2

Placebo Comparator group

Treatment:

Drug: Placebo

Placebo 3

Placebo Comparator group

Treatment:

Drug: Placebo