Status:
COMPLETED
A Study on How Semaglutide Works on Early Stages of Scar Tissue in the Liver Assessed by Pictures of the Liver
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Hepatobiliary Disorders
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is looking at the effect of semaglutide on subjects with nonalcoholic fatty liver disease.This study is comparing the change in early stages of scar tissue in the liver and fat deposition i...
Eligibility Criteria
Inclusion
- 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
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
- Liver steatosis greater than or equal to 10% measured by magnetic resonance imaging proton density fat fraction at screening
- Liver stiffness between 2.50 and 4.63 kPa (both inclusive) measured by magnetic resonance elastography at screening
- Body mass index between 25.0 and 40.0 kg/sqm (both inclusive) at the screening visit
Exclusion
- Known or suspected abuse of alcohol (greater than 12 g/day for women or greater than 24 g/day for men) or alcohol dependence assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)
- Diagnosis of type 1 diabetes according to medical records
- Glycosylated haemoglobin A1c (HbA1c) greater than 9.5% at screening
- History or presence of pancreatitis (acute or chronic) as declared by the subject
- Screening calcitonin greater than or equal to 100 ng/L
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods. (Highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence (only acceptable if corresponding to the preferred and usual lifestyle of the subject) or a surgically sterilised partner)
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2020
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03357380
Start Date
November 28 2017
End Date
March 20 2020
Last Update
November 22 2021
Active Locations (2)
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1
Novo Nordisk Investigational Site
Mainz, Germany, 55116
2
Novo Nordisk Investigational Site
Neuss, Germany, 41460