First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases
About the study
Who can take part
INCLUSION CRITERIA
Inclusion Criteria, for healthy participants in Part A:
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body Mass Index (BMI) from 18.5 to 30.0 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Inclusion criteria for participants with hepatic steatosis in Part B:
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body Mass Index (BMI) from 25.0 to 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- Hepatic steatosis identified by a score above 248 dB/m by Fibroscan® (Controlled Attenuated Parameter, CAP) at screening.
EXCLUSION CRITERIA
Exclusion Criteria
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Alanine aminotransferase (ALT) greater than upper normal limit (UNL) plus 10 percent
- Aspartate aminotransferase (AST) greater than UNL plus 10 percent
- Bilirubin greater than UNL plus 10 percent
- Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73 square meters (90 mL/min/1.73m^2)
- Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimole per mole [mmol/mol]) at screening.
* For Part A: Any laboratory safety parameters at screening outside the below laboratory ranges, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters):
Study Locations
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How to Apply
Study Details
Contition
Healthy Volunteers,Hepatic Steatosis
Age
18 - 55
Phase
PHASE1
Participants Needed
48
Est. Completion Date
Aug 28, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Novo Nordisk A/S
ClinicalTrials.gov NCT Identifier
NCT05599945
Study Number
NN6581-4860
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