Status:
RECRUITING
Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers
Hepatic Steatosis
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and sus...
Eligibility Criteria
Inclusion
- Considered eligible 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.
- Male or female (of non-childbearing potential) aged 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) 25.0 to 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
- Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) greater than or equal to (\>=) 10 percent and liver stiffness greater than 8 kilopascal (kPa) as measured by FibroScan® (vibration-controlled transient elastography \[VCTE™\]).
- Additional inclusion criteria for participants in the open-label liver biopsy cohort apply:
- Alanine aminotransferase (ALT) in men greater than (\>) 30 units per liter (U/L), women \> 19 U/L
- Liverstiffness, measured by FibroScan® (VCTE) \> 8 kPa and less than (\<) 12 kPa
- Informed consent obtained at screening for a liver biopsy to be performed at baseline and post-treatment.
- Note: Participants with confirmed metabolic dysfunction-associated steatohepatitis (MASH), based on a prior liver biopsy, can be included in the open-label cohort.
Exclusion
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Any laboratory safety parameter, at screening, outside the extended laboratory ranges, and considered clinically significant per the principal investigator (see laboratory provided reference ranges for specific values). Of note, re-screening or re-sampling is NOT allowed if the individual has failed one of the exclusion criteria related to the following laboratory parameters:
- ALT \>= 3 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) \>= 3 × ULN
- Bilirubin \> 1.5 × ULN
- Estimated glomerular filtration rate (eGFR) \< 60 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening.
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 25 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06891365
Start Date
March 12 2025
End Date
January 25 2027
Last Update
March 24 2025
Active Locations (1)
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1
Parexel CPRU, Level 7
Harrow, United Kingdom, HA1 3UJ