Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorNovo Nordisk A/S
About this trial
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 suspected inflammation). NNC0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance. NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.
Eligibility criteria
Qualifiers
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 18-69 years (both inclusive) at the time of signing the informed consent.
Body mass index (BMI) greater than or equal to (>=) 25.0 at screening.
Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) >= 10 percent at screening.
Disqualifiers
Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
ALT >= 3 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) >= 3 × ULN
Bilirubin > 1.5 × ULN
Trial design
Treatments tested in this trial
- NNC0581-0001
- Placebo (NNC0581-0001)
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov