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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
NNC0581-0001
DrugNNC0581-0001 will be administered subcutaneously.
Placebo (NNC0581-0001)
DrugPlacebo matched to NNC0581-0001 will be administered subcutaneously.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: NNC0581-0001 (Dose 1)Experimental treatment 2 interventions
Group B: Cohort 2: NNC0581-0001 (Dose 2)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of treatment emergent adverse events (TEAEs)
Measured as count of events.
Time frame
From 1st dose (day 1) until completion of the end of study visit at week 52Secondary outcomes
1
AUC0-32h: The area under the NNC0581-0001 plasma concentration-time curve from time zero to 32 hours after each of the three doses
Measured in nanogram hour per mililitre (ng\*h/mL).
Time frame
From dosing (day 1 in each treatment period) to 32 hours post dose2
Cmax: The maximum concentration of NNC0581-0001 in plasma after each dose of three doses
Measured in nanogram per mililitre(ng/mL).
Time frame
From dosing (day 1 in each treatment period) to 32 hours post dose3
Tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after each dose of three doses
Measured in hours.
Time frame
From dosing (day 1 in each treatment period) to 32 hours post doseSponsors and contacts
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Source ClinicalTrials.gov