Healthy Volunteers, Hepatic Steatosis
Conditions
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 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.
Interventions
DRUGNNC0581-0001
NNC0581-0001 will be administered subcutaneously.
Placebo matched to NNC0581-0001 will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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. 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From 1st dose (day 1) until completion of the end of study visit at week 52 | Measured as count of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-32h: The area under the NNC0581-0001 plasma concentration-time curve from time zero to 32 hours after each of the three doses | From dosing (day 1 in each treatment period) to 32 hours post dose | Measured in nanogram hour per mililitre (ng\*h/mL). |
| Cmax: The maximum concentration of NNC0581-0001 in plasma after each dose of three doses | From dosing (day 1 in each treatment period) to 32 hours post dose | Measured in nanogram per mililitre(ng/mL). |
| Tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after each dose of three doses | From dosing (day 1 in each treatment period) to 32 hours post dose | Measured in hours. |
Countries
United Kingdom
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed