Healthy Volunteers, Hepatic Steatosis
Conditions
Brief summary
This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). 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
Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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 55 Years
Healthy volunteers
Yes
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
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From dosing (Day 1) until completion of the End of Study Visit at week 52 | Measured as number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose | From dosing (Day 1) to 168 hours after dosing | Measured in nanogram hour per mililiter (ng\*h/mL). |
| Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose | From dosing (Day 1) to 168 hours after dosing | Measured in nanogram per mililiter (ng/mL). |
| tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose | From dosing (Day 1) to 168 hours after dosing | Measured in Hours. |
Countries
United Kingdom
Outcome results
None listed