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OpenTrials
Completed

NCT Number: NCT05599945

First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel CPRU, Level 7, Harrow, Middlesex, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria related to laboratory parameters):
  • Alanine aminotransferase (ALT) greater than upper normal limit (UNL) plus 10 percent
  • Aspartate aminotransferase (AST) greater than UNL plus 10 percent
  • Bilirubin greater than UNL plus 10 percent
  • Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73 square meters (90 mL/min/1.73m^2)
  • Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimole per mole [mmol/mol]) at screening.

Treatment and study plan

NNC0581-0001

Drug

Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.

Placebo (NNC0581-0001)

Drug

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From dosing (Day 1) until completion of the End of Study Visit at week 52

    Measured as number of events.

Secondary outcomes

  1. AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose

    Time frame: From dosing (Day 1) to 168 hours after dosing

    Measured in nanogram hour per mililiter (ng*h/mL).

  2. Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose

    Time frame: From dosing (Day 1) to 168 hours after dosing

    Measured in nanogram per mililiter (ng/mL).

  3. tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose

    Time frame: From dosing (Day 1) to 168 hours after dosing

    Measured in Hours.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2022
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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