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NCT Number: NCT06891365

Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Research Unit

Harrow, HA1 3UJ, United Kingdom

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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 exclusion criteria related to the following laboratory parameters:
  • ALT >= 3 × upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) >= 3 × ULN
  • Bilirubin > 1.5 × ULN
  • Estimated glomerular filtration rate (eGFR) < 50 milliliter per minute per 1.73 square meters (mL/min/1.73 m^2) at screening.

Additional exclusion criteria for participants in the open-label liver biopsy group apply:

  • Medical history of abnormal bleeding
  • BMI > 34.9 kilograms per square meters (kg/m^2)
  • Presence of ascites
  • Cirrhosis based on screening tests or historical biopsy
  • Lab abnormalities of platelets count < 150 × 10^9 per liter or International Normalized Ratio (INR) > 1.2
  • Concomitant use of medication:
  • anticoagulants or herbal supplements with an anticoagulative effect (as judged by the principal investigator)
  • antiplatelet medications
  • exception for aspirin that must be stopped 5 days prior to procedure and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) that must not be taken within 3 days of the procedure.

Treatment and study plan

NNC0581-0001

Drug

NNC0581-0001 will be administered subcutaneously.

Placebo (NNC0581-0001)

Drug

Placebo matched to NNC0581-0001 will be administered subcutaneously.

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From 1st dose (day 1) until completion of the end of study visit at week 52

    Measured as count of events.

Secondary 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

    Time frame: From dosing (day 1 in each treatment period) to 32 hours post dose

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

  2. Cmax: The maximum concentration of NNC0581-0001 in plasma after each dose of three doses

    Time frame: From dosing (day 1 in each treatment period) to 32 hours post dose

    Measured in nanogram per mililitre(ng/mL).

  3. Tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after each dose of three doses

    Time frame: From dosing (day 1 in each treatment period) to 32 hours post dose

    Measured in hours.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of NNC0581-0001 in Participants With Hepatic Steatosis and Suspected Steatohepatitis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2025
Registry last updated
Apr 7, 2026

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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