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Recruiting NCT06891365

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

Phase I Interventional Healthy Volunteers Hepatic Steatosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NNC0581-0001, Placebo (NNC0581-0001).
Who it may be relevant to
Registry conditions: Healthy Volunteers, Hepatic Steatosis. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug NNC0581-0001
    NNC0581-0001 will be administered subcutaneously.
  • Drug Placebo (NNC0581-0001)
    Placebo matched to NNC0581-0001 will be administered subcutaneously.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Parexel Research Unit — Harrow

Identifiers

NCT: NCT06891365 · NN6581-4981 · U1111-1298-9628

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗