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Looking for participantsPhase1

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

Sponsor: Novo Nordisk A/S

NCT ID: NCT06891365

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
NNC0581-0001 (drug), Placebo (NNC0581-0001) (drug)
How long the study runs
Study runs about 32 months (dates as stated)
About the drug or intervention
NNC0581-0001 — drug: NNC0581-0001 will be administered subcutaneously. · Placebo (NNC0581-0001) — drug: Placebo matched to NNC0581-0001 will be administered subcutaneously.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 64 Years
Who
All
Number of participants
48
Started
2025-03-12
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy volunteers
  • • Phase1 - 48 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 64 Years
  • • Diagnosed with healthy volunteers

Where?

  • • Harrow - Parexel Research Unit

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Healthy VolunteersHepatic Steatosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 64 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Male or female (of non-childbearing potential) aged 18-69 years (both inclusive) at the time of signing the informed...
  • ✓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...
  • ✓Additional inclusion criteria for participants in the everyone knows which treatment they get liver biopsy cohort apply:
  • ✓Alanine aminotransferase (liver enzymes) in men greater than (\>) 30 units per liter (U/L), women \> 19 U/L

Who cannot take part

  • ✗Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • ✗liver enzymes \>= 3 × upper limit of normal (ULN)
  • ✗Aspartate aminotransferase (liver enzymes) \>= 3 × ULN
  • ✗liver blood test \> 1.5 × ULN
  • ✗Estimated glomerular filtration rate (eGFR) \< 50 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) at...
See the full 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.

Where Is This Study? (1 UK site)

Parexel Research Unit

Harrow HA1 3UJ, United Kingdom

Recruiting

How to Get in Touch

Novo Nordisk

Sponsor contact

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-03