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Clinical Trial ● Currently Recruiting Phase I NCT06891365

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

Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases — Recruiting • Phase I • Gastroenterology • NCT06891365.

📅 07 Apr 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase I
NCT ID
NCT06891365
Sponsor
Novo Nordisk A/S
Start
2025-03-12
ClinicaliQ Trial Snapshot
  • Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases — Recruiting • Phase I • Gastroenterology • NCT06891365.
  • 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….
  • Sponsor: Novo Nordisk A/S.

Verify eligibility, endpoints and current status on the original source registry before acting on this summary.

Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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.

Eligibility Snapshot
  • : * 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 (= 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

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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