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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (1 UK site)
Parexel Research Unit
Harrow HA1 3UJ, United Kingdom
How to Get in Touch
Novo Nordisk
Sponsor contactCONTACT
