Actively Recruiting
Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases
Led by Novo Nordisk A/S · Updated on 2026-04-07
48
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible based on medical history, physical exam, vital signs, electrocardiogram, and lab tests as judged by the investigator
- Male or female (of non-childbearing potential) aged 18-69 years at consent
- Body mass index (BMI) of at least 25.0 at screening
- Liver fat content of 10% or higher measured by MRI-PDFF at screening
- For open-label liver biopsy cohort: ALT greater than 30 U/L in men or greater than 19 U/L in women
- For open-label liver biopsy cohort: Liver stiffness between 8 and less than 12 kPa measured by FibroScan� (VCTE)
- For open-label liver biopsy cohort: Informed consent for liver biopsy at baseline and post-treatment
- Participants with confirmed metabolic dysfunction-associated steatohepatitis (MASH) based on prior liver biopsy can join open-label cohort
You will not qualify if you...
- Any disorder that might jeopardize safety or protocol compliance
- Laboratory safety values outside extended ranges considered clinically significant
- ALT greater than or equal to 3 times upper limit of normal (ULN)
- AST greater than or equal to 3 times ULN
- Bilirubin greater than 1.5 times ULN
- Estimated glomerular filtration rate (eGFR) below 50 mL/min/1.73 m
- For open-label liver biopsy group: history of abnormal bleeding
- For open-label liver biopsy group: BMI over 34.9 kg/m
- For open-label liver biopsy group: presence of ascites
- For open-label liver biopsy group: cirrhosis based on tests or biopsy
- For open-label liver biopsy group: platelet count below 150 x 10/L or INR above 1.2
- Use of anticoagulants or herbal supplements with anticoagulant effects
- Use of antiplatelet medications (except aspirin which must be stopped 5 days before procedure)
- Use of NSAIDs within 3 days of procedure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Parexel Research Unit
Harrow, United Kingdom, HA1 3UJ
Actively Recruiting
Research Team
N
Novo Nordisk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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