Status:
RECRUITING
A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Fatty Liver Disease
Eligibility:
All Genders
18-69 years
Phase:
PHASE1
Brief Summary
The purpose of this clinical study is to find out if NNC4005-0001 is well-tolerated and safe for people who have increased body weight and increased liver fat. Participants will receive either NNC4005...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Aged 18-69 years (both inclusive) at the time of signing the informed consent.
- Body Mass Index (BMI) of 27.0-40.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening process.
- Hepatic fat fraction greater than or equal to (≥) 8% by magnetic resonance imaging proton density fat fraction (MRI-PDFF) within 17 days prior to dosing.
- No prior or present clinical history of metabolic dysfunction-associated steatohepatitis (MASH) diagnosis.
- Exclusion criteria:
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Previous or current use of therapies for MASH or antifibrotic therapies (authorised or within aclinical trial).
- Use of high-dose vitamin E \[greater than (\>) 800 international unit (IU) per day\], glucagon-like peptide-1 (GLP-1) agonists (such as liraglutide, dulaglutide, or semaglutide), glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 agonists (such as tirzepatide), or pioglitazone within 6 months prior to screening.
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels greater than or equal (≥) 1.5× Upper Limit of Normal (ULN) at screening.
- Total bilirubin levels \> 1.5 times ULN if direct bilirubin is within Normal Limits (WNL) at screening.
Exclusion
Key Trial Info
Start Date :
October 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 14 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07214870
Start Date
October 8 2025
End Date
May 14 2027
Last Update
November 3 2025
Active Locations (1)
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1
Altasciences
Montreal, Quebec, Canada, H3P 3P1