A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
Recruiting · NCT07214870 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
NNC4005-001Placebo
What this trial is about
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 NNC4005-0001, which is the treatment being tested, or a placebo, which is a treatment that contains no active medicine. The study will last for about for about 7 to 8 months.
Who can take part
Age range
18 Years to 69 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Altasciences Clinical Company, Inc - Montreal, Quebec, Canada