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A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat

Fatty Liver Disease

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 69

Participation Criteria

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.

Study Location

Altasciences
Altasciences
Montreal, Quebec
Canada

Contact Study Team

Study Sponsored By
Novo Nordisk A/S
Participants Required
More Information
Study ID: NCT07214870