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

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Fatty Liver Disease

Treatments: Drug: Placebo; Drug: NNC4005-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07214870

NN4005-8221

UTN (Other Identifier)

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

NNC4005-0001

Experimental group

Description:

Participants will receive a single dose of NNC4005-0001 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.

Treatment:

Drug: NNC4005-001

Placebo

Placebo Comparator group

Description:

Participants in each cohort will receive placebo matched to NNC4005-0001 injected subcutaneously.

Treatment:

Drug: Placebo