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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2027-05-14

Brief Summary

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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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Detailed Description

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Conditions

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Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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NNC4005-0001

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

Group Type EXPERIMENTAL

NNC4005-001

Intervention Type DRUG

NNC4005-0001 will be given as a single ascending dose via subcutaneous route

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matched to NNC4005-0001 will be given via subcutaneous route

Interventions

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NNC4005-001

NNC4005-0001 will be given as a single ascending dose via subcutaneous route

Intervention Type DRUG

Placebo

Placebo matched to NNC4005-0001 will be given via subcutaneous route

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No