Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-12

Study Completion Date

2027-01-25

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). NNC0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance. NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.

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Detailed Description

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Conditions

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Healthy Volunteers Hepatic Steatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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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Cohort 1: NNC0581-0001 (Dose 1)

Participants will receive a subcutaneous (s.c) injection of either NNC0581-0001 Dose 1 or a matching placebo once monthly.

Group Type EXPERIMENTAL

NNC0581-0001

Intervention Type DRUG

NNC0581-0001 will be administered subcutaneously.

Placebo (NNC0581-0001)

Intervention Type DRUG

Placebo matched to NNC0581-0001 will be administered subcutaneously.

Cohort 2: NNC0581-0001 (Dose 2)

Participants will receive a s.c injection of either NNC0581-0001 Dose 2 or a matching placebo once monthly.

Group Type EXPERIMENTAL

NNC0581-0001

Intervention Type DRUG

NNC0581-0001 will be administered subcutaneously.

Placebo (NNC0581-0001)

Intervention Type DRUG

Placebo matched to NNC0581-0001 will be administered subcutaneously.

Interventions

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NNC0581-0001

NNC0581-0001 will be administered subcutaneously.

Intervention Type DRUG

Placebo (NNC0581-0001)

Placebo matched to NNC0581-0001 will be administered subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* Male or female (of non-childbearing potential) aged 18-64 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) 25.0 to 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
* Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) greater than or equal to (\>=) 10 percent and liver stiffness greater than 8 kilopascal (kPa) as measured by FibroScan® (vibration-controlled transient elastography \[VCTE™\]).

* Alanine aminotransferase (ALT) in men greater than (\>) 30 units per liter (U/L), women \> 19 U/L
* Liverstiffness, measured by FibroScan® (VCTE) \> 8 kPa and less than (\<) 12 kPa
* Informed consent obtained at screening for a liver biopsy to be performed at baseline and post-treatment.

Note: Participants with confirmed metabolic dysfunction-associated steatohepatitis (MASH), based on a prior liver biopsy, can be included in the open-label cohort.

Exclusion Criteria

* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* ALT \>= 3 × upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \>= 3 × ULN
* Bilirubin \> 1.5 × ULN
* Estimated glomerular filtration rate (eGFR) \< 60 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No