First Human Dose Trial 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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-23

Study Completion Date

2025-08-29

Brief Summary

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This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). 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

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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Single Dose 1: NNC0581-0001 10 milligram (mg)

Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0581-0001

Intervention Type DRUG

Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.

Placebo (NNC0581-0001)

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Single Dose 2: NNC0581-0001 30 mg

Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0581-0001

Intervention Type DRUG

Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.

Placebo (NNC0581-0001)

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Single Dose 3: NNC0581-0001 90 mg

Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0581-0001

Intervention Type DRUG

Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.

Placebo (NNC0581-0001)

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Single Dose 4: NNC0581-0001 250 mg

Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0581-0001

Intervention Type DRUG

Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.

Placebo (NNC0581-0001)

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Single Dose 5: NNC0581-001 600 mg

Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0581-0001

Intervention Type DRUG

Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.

Placebo (NNC0581-0001)

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Single Dose 6: NNC0581-001 1000 mg

Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0581-0001

Intervention Type DRUG

Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.

Placebo (NNC0581-0001)

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Interventions

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NNC0581-0001

Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.

Intervention Type DRUG

Placebo (NNC0581-0001)

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) from 18.5 to 30.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
* Considered to be generally healthy 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.

* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) from 25.0 to 34.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
* Hepatic steatosis identified by a score above 248 dB/m by Fibroscan® (Controlled Attenuated Parameter, CAP) at screening.

Exclusion Criteria

* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Alanine aminotransferase (ALT) greater than upper normal limit (UNL) plus 10 percent
* Aspartate aminotransferase (AST) greater than UNL plus 10 percent
* Bilirubin greater than UNL plus 10 percent
* Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73 square meters (90 mL/min/1.73m\^2)
* Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimole per mole \[mmol/mol\]) at screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes