First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases

October 8, 2025 updated by: Novo Nordisk A/S

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • Parexel CPRU, Level 7
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • Parexel Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria, for healthy participants in Part A:

  • 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.

Inclusion criteria for participants with hepatic steatosis in Part B:

  • 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.
  • For Part A: Any laboratory safety parameters at screening outside the below laboratory ranges, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters):
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: 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.
Drug: Placebo (NNC0581-0001)
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Experimental: 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.
Drug: 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.
Drug: Placebo (NNC0581-0001)
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Experimental: 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.
Drug: 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.
Drug: Placebo (NNC0581-0001)
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Experimental: 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.
Drug: 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.
Drug: Placebo (NNC0581-0001)
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Experimental: 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.
Drug: 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.
Drug: Placebo (NNC0581-0001)
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Experimental: 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.
Drug: 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.
Drug: Placebo (NNC0581-0001)
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of treatment emergent adverse events (TEAEs)
Time Frame: From dosing (Day 1) until completion of the End of Study Visit at week 52
Measured as number of events.
From dosing (Day 1) until completion of the End of Study Visit at week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose
Time Frame: From dosing (Day 1) to 168 hours after dosing
Measured in nanogram hour per mililiter (ng*h/mL).
From dosing (Day 1) to 168 hours after dosing
Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose
Time Frame: From dosing (Day 1) to 168 hours after dosing
Measured in nanogram per mililiter (ng/mL).
From dosing (Day 1) to 168 hours after dosing
tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose
Time Frame: From dosing (Day 1) to 168 hours after dosing
Measured in Hours.
From dosing (Day 1) to 168 hours after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN6581-4860
  • U1111-1274-4577 (Other Identifier: World Health Organization (WHO))
  • 2022-001359-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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