NCT05599945

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2022

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

November 23, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2025

Completed
Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

2.8 years

First QC Date

October 26, 2022

Last Update Submit

October 8, 2025

Conditions

Healthy VolunteersHepatic Steatosis

Outcome Measures

Primary Outcomes (1)

  • Number of treatment emergent adverse events (TEAEs)

    Measured as number of events.

    From dosing (Day 1) until completion of the End of Study Visit at week 52

Secondary Outcomes (3)

  • AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose

    From dosing (Day 1) to 168 hours after dosing

  • Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose

    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

    From dosing (Day 1) to 168 hours after dosing

Study Arms (6)

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

EXPERIMENTAL

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

Drug: NNC0581-0001Drug: Placebo (NNC0581-0001)

Single Dose 2: NNC0581-0001 30 mg

EXPERIMENTAL

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

Drug: NNC0581-0001Drug: Placebo (NNC0581-0001)

Single Dose 3: NNC0581-0001 90 mg

EXPERIMENTAL

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

Drug: NNC0581-0001Drug: Placebo (NNC0581-0001)

Single Dose 4: NNC0581-0001 250 mg

EXPERIMENTAL

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

Drug: NNC0581-0001Drug: Placebo (NNC0581-0001)

Single Dose 5: NNC0581-001 600 mg

EXPERIMENTAL

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

Drug: NNC0581-0001Drug: Placebo (NNC0581-0001)

Single Dose 6: NNC0581-001 1000 mg

EXPERIMENTAL

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

Drug: NNC0581-0001Drug: Placebo (NNC0581-0001)

Interventions

NNC0581-0001DRUG

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

Single Dose 1: NNC0581-0001 10 milligram (mg)Single Dose 2: NNC0581-0001 30 mgSingle Dose 3: NNC0581-0001 90 mgSingle Dose 4: NNC0581-0001 250 mgSingle Dose 5: NNC0581-001 600 mgSingle Dose 6: NNC0581-001 1000 mg
Placebo (NNC0581-0001)DRUG

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

Single Dose 1: NNC0581-0001 10 milligram (mg)Single Dose 2: NNC0581-0001 30 mgSingle Dose 3: NNC0581-0001 90 mgSingle Dose 4: NNC0581-0001 250 mgSingle Dose 5: NNC0581-001 600 mgSingle Dose 6: NNC0581-001 1000 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Parexel CPRU, Level 7

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Parexel Research Unit

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Clinical Transparency dept. 2834

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

October 31, 2022

Study Start

November 23, 2022

Primary Completion

August 29, 2025

Study Completion

August 29, 2025

Last Updated

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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

Locations

GB(2)