A Study to Look at Safety and Tolerability of NNC0582-0001, How it is Transported Throughout the Body and How it Works in Healthy Adults

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injections of NNC0582-0001 in Healthy Adults

This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single subcutaneous administrations of NNC0582-0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0582 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: NNC0582-0001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Clinical Trials Unit / Center for Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 20.0 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.

Exclusion Criteria:

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimoles per mole [mmol/mol]) at screening.
• Any of the below laboratory safety parameters at screening outside normal range, 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)
• Aspartate aminotransferase (AST)
• Bilirubin
• Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73m^2 (mL/min/1.73m^2)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Dose 1: NNC0582-0001 10 milligram (mg); Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously.	Drug: NNC0582-0001; Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.; Drug: Placebo; Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.
Experimental: Single Dose 2: NNC0582-0001 30 mg; Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously.	Drug: NNC0582-0001; Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.; Drug: Placebo; Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.
Experimental: Single Dose 3: NNC0582-0001 90 mg; Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously.	Drug: NNC0582-0001; Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.; Drug: Placebo; Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.
Experimental: Single Dose 4: NNC0582-0001 250 mg; Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously.	Drug: NNC0582-0001; Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.; Drug: Placebo; Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.
Experimental: Single Dose 5: NNC0582-0001 600 mg; Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously.	Drug: NNC0582-0001; Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.; Drug: Placebo; Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.
Experimental: Single Dose 6: NNC0582-0001 1000 mg; Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously.	Drug: NNC0582-0001; Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.; Drug: Placebo; Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAEs)	Measured as number of events.	From dosing (Day 1) until End of Study visit (Week 52)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax: The maximum concentration of NNC0582-0001 in plasma	Measured in nanogram per mililiter (ng/mL).	From dosing (Day 1) to 168 hours after dosing
AUC0-∞: The area under the NNC0582-0001 plasma concentration-time curve from time zero to infinity after a single dose.	Measured in hours * nanogram per mililiter (h*ng/mL).	From dosing (Day 1) to 168 hours after dosing
tmax: The time from dose administration to maximum plasma concentration of NNC0582-0001	Measured in hours.	From dosing (Day 1) to 168 hours after dosing

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): October 16, 2025
• Study Completion (Actual): October 16, 2025

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NN6582-4838; U1111-1274-4316 (Other Identifier: World Health Organization (WHO)); 2022-001813-38 (EudraCT Number); 2023-506928-83 (Registry Identifier: European Medical Agency (EMA))

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