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

NCT05624580 | Completed Phase 1

• 4 other identifiers: NN6582-4838U1111-1274-43162022-001813-382023-506928-83
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Measured as number of events.

  From dosing (Day 1) until End of Study visit (Week 52)

Secondary Outcomes (3)

• AUC0-∞: The area under the NNC0582-0001 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 NNC0582-0001 in plasma

  From dosing (Day 1) to 168 hours after dosing

• tmax: The time from dose administration to maximum plasma concentration of NNC0582-0001

  From dosing (Day 1) to 168 hours after dosing

Study Arms (6)

Single Dose 1: NNC0582-0001 10 milligram (mg)

EXPERIMENTAL

Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously.

Drug: NNC0582-0001; Drug: Placebo

Single Dose 2: NNC0582-0001 30 mg

EXPERIMENTAL

Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously.

Drug: NNC0582-0001; Drug: Placebo

Single Dose 3: NNC0582-0001 90 mg

EXPERIMENTAL

Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously.

Drug: NNC0582-0001; Drug: Placebo

Single Dose 4: NNC0582-0001 250 mg

EXPERIMENTAL

Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously.

Drug: NNC0582-0001; Drug: Placebo

Single Dose 5: NNC0582-0001 600 mg

EXPERIMENTAL

Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously.

Drug: NNC0582-0001; Drug: Placebo

Single Dose 6: NNC0582-0001 1000 mg

EXPERIMENTAL

Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously.

Drug: NNC0582-0001; Drug: Placebo

Interventions

NNC0582-0001 DRUG

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.

Single Dose 1: NNC0582-0001 10 milligram (mg); Single Dose 2: NNC0582-0001 30 mg; Single Dose 3: NNC0582-0001 90 mg; Single Dose 4: NNC0582-0001 250 mg; Single Dose 5: NNC0582-0001 600 mg; Single Dose 6: NNC0582-0001 1000 mg

Placebo DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.

Single Dose 1: NNC0582-0001 10 milligram (mg); Single Dose 2: NNC0582-0001 30 mg; Single Dose 3: NNC0582-0001 90 mg; Single Dose 4: NNC0582-0001 250 mg; Single Dose 5: NNC0582-0001 600 mg; Single Dose 6: NNC0582-0001 1000 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Clinical Trials Unit / Center for Medical Research

Graz, 8010, Austria

Location

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
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 22, 2022
• Study Start: November 15, 2022
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)