Skip to main content
OpenTrials
Completed

NCT Number: NCT05624580

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trials Unit / Center for Medical Research

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

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

    Measured as number of events.

Secondary outcomes

  1. AUC0-∞: The area under the NNC0582-0001 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 hours * nanogram per mililiter (h*ng/mL).

  2. Cmax: The maximum concentration of NNC0582-0001 in plasma

    Time frame: From dosing (Day 1) to 168 hours after dosing

    Measured in nanogram per mililiter (ng/mL).

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

    Time frame: From dosing (Day 1) to 168 hours after dosing

    Measured in hours.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2022
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.