For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
  2. Body Mass Index (BMI) from 20.0 to 30.0 kilogram per square meter (kg/m^2) (both inclusive) at screening.
  3. 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:

  1. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  2. Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimoles per mole [mmol/mol]) at screening.
  3. 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):

  4. Alanine aminotransferase (ALT)
  5. Aspartate aminotransferase (AST)
  6. Bilirubin
  7. Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73m^2 (mL/min/1.73m^2)
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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Healthy Volunteers

Age (in years)

18 - 55


Phase 1

Participants needed


Est. Completion Date

Jun 2, 2025

Treatment type



Novo Nordisk A/S identifier


Study number


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