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NNC0582-0001

Phase 1

Healthy Volunteers | Small molecule | Other |Novo Nordisk A/S|Last Updated: Dec 24, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

NNC0582-0001 · 1 trial · 1 indication

Phase 1 1
NCT05624580A Study to Look at Safety and Tolerability of NNC0582-0001, How it is Transported Throughout the Body and How it Works in Healthy AdultsHealthy Volunteers
COMPLETED56 Analytics
PHASE1COMPLETED
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
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAEs)
From dosing (Day 1) until End of Study visit (Week 52)

Measured as number of events.

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Dose 1: NNC0582-0001 10 milligram (mg)EXPERIMENTALParticipants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously.
Single Dose 2: NNC0582-0001 30 mgEXPERIMENTALParticipants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously.
Single Dose 3: NNC0582-0001 90 mgEXPERIMENTALParticipants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously.
Single Dose 4: NNC0582-0001 250 mgEXPERIMENTALParticipants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously.
Single Dose 5: NNC0582-0001 600 mgEXPERIMENTALParticipants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously.
Single Dose 6: NNC0582-0001 1000 mgEXPERIMENTALParticipants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously.

Interventions

NameTypeDescription
NNC0582-0001DRUGParticipants 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.
PlaceboDRUGParticipants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 th...

Countries:Austria
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Frequently asked questions about NNC0582-0001

What is NNC0582-0001?

NNC0582-0001 is an investigational small molecule being developed by Novo Nordisk A/S. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to assess its safety, tolerability, and how it is transported throughout the body.

What is NNC0582-0001 used for?

NNC0582-0001 is being studied in healthy volunteers as part of early clinical development. The completed Phase 1 trial focused on evaluating the safety, tolerability, and pharmacokinetics of the drug in healthy adults. Its intended therapeutic use has not been established.

Who makes NNC0582-0001?

NNC0582-0001 is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical research on this investigational small molecule.

What phase is NNC0582-0001 in?

NNC0582-0001 is in Phase 1 clinical development. A Phase 1 study has been completed, which enrolled 56 healthy adult participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is NNC0582-0001 in?

NNC0582-0001 has one completed clinical trial registered as NCT05624580. This Phase 1 study was conducted in Austria and enrolled 56 healthy adults. The trial was randomized, double-blind, and controlled, evaluating safety, tolerability, and how the drug is transported in the body.

Is NNC0582-0001 the same as any other drug?

NNC0582-0001 is the only name provided for this investigational drug. No alternative names have been established in the available clinical trial information.