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NNC0582-0001

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05624580A Study to Look at Safety and Tolerability of NNC0582-0001, How it is Transported Throughout the Body and How it Works in Healthy AdultsPHASE1 COMPLETED 56Nov 15, 2022Oct 16, 2025Dec 24, 20251 Austria
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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 — 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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