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NNC0537-1482

Phase 1

Healthy Volunteers | Small molecule | Cardiovascular |Novo Nordisk A/S|Last Updated: Jun 25, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06625307A Research Study on the Effects of NNC0537-1482 in Healthy Individuals When Injected Under the SkinPHASE1 COMPLETED 31Oct 3, 2024May 4, 2025Jun 25, 20251 Netherlands
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events (TEAE) in cohorts 1 and 2
From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 15

Number of events.

Number of treatment emergent adverse events (TEAE) in cohort 3
From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 22

Number of events.

Number of treatment emergent adverse events (TEAE) in cohorts 4, 5 and 6
From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 40

Number of events.

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0537-1482 Dose level 1EXPERIMENTALParticipants will be administered a single dose of dose level 1 of NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 2EXPERIMENTALParticipants will be administered a single dose of dose level 2 of NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 3EXPERIMENTALParticipants will be administered a single dose of dose level 3 of NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 4EXPERIMENTALParticipants will be administered a single dose of dose level 4 of NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 5EXPERIMENTALParticipants will be administered a single dose of dose level 5 of NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 6EXPERIMENTALParticipants will be administered a single dose of dose level 6 of NNC0537-1482 subcutaneously.
PlaceboPLACEBO_COMPARATORParticipants will be administered a single dose of Placebo matched to NNC0537-1482 subcutaneously
Interventions
NameTypeDescription
NNC0537-1482DRUGAdministered via subcutaneous route
PlaceboDRUGAdministered via subcutaneous route
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Eligibility Criteria
Age Range22 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or postmenopausal female. * Age 22-55 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) between 18.5 and 30.0 kilogram/meter per square (kg/m\^2) (both inclusive) at screening. * Considered eligible and generally healthy based on ...

Countries:Netherlands
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