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NNC4004-0002

Phase 1

Healthy Volunteers | Small molecule | Other |Novo Nordisk A/S|Last Updated: Sep 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06859073A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic HyperuricemiaPHASE1 RECRUITING 60 — — Nov 13, 2024Jun 1, 2026Sep 24, 20252 United States
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Study Endpoints
Primary Endpoints
Number of Treatment-emergent adverse event (TEAEs)
From dosing (day 1) until end of study (approximately 28 weeks)

Count

Secondary Endpoints
AUC(0-72): The area under the NNC4004-0002 plasma concentration-time curve from time zero to the 72 hours after a single dose
From dosing (day 1) to 72 hours postdose
Cmax: The maximum concentration of NNC4004-0002 in plasma
From dosing (day 1) to 72 hours postdose
tmax: The time from dose administration to the maximum plasma concentration of NNC4004-0002
From dosing (day 1) to 72 hours postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC4004-0002EXPERIMENTALParticipants will receive a single dose of NNC4004-0002 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.
PlaceboPLACEBO_COMPARATORParticipants in each cohort will receive placebo matched to NNC4004-0002 injected subcutaneously.
Interventions
NameTypeDescription
NNC4004-0002DRUGNNC4004-0002 will be given as a single ascending dose via subcutaneous route.
PlaceboDRUGPlacebo matched to NNC4004-0002 will be given via subcutaneous route.
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Eligibility Criteria
Age Range35 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Males or females 35 to 75 years of age at the time of signing the informed consent form (ICF). * Considered to be generally healthy based on medical history, physical examination, and the re-sults of vital signs, electrocardiogram, and clinical laboratory tests performed durin...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06859073primaryCompletionDate: changed
LOWMay 24, 2026NCT06859073studyFirstPostDate: changed