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NNC4004-0002

Phase 1

Hyperuricemia | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Sep 24, 2025

NNC4004-0002 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

NNC4004-0002 clinical trials

NNC4004-0002 · 1 trial · 2 indications

Phase 1 1
NCT06859073A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic HyperuricemiaHealthy Volunteers
RECRUITING60 Analytics
PHASE1RECRUITING
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
Healthy VolunteersUnlock trial analytics

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 to 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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Frequently asked questions about NNC4004-0002

What is NNC4004-0002?

NNC4004-0002 is an investigational small molecule being developed by Novo Nordisk A/S for hyperuricemia, a metabolic condition involving elevated uric acid levels. It is currently in Phase 1 clinical development and has not been approved for any indication.

What is NNC4004-0002 used for?

NNC4004-0002 is being studied for the treatment of hyperuricemia. The only clinical trial to date is in participants with asymptomatic hyperuricemia, meaning elevated uric acid without symptoms. It is investigational and not approved for any use.

Who makes NNC4004-0002?

NNC4004-0002 is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the Phase 1 trial evaluating the drug in asymptomatic hyperuricemia.

What phase is NNC4004-0002 in?

NNC4004-0002 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory authority. The Phase 1 trial is currently recruiting participants.

What clinical trials is NNC4004-0002 in?

NNC4004-0002 is being evaluated in one Phase 1 trial, NCT06859073, titled a study to evaluate the safety of NNC4004-0002 in participants with asymptomatic hyperuricemia. The trial is recruiting, with an estimated enrollment of 60 participants in the United States.

How is the NNC4004-0002 trial designed?

The Phase 1 trial NCT06859073 is a randomized, double-blind, placebo-controlled study. It plans to enroll 60 participants aged 35 years and older, including healthy volunteers, with asymptomatic hyperuricemia. The trial is recruiting in the United States.