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NNC4004-0002

Phase 1

Healthy Volunteers | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Sep 24, 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

Clinical trial landscape

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 Volunteers
NCT0685907360
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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 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 used for?

NNC4004-0002 is an investigational small molecule being developed by Novo Nordisk for metabolic conditions. It is currently in a Phase 1 clinical trial evaluating its safety in participants with asymptomatic hyperuricemia, a condition of elevated uric acid levels without symptoms. The study also includes healthy volunteers.

Who makes NNC4004-0002?

NNC4004-0002 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the NYSE under the ticker NVO. The company is conducting a Phase 1 clinical trial to evaluate the safety of this investigational small molecule in participants with asymptomatic hyperuricemia.

What phase is NNC4004-0002 in?

NNC4004-0002 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the safety of the drug in individuals with asymptomatic hyperuricemia and healthy volunteers.

What clinical trials is NNC4004-0002 in?

NNC4004-0002 is being studied in one Phase 1 clinical trial, identified as NCT06859073. This randomized, double-blind, placebo-controlled study is recruiting 60 participants in the United States to evaluate the safety of NNC4004-0002 in individuals with asymptomatic hyperuricemia and healthy volunteers aged 35 years and older.

Is NNC4004-0002 being studied in healthy volunteers?

Yes, NNC4004-0002 is being studied in healthy volunteers as part of its Phase 1 clinical trial. The study, NCT06859073, includes both healthy volunteers and participants with asymptomatic hyperuricemia. The trial is recruiting 60 participants in the United States and is designed to evaluate the safety of the drug.