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Research Study for NNC4004-0002 in Asymptomatic Hyperuricemia

This study is testing a new, unapproved drug called NNC4004-0002 for the first time in humans. It's for people aged 35 to 75 who have asymptomatic hyperuricemia (high uric acid levels without symptoms) and are otherwise healthy. The main goal is to see if NNC4004-0002 is safe and tolerated after a single dose, and if it can lower uric acid. You would either receive NNC4004-0002 or a placebo (an inactive substance like saline), decided by chance. This study plans to enroll 60 participants, but its current recruitment status is unclear.

Study design
This is an interventional study where 60 participants will be randomly assigned to receive either NNC4004-0002 or a placebo.
What's involved
You would receive a single dose of the study medicine via subcutaneous (under the skin) injection and be monitored until the end of the study, approximately 28 weeks later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events (side effects) from the day of dosing until approximately 28 weeks after.

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NCT06859073

A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia

Recruiting
PHASE1Ages 35–75InterventionalTreatment
Novo Nordisk A/S
~60 participants
Updated 2025-09-24 on ClinicalTrials.gov
What's tested:NNC4004-0002Placebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Treatment-emergent adverse event (TEAEs)
Measured over From dosing (day 1) until end of study (approximately 28 weeks)

Conditions

Healthy Volunteers
Hyperuricemia

Explore related trials

Hyperuricemia

Where it's being run

2 sites across 2 states
California1
Maryland1

Study leadership

  • Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

Novo Nordisk
[email protected]
(+1) 866-867-7178
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 during the screening visit, as judged by the investigator.
Body mass index (BMI) 20 to 35 kilogram per meter square (kg/m2) (both inclusive) at screening.
Serum uric acid levels greater than or equal to (≥) 6.8 miligram per decileter (mg/dL) to less than or equal (≤) 12 mg/dL on 2 consecutive screening samples (the first at the screening visit \[V1\], and the second taken at V2 \[day -1\]; samples at least 7 days apart).

Exclusion

Female who is pregnant, breastfeeding, or intends to become pregnant or is of childbearing po-tential and not using an adequate contraceptive method.
Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
Present or prior history of gout, or present or prior use of serum Uric acid (sUA) lowering medication.
Serious cardiovascular or hepatic disease, current or past malignancies, or chronic debilitating neurologic, gastrointestinal, or inflammatory diseases.
History or current diagnosis of chronic history kidney disease.
Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) values greater than (\>) 2 multiply by (×) upper limit normal (ULN) or total bilirubin \>1.5× ULN.

What this trial measures

  • Number of Treatment-emergent adverse event (TEAEs)From dosing (day 1) until end of study (approximately 28 weeks)

    Count