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Experimental uric acid drug enters first human tests

NCT ID NCT06859073

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests an experimental drug called NNC4004-0002 in 60 adults with high uric acid but no symptoms. Participants receive either the drug or a placebo as a single injection under the skin. The main goal is to check safety and how the body handles the drug, with a secondary focus on its ability to lower uric acid levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NNC4004-0002 (an experimental drug given as an injection under the skin)
What this could lead to
If this drug is safe and lowers uric acid effectively, it could point toward a new treatment for high uric acid levels, potentially reducing the risk of gout or kidney stones.
What could go wrong
This is a very early (Phase 1) trial with only 60 people, so the drug may not work or could have side effects. It is the first time this drug is given to humans, so safety is still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Hyperuricemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers Hyperuricemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • PAREXEL Glendale/LA EPCU

    NOT_YET_RECRUITING

    Glendale, California, 91206, United States

  • PAREXEL Intl - EPCU-Baltimore

    RECRUITING

    Baltimore, Maryland, 21225, United States

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