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

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

Recruiting
35-75 years
All
Phase 1

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Overview

This study will evaluate an investigational drug called NNC4004-0002. "Investigational" means NNC4004-0002 has not been approved for sale/ for clinical use or for the use described in this study/ by any regulatory authority. Its use in this study is experimental. This will be the first time that NNC4004-0002 will be given to human. This study will be testing the ability of the study medicine to lower serum uric acid. The main aim of this study will be to see if the new study medicine is safe and tolerated by the body after a single dose of study medicine in adults with asymptomatic hyperuricemia. Participants will either get NNC4004-0002 (the study medicine), or saline. Which treatment the participant get will be decided by chance. The participant will get the medicine as an injection under their skin. Depending on the dose they will receive, participant may need more than one injection. The study will last for about 19 months in total. The participant will take part in the study for about 7 months. Participant will have approximately 14 visits to the clinic and one of them will be a 4 night in-house stay.

Eligibility

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.

Study details
    Healthy Volunteers
    Hyperuricemia

NCT06859073

Novo Nordisk A/S

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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