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NCT Number: NCT06859073

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

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.

Recruiting

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PAREXEL Glendale/LA EPCU, Glendale, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC4004-0002

Drug

NNC4004-0002 will be given as a single ascending dose via subcutaneous route.

Placebo

Drug

Placebo matched to NNC4004-0002 will be given via subcutaneous route.

Primary outcomes

  1. Number of Treatment-emergent adverse event (TEAEs)

    Time frame: From dosing (day 1) until end of study (approximately 28 weeks)

    Count

Secondary outcomes

  1. AUC(0-72): The area under the NNC4004-0002 plasma concentration-time curve from time zero to the 72 hours after a single dose

    Time frame: From dosing (day 1) to 72 hours postdose

    microgram•hour/mililiter (μg•h/mL)

  2. Cmax: The maximum concentration of NNC4004-0002 in plasma

    Time frame: From dosing (day 1) to 72 hours postdose

    microgram/mililiter

  3. tmax: The time from dose administration to the maximum plasma concentration of NNC4004-0002

    Time frame: From dosing (day 1) to 72 hours postdose

    Hours

  4. Renal clearance

    Time frame: From time of dose to 72 hours postdose

    Liter/hour (L/h)

  5. Changes in serum Uric Acid (sUA) over time

    Time frame: From baseline through the end of the study (approximately 28 weeks)

    miligram/deciliter

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Phase 1, Double-blinded, Placebo-controlled Study of Single Ascending Doses of NNC4004-0002 in Adults With Asymptomatic Hyperuricemia

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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