NCT06859073 · Novo Nordisk A/S
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
What this study is about
This study will evaluate an experimental drug called NNC4004-0002. "experimental" 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.
View original scientific description
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.
Interventions
DRUG
NNC4004-0002
NNC4004-0002 will be given as a single ascending dose via subcutaneous route.
DRUG
Placebo
Placebo matched to NNC4004-0002 will be given via subcutaneous route.
Primary outcome measures
Number of Treatment-emergent adverse event (TEAEs)
Time frame: From dosing (day 1) until end of study (approximately 28 weeks)
Count
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Glendale, California
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2025 · Source of record for eligibility and locations