Actively Recruiting
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
Led by Novo Nordisk A/S · Updated on 2025-09-24
60
Participants Needed
2
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females 35 to 75 years of age at the time of signing the informed consent form (ICF).
- Generally healthy based on medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory tests as judged by the investigator.
- Body mass index (BMI) between 20 and 35 kg/m2 at screening.
- Serum uric acid levels between 6.8 and 12 mg/dL on two consecutive screening samples at least 7 days apart.
You will not qualify if you...
- Female who is pregnant, breastfeeding, or intends to become pregnant or is of childbearing potential and not using adequate contraception.
- Male of reproductive age who, or whose female partner(s), is not using adequate contraception.
- Present or prior history of gout or prior use of serum uric acid lowering medication.
- Serious cardiovascular or liver disease, current or past cancer, or chronic debilitating neurologic, gastrointestinal, or inflammatory diseases.
- History or current diagnosis of chronic kidney disease.
- Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) values greater than 2 times the upper limit normal (ULN) or total bilirubin greater than 1.5 times ULN.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
PAREXEL Glendale/LA EPCU
Glendale, California, United States, 91206
Not Yet Recruiting
2
PAREXEL Intl - EPCU-Baltimore
Baltimore, Maryland, United States, 21225
Actively Recruiting
Research Team
N
Novo Nordisk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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