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

Launched by NOVO NORDISK A/S · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new experimental drug called NNC4004-0002, which is being tested to see if it can safely lower high levels of uric acid in the blood. High uric acid, or hyperuricemia, can sometimes lead to health issues, but in this study, participants do not have any symptoms related to it. This is the first time the drug will be given to humans, and the main goal is to find out if it is safe for adults aged 35 to 75 who meet certain health criteria. Participants will randomly receive either the new drug or a saline solution (a simple saltwater solution) through an injection under the skin.

To be eligible for this study, participants need to be generally healthy, have a body mass index (BMI) between 20 and 35, and have specific high uric acid levels. They will take part in the study for about 7 months, which includes around 14 visits to the clinic, with one visit requiring a 4-night stay at the clinic for monitoring. It's important to know that there are some restrictions, such as not being pregnant or having certain medical conditions. Overall, this research aims to gather important information on the safety of this new treatment.

Gender

ALL

Eligibility criteria

• 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.