Evaluating the safety of NNC4004-0002 for people with high uric acid levels

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

This study is testing a new drug called NNC4004-0002 to see if it can safely lower high uric acid levels in adults who don’t have symptoms.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 2 sites (Glendale, California and 1 other locations)
• Trial ID: NCT06859073 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of an investigational drug called NNC4004-0002 in adults with asymptomatic hyperuricemia. Participants will receive either the study drug or a saline placebo through injections, with the treatment assignment determined randomly. The primary goal is to assess how well the drug lowers serum uric acid levels and whether it is safe for human use. The study will last approximately 19 months, involving multiple assessments of health and safety.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 35 to 75 with elevated serum uric acid levels.

Not a fit: Patients who are pregnant, breastfeeding, or not using adequate contraception will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for managing high uric acid levels, potentially preventing related health issues.

How similar studies have performed: While this approach is novel as it involves a first-time human administration of NNC4004-0002, similar studies have shown promise in evaluating new treatments for hyperuricemia.

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.

Where this trial is running

Glendale, California and 1 other locations

• PAREXEL Glendale/LA EPCU — Glendale, California, United States (Not_yet_recruiting)
• PAREXEL Intl - EPCU-Baltimore — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Healthy Volunteers; Hyperuricemia