Actively Recruiting
A Phase 1, Double-blinded, Placebo-controlled Study of Single Ascending Doses of NNC4004-0002 in Adults With Asymptomatic Hyperuricemia
Led by Novo Nordisk A/S · Updated on 2025-09-24
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an investigational drug called NNC4004-0002 to see if it can lower serum uric acid levels safely in adults with asymptomatic hyperuricemia. This is a Phase 1, double-blinded, placebo-controlled study where the safety and tolerability of a single dose of NNC4004-0002 will be tested for the first time in humans. The study aims to understand how the body handles this new medicine and its effects over time. Participants will receive either a single ascending dose of NNC4004-0002 or a matching placebo, both given as injections under the skin. The study includes up to six groups, each receiving different doses to assess safety and dose effects. Depending on the dose, participants may receive more than one injection. The study will last about 19 months in total, with each participant involved for approximately 7 months. During the study, participants will visit the clinic about 14 times, including a 4-night stay at the clinic. Researchers will monitor for any adverse events, measure the drug levels in the blood up to 72 hours after dosing, assess kidney clearance, and track changes in serum uric acid from baseline until about 28 weeks after dosing. Safety tests, physical exams, and lab tests will be conducted to ensure participant well-being throughout the study period.
CONDITIONS
Brief 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.
- Generally healthy based on medical history, physical exam, vital signs, electrocardiogram, and lab tests.
- 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 separate 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.
- History or current diagnosis of gout or prior use of uric acid lowering medication.
- Serious cardiovascular, liver, malignancy, neurological, gastrointestinal, or inflammatory diseases.
- History or current chronic kidney disease.
- Elevated liver enzymes (ALT or AST greater than 2 times upper limit normal) or total bilirubin over 1.5 times upper limit normal.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 day
Participants receive a single subcutaneous dose of NNC4004-0002 or placebo as part of one of up to 6 ascending dose cohorts.
1 dosing visit (in-person) and frequent assessments up to 72 hours postdose
Duration - Approximately 28 weeks
Participants are monitored for safety and changes in serum uric acid levels after dosing until the end of the study period.
Periodic visits during follow-up up to 28 weeks
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
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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