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A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
Sponsor: Novo Nordisk A/S
Summary
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.
Official title: A Phase 1, Double-blinded, Placebo-controlled Study of Single Ascending Doses of NNC4004-0002 in Adults With Asymptomatic Hyperuricemia
Key Details
Gender
All
Age Range
35 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-11-13
Completion Date
2026-06-01
Last Updated
2025-09-24
Healthy Volunteers
Yes
Conditions
Interventions
NNC4004-0002
NNC4004-0002 will be given as a single ascending dose via subcutaneous route.
Placebo
Placebo matched to NNC4004-0002 will be given via subcutaneous route.
Locations (2)
PAREXEL Glendale/LA EPCU
Glendale, California, United States
PAREXEL Intl - EPCU-Baltimore
Baltimore, Maryland, United States