NCT06859073

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

StatusActive, Not Recruiting

PhasePhase 1

SponsorNovo Nordisk A/S

Primary completionJan 19, 2027 (estimated)

At risk: Primary completion moved at least 7 months later.

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

Notable Oct 21, 2026 Primary completion pushed from Jun 1, 2026 to Jan 19, 2027 Show 6 more changesShow less
- Eligibility criteria expanded, about 10 words
- Enrollment closed, study ongoing
- Final enrollment: 50 participants (planned 60)
- Study completion pushed from Jun 1, 2026 to Feb 16, 2027
- Secondary endpoints: details revised at 4 of 5 entries
- Site details revised at 2 of 2 sites
Minor Sep 23, 2025 Study sites: 1 to 2
- Primary completion date: May 19, 2026 to Jun 1, 2026
- Study completion date: Jul 7, 2026 to Jun 1, 2026
v4
Minor Mar 28, 2025 Study completion date: May 19, 2026 to Jul 7, 2026v3
Minor Mar 5, 2025 Study site revisedv2
Feb 27, 2025 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Number of Treatment-emergent adverse event (TEAEs)

Timeframe: From dosing (day 1) until end of study (approximately 28 weeks)

Secondary (5)

AUC(0-72): The area under the NNC4004-0002 plasma concentration-time curve from time zero to the 72 hours after a single dose

Cmax: The maximum concentration of NNC4004-0002 in plasma

tmax: The time from dose administration to the maximum plasma concentration of NNC4004-0002

Renal clearance

Changes in serum Uric Acid (sUA) over time

Arms and interventions

NNC4004-0002Experimental

Participants will receive a single dose of NNC4004-0002 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.

PlaceboPlacebo comparator

Participants in each cohort will receive placebo matched to NNC4004-0002 injected subcutaneously.

Drugs: NNC4004-0002, Placebo

Sites

2 sites in 1 country

About this trial

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.

Trial details

Enrollment: 50 participants (actual)
Started: Nov 13, 2024
Study completion: Feb 16, 2027 (estimated)
Eligibility: 35 to 75, all sexes, healthy volunteers accepted
Design: Interventional, randomized, double blind, treatment
Oversight: No data monitoring committee, FDA-regulated drug
Conditions: Hyperuricemia, Healthy Volunteers
Official title: A Phase 1, Double-blinded, Placebo-controlled Study of Single Ascending Doses of NNC4004-0002 in Adults With Asymptomatic Hyperuricemia
First posted: Mar 5, 2025
Registry updated: Oct 26, 2026
Last verified: Oct 2026

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