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

Part of paid clinical trials in Glendale, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT06859073
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • NNC4004-0002 — DRUG
    NNC4004-0002 will be given as a single ascending dose via subcutaneous route.
  • Placebo — DRUG
    Placebo matched to NNC4004-0002 will be given via subcutaneous route.

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
Sep 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC4004-0002
    Participants will receive a single dose of NNC4004-0002 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.
  • Placebo Comparator: Placebo
    Participants in each cohort will receive placebo matched to NNC4004-0002 injected subcutaneously.

Primary Outcome Measure

Number of Treatment-emergent adverse event (TEAEs) [ Time Frame: From dosing (day 1) until end of study (approximately 28 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
PAREXEL Glendale/LA EPCUGlendaleCalifornia91206-
PAREXEL Intl - EPCU-BaltimoreBaltimoreMaryland21225-

Find similar trials in Glendale, CA

By research site
PAREXEL Glendale/LA EPCU· Glendale, CAPAREXEL Intl - EPCU-Baltimore· Baltimore, MD

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