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NCT06859073 · ClinicalTrials.gov registry record · Phase 1
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
A Phase 1 study of Healthy Volunteers and Hyperuricemia, sponsored by Novo Nordisk A/S.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT06859073: Recruiting Phase 1 study of Healthy Volunteers and Hyperuricemia, sponsored by Novo Nordisk A/S.
NCT06859073 is a Phase 1 study of Healthy Volunteers and Hyperuricemia that is actively recruiting participants, run by Novo Nordisk A/S. The registered enrollment target is 60 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06859073, a Phase 1 study of Healthy Volunteers and Hyperuricemia, is actively recruiting participants, sponsored by Novo Nordisk A/S.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Count
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NNC4004-0002
Study Locations (2)
California
- PAREXEL Glendale/LA EPCU - Glendale
Maryland
- PAREXEL Intl - EPCU-Baltimore - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-11-13 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 1 |
What NCT06859073 shows while recruiting
NCT06859073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06859073 reports a single indexed study location in California, Maryland.
Frequently Asked Questions
What is clinical trial NCT06859073 about?
NCT06859073 is a clinical study titled "A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia". 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 NNC...
What is the current status of trial NCT06859073?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-11-13. Estimated completion is 2026-06-01.
What conditions does trial NCT06859073 study?
This clinical trial studies the following conditions: Healthy Volunteers, Hyperuricemia.
What interventions are being tested in trial NCT06859073?
The interventions under investigation include: Placebo (DRUG), NNC4004-0002 (DRUG).
Who is sponsoring clinical trial NCT06859073?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06859073 being conducted?
This trial has 2 study locations across California, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06859073's enrollment target sits among peer trials
60 109th of 283 higher than 163 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
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