Healthy VolunteersPhase 1NCT06859073
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
A Phase 1 study testing NNC4004-0002 in people with Healthy Volunteers and Hyperuricemia, run by Novo Nordisk A/S at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Hyperuricemia
- What is being tested?
- NNC4004-0002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Nov 2024to 16 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females 35 to 75 years of age at the time of signing the informed consent form (ICF).
- Considered to be generally healthy based on medical history, physical examination, and the re-sults of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Body mass index (BMI) 20 to 35 kilogram per meter square (kg/m2) (both inclusive) at screening.
- Serum uric acid levels greater than or equal to (≥) 6.8 miligram per decileter (mg/dL) to less than or equal (≤) 12 mg/dL on 2 consecutive screening samples (the first at the screening visit [V1], and the second taken at V2 [day -1]; samples at least 7 days apart).
Who cannot join
- Female who is pregnant, breastfeeding, or intends to become pregnant or is of childbearing po-tential and not using an adequate contraceptive method.
- Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
- Present or prior history of gout, or present or prior use of serum Uric acid (sUA) lowering medication.
- Serious cardiovascular or hepatic disease, current or past malignancies, or chronic debilitating neurologic, gastrointestinal, or inflammatory diseases.
- History or current diagnosis of chronic history kidney disease.
- Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) values greater than (>) 2 multiply by (×) upper limit normal (ULN) or total bilirubin >1.5× ULN.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PAREXEL Intl - EPCU-Baltimore
Baltimore, Maryland, 21225
PAREXEL Glendale/LA EPCU
Glendale, California, 91206
About this study
Official title: A Phase 1, Double-blinded, Placebo-controlled Study of Single Ascending Doses of NNC4004-0002 in Adults 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 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.
- Conditions
- Healthy Volunteers, Hyperuricemia
- Being tested
- NNC4004-0002, Placebo
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC4004-0002Drug
NNC4004-0002 will be given as a single ascending dose via subcutaneous route.
PlaceboDrug
Placebo matched to NNC4004-0002 will be given via subcutaneous route.
| Study group | Role | What they receive |
|---|---|---|
| NNC4004-0002 | Experimental | Participants will receive a single dose of NNC4004-0002 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts. Receives: Drug: NNC4004-0002 |
| Placebo | Placebo comparator | Participants in each cohort will receive placebo matched to NNC4004-0002 injected subcutaneously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent adverse event (TEAEs)
Count
Measured: From dosing (day 1) until end of study (approximately 28 weeks)
Secondary outcomes (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
microgram•hour/mililiter (μg•h/mL)
Measured: From dosing (day 1) to 72 hours postdose
Cmax: The maximum concentration of NNC4004-0002 in plasma
microgram/mililiter
Measured: From dosing (day 1) to 72 hours postdose
tmax: The time from dose administration to the maximum plasma concentration of NNC4004-0002
Hours
Measured: From dosing (day 1) to 72 hours postdose
Renal clearance
Liter/hour (L/h)
Measured: From time of dose to 72 hours postdose
Changes in serum Uric Acid (sUA) over time
miligram/deciliter
Measured: From baseline through the end of the study (approximately 28 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start13 Nov 2024
- Primary completion19 Jan 2027 (estimated)
- Study completion16 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859073
- Sponsor's protocol ID
- NN4004-8071
- Other IDs
- U1111-1317-9961
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blinded, Placebo-controlled Study of Single Ascending Doses of NNC4004-0002 in Adults With Asymptomatic Hyperuricemia
- ClinicalTrials.gov ID
- NCT06859073
- Acronym / sponsor ID
- NN4004-8071
- Conditions
- Healthy Volunteers, Hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 19 Jan 2027 (estimated)
- Study completion
- 16 Feb 2027 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC4004-0002 | Experimental | Drug: NNC4004-0002Participants will receive a single dose of NNC4004-0002 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in each cohort will receive placebo matched to NNC4004-0002 injected subcutaneously. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females 35 to 75 years of age at the time of signing the informed consent form (ICF).
- Considered to be generally healthy based on medical history, physical examination, and the re-sults of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Body mass index (BMI) 20 to 35 kilogram per meter square (kg/m2) (both inclusive) at screening.
- Serum uric acid levels greater than or equal to (≥) 6.8 miligram per decileter (mg/dL) to less than or equal (≤) 12 mg/dL on 2 consecutive screening samples (the first at the screening visit [V1], and the second taken at V2 [day -1]; samples at least 7 days apart).
Key exclusion criteria (6 listed)
- Female who is pregnant, breastfeeding, or intends to become pregnant or is of childbearing po-tential and not using an adequate contraceptive method.
- Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
- Present or prior history of gout, or present or prior use of serum Uric acid (sUA) lowering medication.
- Serious cardiovascular or hepatic disease, current or past malignancies, or chronic debilitating neurologic, gastrointestinal, or inflammatory diseases.
- History or current diagnosis of chronic history kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC4004-0002NNC4004-0002 will be given as a single ascending dose via subcutaneous route. | Drug | NNC4004-0002 |
| PlaceboPlacebo matched to NNC4004-0002 will be given via subcutaneous route. | Drug | Placebo |
Primary outcome
Number of Treatment-emergent adverse event (TEAEs)
Time frame: From dosing (day 1) until end of study (approximately 28 weeks)
Count
5 secondary outcomes
AUC(0-72): The area under the NNC4004-0002 plasma concentration-time curve from time zero to the 72 hours after a single dose
Time frame: From dosing (day 1) to 72 hours postdose
Cmax: The maximum concentration of NNC4004-0002 in plasma
Time frame: From dosing (day 1) to 72 hours postdose
tmax: The time from dose administration to the maximum plasma concentration of NNC4004-0002
Time frame: From dosing (day 1) to 72 hours postdose
Renal clearance
Time frame: From time of dose to 72 hours postdose
Changes in serum Uric Acid (sUA) over time
Time frame: From baseline through the end of the study (approximately 28 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC4004-0002 in people with Healthy Volunteers and Hyperuricemia, run by Novo Nordisk A/S at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-emergent adverse event (TEAEs) (time frame: From dosing (day 1) until end of study (approximately 28 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.