NNC4004-0002 for High Uric Acid

Recruiting at 2 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must not be taking: Uric acid medications

Disqualifiers: Gout, Cardiovascular, Hepatic, others

Compensation: Varies

Number of Visits: 14

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new drug, NNC4004-0002, to determine if it can safely reduce high uric acid levels with a single injection. High uric acid can lead to conditions like gout, so the study targets adults with elevated levels who aren't yet showing symptoms. Participants will randomly receive either the experimental drug or a placebo (a saltwater solution). Those with serum uric acid levels between 6.8 and 12 mg/dL and no history of gout might qualify for this 7-month study. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used serum uric acid lowering medication before.

Is there any evidence suggesting that NNC4004-0002 is likely to be safe for humans?

Research shows that NNC4004-0002 is undergoing its first human testing to assess safety and tolerance. As this is an early trial, information about side effects remains limited. The study administers a single dose to healthy adults with high uric acid levels to observe their body's response.

As a Phase 1 trial, this marks the initial step in human testing. Safety is the primary focus, and researchers closely monitor for any reactions. Although no existing data on its safety in humans is available, the trial aims to gather this crucial information. Participants will attend several clinic visits to ensure their well-being throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about NNC4004-0002 for high uric acid because it introduces a novel approach compared to traditional treatments like allopurinol and febuxostat. Unlike these standard medications that reduce uric acid production or enhance its excretion, NNC4004-0002 is administered via a single subcutaneous injection, which could offer more convenience and potentially improve patient adherence. Additionally, the treatment is being tested in ascending single-dose cohorts, which may help determine the precise dosing needed for optimal effectiveness with minimal side effects.

What evidence suggests that NNC4004-0002 might be an effective treatment for high uric acid?

Researchers are investigating NNC4004-0002 to determine if it can lower high uric acid levels in the blood. This trial will include participants receiving a single dose of NNC4004-0002, while others will receive a placebo. NNC4004-0002 might work by affecting uric acid production in the body. Although it hasn't been tested in people yet, its mechanism suggests it could help reduce uric acid levels. This is important for individuals with conditions like gout, where high uric acid can cause painful joint problems. Early studies focus on ensuring NNC4004-0002 is safe and well-tolerated by the body. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This study is for adults with asymptomatic hyperuricemia, which means they have high uric acid levels but no symptoms. Participants should be generally healthy and willing to receive injections under their skin. They'll need to commit to a 7-month study period with around 14 clinic visits, including a 4-night stay.

Inclusion Criteria

Considered to be generally healthy based on medical history, physical examination, and the results 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) at screening

Serum uric acid levels ≥ 6.8 miligram per decileter (mg/dL) to ≤ 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)

Exclusion Criteria

Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) values > 2× upper limit normal (ULN) or total bilirubin >1.5× ULN

I do not have serious heart, liver, past cancers, or chronic debilitating diseases.

I have or had chronic kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of NNC4004-0002 or placebo injected subcutaneously

1 day

1 visit (in-person), 4-night in-house stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Approximately 13 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NNC4004-0002

Trial Overview

The trial is testing NNC4004-0002, an investigational drug not yet approved by the FDA. It's given as an injection and compared against saline (placebo) to see if it can safely lower serum uric acid after just one dose in participants.

How Is the Trial Designed?

Group I: NNC4004-0002 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Published Research Related to This Trial

In a study of 230 gout patients, 73% successfully achieved their target serum urate levels with urate lowering therapy, indicating that the treatment is generally effective.

The primary reason for the 27% of patients who did not reach their target was non-adherence to the treatment regimen, highlighting the importance of patient compliance in managing gout effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving serum urate targets in gout: an audit in a gout-oriented rheumatology practice. Corbett, EJM., Pentony, P., McGill, NW.[2018]

In a study of 102 gout patients, 78% achieved the recommended serum uric acid target of <360 μmol/L, while 65% met the stricter target of <300 μmol/L, indicating effective management of gout with current therapies.

The majority of patients (84%) were treated with allopurinol, suggesting that adherence to uric acid-lowering therapy is high, and a treat-to-target approach may enhance patient outcomes in gout management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to uric acid treatment guidelines in a rheumatology clinic. Conway, R., Coughlan, RJ., Carey, JJ.[2021]

In a study of 292,270 individuals with gout, initiating urate-lowering therapy (ULT) was linked to a higher risk of hospitalizations for gout flares within the first 6 months (adjusted Hazard Ratio of 4.54), but this risk decreased significantly after 12 months.

Achieving a serum urate level of less than 360 micromol/l within the first year of ULT initiation was associated with a 43% reduction in the risk of hospitalizations, highlighting the importance of reaching treatment targets for long-term management of gout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treat-to-target urate-lowering therapy and hospitalizations for gout: results from a nationwide cohort study in England. Russell, MD., Roddy, E., Rutherford, AI., et al.[2023]

In a 12-week study of Chinese patients with gout receiving benzbromarone, 60.5% of those classified as renal underexcretors achieved the target serum urate level (<360 μmol/L), compared to only 39.0% of patients in the unclassified group, indicating that hyperuricemia classification can improve treatment outcomes.

Patients in the underexcretion group also showed lower blood glucose and cholesterol levels without a significant difference in the frequency of gout attacks, suggesting that targeting treatment based on hyperuricemia classification may enhance overall health outcomes for gout patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Clinical Typing on Serum Urate Targets of Benzbromarone in Chinese Gout Patients: A Prospective Cohort Study. Xue, X., Yuan, X., Han, L., et al.[2022]

In a study of 90 patients with gout, increasing the dose of allopurinol above the standard recommendations resulted in a significant reduction in serum urate levels, with about 89% of patients achieving the target level of <0.36 mmoles/liter after 12 months.

The study found that higher doses of allopurinol did not lead to increased toxicity, even in patients with renal impairment, indicating that dose escalation can be a safe and effective strategy for managing gout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using allopurinol above the dose based on creatinine clearance is effective and safe in patients with chronic gout, including those with renal impairment. Stamp, LK., O'Donnell, JL., Zhang, M., et al.[2013]

Citations

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withpower.com

withpower.com/trial/phase-1-hyperuricemia-10-2024-ac50d

NNC4004-0002 for High Uric Acid

Research shows that increasing the dose of allopurinol, a drug used to lower uric acid, is effective and safe for patients with gout, even those with kidney ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06859073

NCT06859073 | A Research Study to Evaluate the Safety ...

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.

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novonordisk-trials.com

novonordisk-trials.com/trials-conditions/all-trials-v2/NN4004-8071.html

A Research Study to Evaluate the Safety of NNC4004 ...

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.

4.

tipranks.com

tipranks.com/news/company-announcements/novo-nordisks-new-study-on-nnc4004-0002-a-potential-game-changer-in-hyperuricemia-treatment

Novo Nordisk's New Study on NNC4004-0002: A Potential ...

The study aims to evaluate the safety and tolerability of NNC4004-0002, an investigational drug, in reducing serum uric acid levels in adults ...

5.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0004938

Hyperuricemia (DBCOND0004938)

A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia. NNC4004-0002. treatment, 1, recruiting.

6.

withpower.com

withpower.com/t/duzallo

Duzallo: Everything you need to know | Power

NNC4004-0002 for High Uric Acid. 35 - 75. All Sexes. Baltimore, MD. "This trial ... This trial will test the effects and safety of AR882 on lowering serum uric ...