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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Hyperuricemia
• Intervention / Treatment: Drug: NNC4004-0002; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Not yet recruiting
      • PAREXEL Glendale/LA EPCU
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Recruiting
      • PAREXEL Intl - EPCU-Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC4004-0002; Participants will receive a single dose of NNC4004-0002 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.	Drug: NNC4004-0002; NNC4004-0002 will be given as a single ascending dose via subcutaneous route.
Placebo Comparator: Placebo; Participants in each cohort will receive placebo matched to NNC4004-0002 injected subcutaneously.	Drug: Placebo; Placebo matched to NNC4004-0002 will be given via subcutaneous route.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment-emergent adverse event (TEAEs)	Count	From dosing (day 1) until end of study (approximately 28 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From dosing (day 1) to 72 hours postdose
Cmax: The maximum concentration of NNC4004-0002 in plasma	microgram/mililiter	From dosing (day 1) to 72 hours postdose
tmax: The time from dose administration to the maximum plasma concentration of NNC4004-0002	Hours	From dosing (day 1) to 72 hours postdose
Renal clearance	Liter/hour (L/h)	From time of dose to 72 hours postdose
Changes in serum Uric Acid (sUA) over time	miligram/deciliter	From baseline through the end of the study (approximately 28 weeks)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperuricemia
• Other Study ID Numbers: NN4004-8071; U1111-1317-9961 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No