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New mRNA shot aims to tame stubborn gout

NCT ID NCT07587684

Disease control Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This early-stage trial tests a new mRNA medicine called IN026 in 16 adults with refractory gout — gout that doesn't get better with standard treatments. The drug is given as an IV infusion and is designed to lower uric acid levels and shrink uric acid crystals (tophi). The main goal is to check safety, but researchers will also see if it helps control the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IN026 (an mRNA therapy given as an IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-control gout that doesn't respond to standard therapies.
What could go wrong
This is a very early, small Phase 1 trial with only 16 participants, so it's mainly checking safety. It may not lower uric acid effectively or could cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Can voluntarily sign the informed consent form (ICF) and comply with ICF and study protocol requirements. 2. Male or female, 18-75 years old (inclusive) at screening. 3. Meet 2015 ACR/EULAR gout classification criteria, in the intercritical phase of gout or acute flare resolved ≥2 weeks at screening. 4. Serum uric acid ≥420 μmol/L (7 mg/dl) at screening. 5. Meet the definition of refractory gout (poor uric acid control accompanied by severe gout symptoms) Exclusion Criteria: 1. Gout secondary to radiotherapy/chemotherapy, lead poisoning, organ transplantation, tumor, etc. at screening/baseline. 2. Rheumatoid arthritis, infectious/septic arthritis, or other acute inflammatory arthritis at screening/baseline. 3. Glucose-6-phosphate dehydrogenase (G6PD) deficiency history, or G6PD level below normal lower limit. 4. Positive HBsAg; HCV antibody positive is excluded except those with sustained HCV-RNA negativity after standard treatment; HIV antibody positive; active syphilis. 5. Presence of chronic liver diseases including active hepatitis, cirrhosis and alcoholic liver disease. 6. Participants with a history of any of the following: serious cardiovascular diseases within 6 months prior to screening; or serious diseases of the digestive, respiratory, urinary, musculoskeletal, neuropsychiatric, hematological, or immune systems within 3 months prior to screening. 7. Prolonged QTcF at screening. 8. Uncontrolled or untreated hypertension at screening. 9. Participants who have received medications that may affect endpoint assessment, such as other urate-lowering therapies, mRNA-LNP vaccine, PEGylated drugs and uricase agents. 10. History of severe allergy, or known allergy to IN026 or its components. 11. Participation in other clinical trials within 30 days prior to screening. 12. Participants with poor compliance, or those deemed otherwise unsuitable for this study by the investigator.

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Conditions

The condition(s) this trial relates to.

gout Hyperuricemia metabolic disease rheumatic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Refractory gout

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.