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New hope for rare kidney disease: experimental drug YOLT-203 enters phase 2 trial

NCT ID NCT07587021

Disease control Sponsor: YolTech Therapeutics Co., Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 09, 2026 · Updated 4 times

Summary

This study tests an experimental drug, YOLT-203, in 36 children and adults with primary hyperoxaluria type 1 (PH1), a rare genetic condition that causes painful kidney stones and kidney damage. The goal is to see if a single dose can safely lower oxalate levels in urine and blood over 6 months. Half the participants will get the drug first, while the other half will receive a placebo; after 6 months, everyone will receive the active drug.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

6 years and older

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 * You are 6 years old or older. * You have been diagnosed with PH1 (primary hyperoxaluria type 1) through genetic testing. * Urine tests show that your oxalate levels are not within certain limits (based on at least two 24-hour urine collections). * If you take vitamin B6, your dose has been stable for at least 3 months, and you are willing to keep it the same during the study. * You (and/or your parent or legal guardian, if you are under 18) understand the study and agree to follow all study requirements, including signing a consent form. Exclusion Criteria * You have signs that oxalate has affected parts of your body outside the kidneys. * Your liver blood tests are not within certain limits. * You have certain abnormal blood clotting results (unless controlled with medication like warfarin). * You have HIV, or active or chronic hepatitis C. * You are pregnant, planning to become pregnant, or breastfeeding. * You are not willing to use birth control during the study and for 6 months after (if applicable). * You are unable to limit alcohol intake to no more than about 2 drinks per day. * You have had alcohol or drug abuse in the past year. * You are unable to follow standard treatments for PH1 (such as drinking plenty of fluids, taking prescribed medications like potassium citrate, or following dietary advice).

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Conditions

The condition(s) this trial relates to.

Hyperoxaluria Kidney Calculi primary hyperoxaluria primary hyperoxaluria type 1

As listed by the trial registrant

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

PH1 Primary hyperoxaluria type 1

How to take part

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

  1. The places running it

    4 sites. 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

  • Childrens Hospital of Colorado

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Alabama at Birmingham (UAB Hospital)

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • University of Pennsylvania Health System (UPHS) - Penn Medicine

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Washington University/Barnes Jewish Hospital

    NOT_YET_RECRUITING

    St Louis, Missouri, 63108, United States

More trials for these conditions

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