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RecruitingPhase 2

Study of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1 (PH1)

YolTech Therapeutics Co., Ltd · NCT07587021

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
36
US sites recruiting
2
Study start
September 16, 2026
Record last updated
October 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This study will be conducted to evaluate the efficacy and safety of YOLT-203 in children and adults with Primary Hyperoxaluria Type 1.

After the initial randomized, 6-month double-blind, placebo-controlled period, participants who were initially assigned to placebo will receive a single-dose of YOLT-203 treatment whereas participants in the YOLT-203 group will receive a single-dose of placebo infusion.

For patients interested in additional information on how to participate, please follow this link: https://mytomorro.ws/ph1trial.

Being studied: YOLT-203; Placebo

Conditions: Primary Hyperoxaluria Type 1; PH1

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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).

Recruiting US locations

  • University of Alabama at Birmingham (UAB Hospital)

    Birmingham, AL 35249

    Site contact: Crystal Taylor · 205-934-3411 · crystalmtaylor@uabmc.edu

  • Childrens Hospital of Colorado

    Aurora, CO 80045

    Site contact: Kati Dugan · 720-777-8215 · Kati.dugan@childrenscolorado.org

Study contacts (from the official record)

  • Kim Marie Grabbe, MS, MBA · 217-851-5517 · Kim.Marie.Grabbe@yoltx.com
  • Claudia Rainolter · 412-227-1722 · claudia.rainolter@yoltx.com
Study of YOLT-203 in Children and Adults With Primary… (NCT07587021) | Bored Studies