Shot of hope: new drug may free teens with PKU from strict diet

NCT ID NCT05270837

First seen Oct 31, 2025 · Last updated May 08, 2026 · Updated 30 times

Summary

This study tests a drug called pegvaliase, given as a shot under the skin, in teenagers aged 12-17 with phenylketonuria (PKU) who have trouble keeping their blood Phe levels under control with diet alone. About 55 teens will be randomly assigned to either get the drug or stick with their usual diet-only care. The goal is to see if the drug safely lowers blood Phe levels and helps teens eat more protein.

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Contacts and locations

Locations

  • Ann and Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Charité - Universitätsmedizin Berlin

    Berlin, Germany

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • IU Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth)

    Houston, Texas, 77030, United States

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Universitat Mainz

    Mainz, Germany

  • University of Kentucky College of Medicine

    Lexington, Kentucky, 40506, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15224, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132, United States

  • University of Virginia School of Medicine

    Charlottesville, Virginia, 22903, United States

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

Conditions

Explore the condition pages connected to this study.