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Promising new treatment for rare sugar disorder moves to final testing phase

NCT ID NCT06208215

Ongoing Disease control Sponsor: Rezolute Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an investigational drug called RZ358 for people with congenital hyperinsulinism, a rare condition causing dangerously low blood sugar. The trial involves 56 participants aged 3 months to 45 years who still have low blood sugar despite standard treatments. Over 24 weeks, half will receive RZ358 plus standard care, and half will receive a placebo plus standard care, to see if the drug reduces low blood sugar events safely.

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Conditions

The condition(s) this trial relates to.

Congenital Hyperinsulinism Digestive System Diseases familial hyperinsulinism glucose metabolism disease hyperinsulinism hypoglycemia metabolic disease pancreas disorder

As listed by the trial registrant

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

CONGENITAL HYPERINSULINISM

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104, United States

  • Rezolute Investigative Site, Al Rayyan, Qatar

    Al Rayyan, Qatar

  • Rezolute Investigative Site, Ankara, Turkey

    Ankara, 06800, Turkey (Türkiye)

  • Rezolute Investigative Site, Athens, Greece

    Athens, 115 27, Greece

  • Rezolute Investigative Site, Barcelona, Spain

    Barcelona, 08035, Spain

  • Rezolute Investigative Site, Berlin, Germany

    Berlin, 13353, Germany

  • Rezolute Investigative Site, Bron, France

    Bron, 69677, France

  • Rezolute Investigative Site, Dusseldorf, Germany

    Düsseldorf, 40225, Germany

  • Rezolute Investigative Site, Hà Nội, Vietnam

    Hà Nội, 100000, Vietnam

  • Rezolute Investigative Site, London, United Kingdom

    London, WC1N 3JH, United Kingdom

  • Rezolute Investigative Site, Manchester, United Kingdom

    Manchester, M13 9WL, United Kingdom

  • Rezolute Investigative Site, Odense, Denmark

    Odense, 5000, Denmark

  • Rezolute Investigative Site, Paris, France

    Paris, 75015, France

  • Rezolute Investigative Site, Seeb, Oman

    Seeb, 123, Oman

  • Rezolute Investigative Site, Sevilla, Spain

    Seville, 41013, Spain

  • Rezolute Investigative Site, Tbilisi, Georgia

    Tbilisi, 0159, Georgia

  • Rezolute Investigative Site, Varna, Bulgaria

    Varna, 9010, Bulgaria

More trials for these conditions

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