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

NCT ID NCT06208215

Disease control Sponsor: Rezolute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 56 people

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

Started

Jan 2024

Expected to finish

Nov 2027

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

3 months to 45 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: At screening, aged ≥ 3 months and ≤ 45 years old. An established clinical diagnosis of congenital HI (hyperinsulinism), with or without identification of a known monogenic variant by genetic testing. Participant has failed to achieve adequate glycemic control with appropriate and reasonable trials of locally accepted and available Standard of Care (SOC) medical therapies (e.g., diazoxide and somatostatin analogs (SSAs)) per the judgment of the investigator. Experiencing ≥ 3 hypoglycemia events per week by screening Self-Monitoring Blood Glucose (SMBG) and average daily percent time with hypoglycemia of ≥ 8% of the monitored screening Continuous Glucose Monitor (CGM) time. Exclusion Criteria: Alanine aminotransaminase (ALT), aspartate aminotransaminase (AST), total bilirubin (TB), alkaline phosphatase (ALP), and gamma-glutamyl transferase (GGT) ≥ 1.5 × the upper limit of normal for the age-specific reference range, regardless of assessed significance. Body mass index (BMI) ≥ 35 kg/m2 for participants aged 18 years and above, or BMI ≥ 99% (percentile) per Centers for Disease Control and Prevention growth charts for participants \> 12 and \< 18 years of age (no BMI exclusion for participants ≤ 12 years of age). A known clinical diagnosis of diabetes or pre-diabetes, or a history of insulin dependency within 3 months of screening. Average daily percent time with hyperglycemia ≥ 5% of the monitored screening continuous glucose monitoring (CGM) time. Known allergy or sensitivity to RZ358 or any component of the drug.

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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

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