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Anti-(Insulin Receptor) Human Monoclonal Antibody

A groundbreaking clinical trial is underway to assess the efficacy and safety of a new drug called RZ358, an anti-insulin receptor human monoclonal antibody, for treating congenital hyperinsulinism. This Phase 3 study aims to help patients who have not achieved adequate glycemic control with standard treatments. The trial focuses on reducing hypoglycemia events and improving overall blood glucose management in patients with this rare genetic condition.

Table of Contents

What is RZ358?

RZ358 is a new medication being studied for the treatment of congenital hyperinsulinism. It is also known as anti-(insulin receptor) human monoclonal antibody. This means it’s a specially designed protein that targets and interacts with insulin receptors in the body.[1]

What is Congenital Hyperinsulinism?

Congenital hyperinsulinism is a rare genetic condition where the body produces too much insulin. This leads to frequent episodes of low blood sugar (hypoglycemia), which can be dangerous if not managed properly. The condition is present from birth (congenital) and can be challenging to treat with current medications.[1]

How RZ358 Works

RZ358 is designed to help manage blood sugar levels in people with congenital hyperinsulinism. It works by:

  • Attaching to insulin receptors in the body
  • Reducing the effect of excess insulin
  • Helping to prevent dangerous drops in blood sugar
This approach is different from other treatments that try to reduce insulin production.[1]

Clinical Trial Details

A Phase 3 clinical trial is currently underway to evaluate the effectiveness and safety of RZ358. Here are some key details:

  • The trial is randomized, double-blind, and placebo-controlled. This means participants are randomly assigned to receive either RZ358 or a placebo, and neither the participants nor the researchers know who is receiving which treatment.
  • The study will last 24 weeks, with some participants potentially continuing treatment for up to 2 years.
  • RZ358 is given as an intravenous infusion (through a vein) every 2 or 4 weeks.
  • Two different doses are being tested: 5 mg/kg and 10 mg/kg.
  • The main goal is to see if RZ358 can reduce the number of hypoglycemia events (low blood sugar episodes) compared to a placebo.
[1]

Eligibility Criteria

To participate in the trial, patients must meet certain criteria. Some key requirements include:

  • Age: 3 months to 45 years old
  • Diagnosed with congenital hyperinsulinism
  • Experiencing at least 3 hypoglycemia events per week
  • Not adequately controlled with current standard treatments
There are also several exclusion criteria, such as recent major surgery, pregnancy, or certain medical conditions.[1]

Potential Benefits

If successful, RZ358 could offer several benefits for patients with congenital hyperinsulinism:

  • Reduced frequency of hypoglycemia events
  • Improved blood sugar control
  • Better quality of life with less need for frequent blood sugar monitoring and emergency treatments
  • A new option for patients who don’t respond well to current treatments
[1]

Safety Considerations

As with any new medication, safety is a top priority in the RZ358 clinical trial. Researchers will be closely monitoring:

  • Side effects and adverse events
  • Changes in laboratory tests
  • Effects on the liver (through ultrasound scans)
  • Any signs of high blood sugar (hyperglycemia)
  • The body’s immune response to the medication
It’s important to note that RZ358 is still being studied and is not yet approved for general use. The clinical trial will help determine if it’s safe and effective for treating congenital hyperinsulinism.[1]

Aspect Details
Drug Name RZ358 (Anti-Insulin Receptor Human Monoclonal Antibody)
Condition Treated Congenital Hyperinsulinism
Trial Phase Phase 3
Study Design Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm
Primary Objective Assess glycemic efficacy by measuring hypoglycemia events over 24 weeks
Key Eligibility Criteria Age 3 months to 45 years, diagnosed with congenital HI, inadequate control with standard therapies
Treatment Arms 5 mg/kg RZ358, 10 mg/kg RZ358, Placebo (all with standard of care)
Administration Intravenous infusion
Study Duration 24-week pivotal period, followed by up to 2-year open-label extension
Follow-up Period 8 weeks post-treatment

FAQ

  • What is congenital hyperinsulinism? Congenital hyperinsulinism is a rare genetic condition where the body produces too much insulin, leading to frequent and severe episodes of low blood sugar (hypoglycemia). This can be dangerous, especially for infants and young children, and may cause developmental issues if not properly managed.
  • Who is eligible to participate in this clinical trial? The trial is open to patients aged 3 months to 45 years with a clinical diagnosis of congenital hyperinsulinism. Participants must have failed to achieve adequate blood sugar control with standard treatments and experience at least 3 hypoglycemia events per week or spend 8% or more of their time in a hypoglycemic state.
  • What is RZ358 and how does it work? RZ358 is an anti-insulin receptor human monoclonal antibody. It works by binding to insulin receptors, which may help regulate insulin's effects on blood sugar levels. This could potentially reduce the frequency and severity of hypoglycemia events in patients with congenital hyperinsulinism.
  • How is the clinical trial structured? The trial has a double-blind, placebo-controlled pivotal treatment period where participants receive either RZ358 or a placebo along with their standard of care treatment. This is followed by an open-label extension period where all participants can receive RZ358 for up to 2 years. After treatment ends, there is an 8-week follow-up period.
  • What are the main outcomes being measured in this trial? The primary outcome is the change in the average weekly number of hypoglycemia events after 24 weeks of treatment. Secondary outcomes include the change in daily time spent in hypoglycemia, safety and tolerability of RZ358, and its effects on potentially serious hypoglycemia events. The trial will also assess the drug's pharmacokinetics (how the body processes the drug) in different age groups and doses.

Ongoing Clinical Trials on Anti-(Insulin Receptor) Human Monoclonal Antibody

  • Study on Ersodetug for Patients with Uncontrolled Low Blood Sugar Due to Tumor-Related High Insulin Levels

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France The Netherlands

  • Study on RZ358 for Treating Congenital Hyperinsulinism in Patients

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Denmark France Germany Greece Spain

Glossary

  • Congenital Hyperinsulinism: A rare genetic disorder where the pancreas produces too much insulin, leading to frequent and severe low blood sugar episodes.
  • Hypoglycemia: A condition where blood sugar levels are lower than normal, typically below 70 mg/dL or 3.9 mmol/L.
  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to specific targets in the body, used in this case to target insulin receptors.
  • Standard of Care (SOC): The currently accepted methods of treatment for a specific condition, such as diazoxide or somatostatin analogs for congenital hyperinsulinism.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Double-Blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment or placebo.
  • Placebo: An inactive substance that looks like the drug being tested but has no therapeutic effect.
  • Open-Label Extension (OLE): A phase of a clinical trial where all participants receive the active treatment, usually following the main study period.
  • Continuous Glucose Monitoring (CGM): A method to track glucose levels continuously throughout the day and night using a small sensor inserted under the skin.
  • Self-Monitored Blood Glucose (SMBG): The practice of testing one's own blood glucose levels, typically using a portable blood glucose meter.

References

  1. http://clinicaltrials.eu/trial/study-on-rz358-for-treating-congenital-hyperinsulinism-in-patients/