In short
Currently, there is 1 ongoing clinical trial for Congenital Hyperinsulinaemic Hypoglycaemia, a rare condition where the body produces too much insulin, leading to dangerously low blood sugar levels. This trial is investigating a new injectable treatment called HM15136 in children aged 2 years and older. The study is being conducted in Germany and aims to evaluate the safety and effectiveness of this experimental medication over an 8-week treatment period.
Clinical trial locations
Study on the Safety and Effects of Efpegerglucagon in Children Aged 2 and Older with Congenital Hyperinsulinism
This clinical trial is investigating HM15136, an experimental treatment for children with Congenital Hyperinsulinism. The condition causes the body to produce excessive amounts of insulin, which leads to frequent episodes of low blood sugar that can be dangerous if not properly managed.
Main inclusion criteria:
- Children aged 2 years and older with confirmed Congenital Hyperinsulinism
- Experiencing at least 3 episodes of low blood sugar per week, despite receiving standard treatments
- Currently on stable treatment with medications such as diazoxide or somatostatin analogs, or not responding to standard medications
- Children aged 2 to 11 years must have been on stable treatment with diazoxide or octreotide for at least 1 month before joining
- Children aged 12 and older must have been on stable treatment with diazoxide or somatostatin analogs for at least 3 months
- HbA1c level (a measure of blood sugar control over time) below 7%
- Female participants of childbearing age must agree to use effective birth control during the study and for 60 days afterward
- Parents or guardians must provide informed consent for children participating in the study
Main exclusion criteria:
- Other serious health conditions that could interfere with the study
- Currently participating in another clinical trial
- Recent surgery or planned surgery during the study period
- Pregnancy or breastfeeding
- History of allergic reactions to similar medications
- Unable to follow study procedures or attend required visits
- History of drug or alcohol abuse
- Certain heart conditions or uncontrolled high blood pressure
- History of certain mental health disorders
Focus and goal of the trial: The study is designed to evaluate how safe HM15136 is for children with this condition and how well their bodies tolerate the treatment. Researchers will carefully monitor participants throughout the 8-week treatment period to check for any side effects and to understand how the medication is processed by the body. The trial will also examine whether the treatment helps reduce the frequency of low blood sugar events. This is an open-label study, meaning both researchers and participants know that HM15136 is being given. The medication is administered through injections under the skin using a pre-filled syringe. If no significant side effects occur during the initial 8-week period, participants may have the option to continue treatment in an extended phase.
Investigational drug: HM15136 is an experimental medication being tested specifically for Congenital Hyperinsulinism. At the molecular level, it works by helping to regulate insulin secretion, which can help maintain more stable blood sugar levels. The medication is given by injection and is classified as a treatment for metabolic disorders. It is important to note that HM15136 is still in the research phase and is not yet available for general medical use outside of clinical trials.
Summary
Currently, only one clinical trial is actively recruiting patients with Congenital Hyperinsulinaemic Hypoglycaemia. This trial is located in Germany and focuses exclusively on children aged 2 years and older who continue to experience frequent low blood sugar episodes despite standard treatment. The trial is investigating HM15136, a new injectable medication designed to help regulate insulin levels and reduce hypoglycemic events. The study emphasizes safety monitoring and understanding how the body processes this experimental treatment over an 8-week period, with the possibility of extended treatment for those who tolerate it well. This represents an important research effort for a rare condition that can have serious consequences if not properly managed, particularly in young children.
