Phase 2 study of HM15136 in Subjects with Congenital Hyperinsulinism
Research type
Research Study
Full title
A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
IRAS ID
300183
Contact name
Indraneel Banerjee
Contact email
Sponsor organisation
Hanmi Pharm. Co., Ltd.
Eudract number
2021-000508-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 10 days
Research summary
The purpose of this study is to find out about the safety and tolerability of the study drug (HM15136) and to determine if it is effective for the treatment of Congenital Hyperinsulinism (CHI). HM15136 is an experimental drug which is not approved by Health Authorities including the UK MHRA (The Medicines and Healthcare Products Regulatory Agency) for the treatment of CHI.
This is a Phase II “open-label” study. Phase II means that the study drug is being tested for effectiveness and to see what type of side effects participants have. Open Label means that the patient and the study doctor will know the dose of study drug received. The dose level assigned will depend on when patients enter the study.
HM15136 is an injectable drug that has been designed to act like glucagon, a hormone produced by the pancreas that helps the body maintain normal blood sugar levels. The study drug will be injected, once a week, by a short needle into the soft tissue under the skin in the abdomen.
The study includes male and female participants aged ≥2 years with CHI, who fulfil all the inclusion criteria for the study.
Approximately 16 people will take part in this study at a number of different locations in the USA, the UK and Germany. The study has 5 parts, including Screening, Run-in, Baseline, Treatment and Follow-up. The Baseline and Treatment study parts include 2 inpatient periods (5 days and 9 days), the remaining visits will be conducted as out-patient visits.
Patients will be given a glucose meter, continuous glucose monitoring system and an electronic diary to use during the study and will be asked about their lifestyle and activity. Study procedures will include blood and urine samples.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0156
Date of REC Opinion
9 Aug 2021
REC opinion
Further Information Favourable Opinion