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    Summary
    EudraCT Number:2021-000508-39
    Sponsor's Protocol Code Number:HM-GCG-201
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-31
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-000508-39
    A.3Full title of the trial
    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) (ACHIEVE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to Evaluate the Safety, the Tolerability, the Pharmacokinetics and the Efficacy of HM15136 administered in pediatric Patients with Congenital Hyperinsulinism (CHI)
    A.4.1Sponsor's protocol code numberHM-GCG-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04732416
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHanmi Pharm. Co., Ltd.
    B.1.3.4CountryKorea, Republic of
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHanmi Pharm. Co., Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHanmi Pharm. Co., Ltd.
    B.5.2Functional name of contact pointSeungjae Baek
    B.5.3 Address:
    B.5.3.1Street Address14, Wiryeseong-daero, Songpa-gu,
    B.5.3.2Town/ citySeoul
    B.5.3.3Post code05545
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82-2-410-9039
    B.5.5Fax number+82-2-410-9278
    B.5.6E-mailseungjae.baek@hanmi.co.kr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2022
    D.3 Description of the IMP
    D.3.2Product code HM15136
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHM15136
    D.3.9.2Current sponsor codeHM15136
    D.3.9.3Other descriptive nameGlucagon analogue linked to a human immunoglobulin Fc fragment
    D.3.9.4EV Substance CodeSUB205324
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Congenital Hyperinsulinism (CHI)
    E.1.1.1Medical condition in easily understood language
    Congenital hyperinsulinism is a disorder associated with severe, persistent hypoglycemia, characterized by excessive and dysregulated insulin secretion by the pancreatic β-cells.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061211
    E.1.2Term Hyperinsulinism
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10083499
    E.1.2Term Congenital hyperinsulinemic hypoglycemia
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objectives:
    • to evaluate the safety and tolerability profile of HM15136
    • to evaluate the PK profile of HM15136
    E.2.2Secondary objectives of the trial
    Secondary Objective:
    • to evaluate the reduction of weekly hypoglycemia events by HM15136 (self-monitored blood glucose [SMBG])
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria at screening will be eligible to participate in the clinical study.
    Note: Subjects not eligible because of laboratory result(s) may have the laboratory test(s) (hematology, clinical chemistry including liver function tests, hemoglobin A1c [HbA1c], and electrocardiogram [ECG]) repeated once during the screening period at the discretion of the investigator to determine eligibility.
    Inclusion Criteria
    1. Cohort 1 (0.04 mg/kg): Male and female subjects aged ≥2 years (applicable to the US) and male and female subjects aged ≥12 years
    (applicable to Germany, UK, and Israel); Cohort 2 (0.06 mg/kg): Male and female subjects aged ≥2 years in all countries.
    2. Stable therapy with SoC medications with or without nutritional supplementation (nutritional supplementation includes enteral feeding such as gastric carbohydrates [administered orally, via nasogastric tube, or gastrostomy]) as described below:
    a) Subjects aged ≥12 years on stable therapy with diazoxide or somatostatin analog (ie, octreotide and lanreotide) for at least 3 months prior to screening Note: Subjects treated with octreotide infusion could be included after review by the investigator and medical monitor.
    b) Children aged 2 to 11 years on stable therapy with diazoxide or octreotide for at least 1 month prior to screening; if on lanreotide, stability should be for at least 3 months prior to screening
    c) Subjects receiving other medications such as sirolimus or nifedipine could be included after review by the investigator and medical monitor
    3. Subjects on long-acting somatostatin analog may be enrolled in the study if they have been on stable monthly (every 4 weeks) injections for at least 3 months before screening. Subjects would be required to synchronize their monthly somatostatin analog injection with the first and fifth injection of HM15136 (first dosing date = long-acting somatostatin injection date). Note: Lanreotide users not on every 4 weeks dosing regimen could be enrolled after discussion with the investigator and medical monitor
    4. HbA1c <7%
    5. Female subjects of childbearing potential must be nonpregnant and nonlactating. All females (regardless of age) of childbearing potential must have a negative urine/serum pregnancy test and must use highly effective methods of contraception throughout the duration of the study and until 60 days after final dose of HM15136 administration. Male subjects must agree to use condoms as a contraceptive measure throughout the duration of the study and until 60 days after final dose of HM15136 administration.
    6. Following receipt of oral and written information about the trial, the subject (children) (depending on local Institutional Review Board/Independent Ethics Committee requirements, or local regulatory requirements) must provide an assent and one or both parents (a) or guardians of the subject must provide signed informed consent before any trial-related activity is carried out. Adult subjects must provide signed informed consent. Adult subjects unable to provide informed consent and who require his/her legally authorized representative to provide informed consent will not be enrolled in the study.
    (a) If required by local regulations, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child
    E.4Principal exclusion criteria
    1.with type 1 / type 2 diabetes mellitus
    2. Other reasons for hypoglycemia, including but not limited to drug-induced hyperinsulinemic hypoglycemia, exogenous insulin-induced hypoglycemia, insulinoma, insulin resistance syndrome, nonislet cells tumor hypoglycemia, postgastric bypass, postfundoplication for gastroesophageal reflux, or dumping syndrome with postprandial hypoglycemia, or hypoglycemia due to other endocrine or inherited metabolic diseases
    3. Treatment of CHI with continuous intravenous glucose or glucagon infusion (requiring hospitalization of >1 W) within 1 M prior to screening (sc) (subj. treated with a transient intravenous glucose or glucagon infusion could be included after review by investigator & medical monitor)
    4. History of or current active disease of any clinically-significant surgical, medical, or psychiatric condition that, in judgment of investigator, might interfere with absorption, distribution/ metabolism of study drug, interpretation of study assessments/ pose an additional safety risk in administering study drug to subj.
    5. unable to tolerate adhesive tape or has any unresolved adverse skin reaction in area of CGMS sensor placement
    6. with current use of any drugs known to interfere with study drug, glucose metabolism/ study procedures (eg, use of systemic glucocorticoids [exclude. topical, intra-articular or ophthalmic application, nasal spray, or inhaled forms] for >10 consecutive days within 3 M prior to Sc / insulin)
    7. Consumption of alcohol in subj. <18 to 21 y. and heavy drinking in older adults
    8. Has participated in an interventional clinical trial (investigational or marketed product) within1 M of Sc or 5 half-lives of drug under investigation (whichever comes first)/ plans to participate in another interventional CT
    9. History of any major surgery within 6 M prior to sc (except for pancreatectomy)
    10. History of any serious adverse reaction or hypersensitivity to study drug components
    11. Anemia findings of hemoglobin <10 g/dL in clinical laboratory results at sc
    12. Abnormal clinical laboratory results at sc:
    a) History of renal disease/ abnormal kidney function tests at sc: estimated glomerular filtration rate <60 mL/min/1.73m2 as estimated using pediatric formula (Schwartz formula) for subj. <18 y. and chronic kidney disease epidemiology collaboration formula for subj. ≥18 y.
    b) Clinically significant thyroid function abnormality in opinion of investigator. If sc thyroid stimulating hormone is >1.5 x ULN or <0.4 mIU/L, reflex laboratory testing for T3 and free T4 will be performed
    c) Clinically significant abnormal hepatic function tests suggestive of hepatic impairment: alanine aminotransferase and/or aspartate aminotransferase >3 x ULN or total bilirubin >1.5 x ULN (unless due to Gilbert’s syndrome, total bilirubin >3.0 x ULN and direct bilirubin >1.5 x ULN).
    13. History of any clinically significant hepatic findings including gallstones (including incidental finding by ultrasonography or other imaging modalities)
    14. Hypertension or hypotension not on stable dose of supportive medication for at least 3 M prior to Scr
    15. Any clinically significant abnormality at sc identified on ECG that in opinion of investigator would affect subject’s ability to participate in trial or cardiac arrhythmia requiring medical or surgical treatment within 6 M prior to sc
    16. History of any active infection, other than mild viral illness within 30D prior to dosing as judged by investigator
    17. History of/ positive test for hepatitis B surface antigen, hepatitis C virus antibody, or HIV type 1 or type 2 antibody at sc
    18. Any anticipated procedures (eg surgery) that might interfere with compliance or completion of trial
    19. Presence of clinically significant physical examination, ECG, or clinical laboratory finding at sc that in opinion of investigator, may interfere with any aspect of study conduct / interpretation of results
    20. Donation/ loss of >500 mL of blood or donation of blood product within 56D of dosing (or corresponding blood loss in pediatric population [eg, more than 10% of total blood volume from trauma, surgery, or having blood drawn for testing prior to sc])
    21. Known or suspected presence of significant central nervous system disease/injury.
    22. Have conditions that could affect glucose levels
    23. has evidence of COVID-19 within 2W before enrollment
    24. Pregnant female subjects based on sc and baseline pregnancy tests
    25. With history of major depression, anxiety, or other psychiatric disorders (within last 6 M), requiring active and ongoing medication regimen adjustments including selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, antipsychotics, or lithium.
    Baseline period exclusion criteria include following:
    - Use of glucagon within 24 hours before 1st HM15136 administration - Significant changes to CHI medications during sc - Less than 3 hypoglycemia events/ W before baseline period
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    Safety and tolerability endpoints
    • incidence of adverse event (AE), treatment-emergent AE (TEAE), and serious AE (SAE) for the following:
    ° level of severity
    ° related to/not related to study drug
    ° leading to discontinuation of study drug
    ° AE of special interest (AESI in this study are necrolytic migratory erythema, drug-induced liver injury [hepatic laboratory abnormalities], and salivary glands hypertrophy)
    ° death
    • incidence of clinical laboratory abnormalities
    • immunogenicity
    ° antidrug antibodies (ADAbs)
    ° neutralizing antibodies
    ° antipolyethylene glycol antibodies
    • incidence and severity of clinical findings on physical examination
    • change from baseline in vital signs (blood pressure, heart rate, respiratory rate, and body temperature)
    • change from baseline in 12-lead ECG parameters; the primary ECG endpoint will be QT interval corrected for heart rate using Fridericia’s formula (QTcF)
    Pharmacokinetic endpoints
    • maximum concentration (Cmax)
    • time to reach Cmax (tmax)
    • trough serum concentration (Ctrough)
    • area under the concentration-time curve (AUC), eg, AUC from time 0 to time t (AUC0-t) at
    steady state during the period of injection
    • terminal elimination rate constant (kel)
    • terminal half-life (t1/2)
    • apparent clearance at steady state (CLss/F)
    • apparent volume of distribution at steady state during the terminal phase (Vss/F)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to the Schedule of Assessments (Table 1 Schedule of Assessments for Cohort A and Cohort C) within the protocol.
    E.5.2Secondary end point(s)
    Secondary Endpoint
    • change from baseline in average weekly number and rate of hypoglycemia events at Week 8 (Day 50 to Day 56) by the 7-point SMBG
    ° hypoglycemia event: glucose <70 mg/dL (<3.9 mmol/L)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to the Schedule of Assessments (Table 1 Schedule of Assessments for Cohort A and Cohort C) within the protocol.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Germany
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The EOS is defined as the date of the last visit of the last subject in the study or last scheduled procedure for the last subject in the trial globally.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 13
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 3
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    pediatric population : subjects under 18 years old.
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 16
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-20
    P. End of Trial
    P.End of Trial StatusOngoing
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