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    The EU Clinical Trials Register currently displays   37767   clinical trials with a EudraCT protocol, of which   6190   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2013-004251-21
    Sponsor's Protocol Code Number:HM-EXC-205
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-22
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-004251-21
    A.3Full title of the trial
    A 20-week, double blind, randomized, placebo controlled, parallel group trial to assess the safety and efficacy of HM11260C on body weight in obese subjects without diabetes.
    20 hetes, kettős vak, randomizált, placebo-kontrollált, párhuzamos csoportos vizsgálat a HM11260C biztonságosságának és testsúly terén meglévő hatásosságának vizsgálatára túlsúlyos, nem diabéteszes vizsgálati alanyoknál
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the safety and efficacy of HM11260C on body weight in obese subjects without diabetes.
    A.4.1Sponsor's protocol code numberHM-EXC-205
    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 Pharmaceutical 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 Pharmaceutical 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 Pharmaceutical Co., Ltd.
    B.5.2Functional name of contact pointClinical director’s office
    B.5.3 Address:
    B.5.3.1Street Address45, Bangi-dong Songpa-gu
    B.5.3.2Town/ citySeoul
    B.5.3.3Post code138-724
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82-2-410-9041
    B.5.5Fax number+82-2-410-9278
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHM11260C
    D.3.2Product code HM11260C
    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 INNLanglenatide
    D.3.9.1CAS number 1296200-77-5
    D.3.9.2Current sponsor codeHM11260C
    D.3.9.3Other descriptive nameLong-acting Exendin-4 Analog (LAPS-Exd4)
    D.3.9.4EV Substance CodeSUB16091MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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 Yes
    D. medicinal product typeHM11260C: conjugating the CA Exendin-4(Exendin-4 analog) and the constant region of human immunoglobulin G4 fragment (named as HMC001) via 3.4 KDa linker to make long-acting CA Exendin-4.
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Weight reduction
    E.1.1.1Medical condition in easily understood language
    Weight reduction
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10033307
    E.1.2Term Overweight
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the effect of HM11260C, in combination with a hypocaloric diet, on body weight over the 20 weeks from baseline in obese subjects
    E.2.2Secondary objectives of the trial
    • To assess the safety, tolerability, and immunogenicity of HM11260C, in combination with a hypocaloric diet, over the 20 weeks from baseline in obese subjects
    • To assess the effect of HM11260C, in combination with a hypocaloric diet, on the metabolic profile, i.e., glucose parameters and lipid profile, of obese subjects over the 20 weeks from baseline.
    o Glucose parameters: fasting plasma glucose (FPG), fasting insulin, HbA1c, and c peptide
    o Lipid profile: total cholesterol (TC), low density lipoprotein cholesterol (LDL C), high density lipoprotein cholesterol (HDL C), very low density lipoprotein cholesterol (VLDL C), and triglycerides (TG)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged ≥ 18 and < 65 years at screening
    2. BMI ≥ 30 kg/m2 or ≥ 27 kg/m2, with treated or untreated co morbidity(ies) (e.g., hypertriglyceridemia, dyslipidemia, hypertension, glucose intolerance, and sleep apnea), at screening.
    3. Stable body weight (less than 5% change) for at least 3 months prior to screening
    4. FPG < 126 mg/dL (7 mmol/L)
    5. Considered to be in stable health, as determined by:
    a) physical examination;
    b) a medical history indicating either no clinically significant abnormalities or stable co morbid condition(s);
    c) vital signs within normal ranges or if outside of the normal range are not deemed clinically significant in the opinion of the Investigator;
    d) pre-study clinical laboratory findings within normal range, or if outside of the normal range, not deemed clinically significant in the opinion of the Investigator; and
    e) a 12-lead electrocardiogram (ECG) showing no active ischemia
    6. Not undergoing or in need of treatment for significant chronic disease, with the exception of stable (at least 3 months) treatment for hypertension, hypertriglyceridemia, and dyslipidemia, which is permitted
    7. Female subjects of child-bearing potential must test negative for serum pregnancy at screening and by urine dipstick prior to dosing on the first day of dosing, and agree to use a highly effective method of birth control throughout the study and for at least 3 months after the last dose of study medication. Child bearing potential is defined as women who have not been surgically sterilized for 6 weeks prior to screening or are post menopausal ≤ 1 year. For women who are surgically sterilized or post-menopausal (> 1 year prior to the screening visit), the site will make an effort to retrieve medical records to document sterility. However, the absence of records will not exclude the subject. In the event that medical records cannot be obtained, serum and urine pregnancy testing will be conducted. Post-menopausal status will be confirmed through testing of follicle stimulating hormone (FSH) levels ≥ 40 IU/mL at screening.
    A highly effective method of birth control is considered to be 1 of the following:
    a) An oral or implanted hormonal method of contraception (if it has been used for ≥ 3 months prior to study drug administration) while also using a barrier method (i.e., a condom or a diaphragm);
    b) A hormone or copper intrauterine device if it has been in place for ≥ 3 months prior to study drug administration (subjects using a nonhormonal or copper intrauterine device should also use a barrier method [i.e., a condom or a diaphragm]);
    c) A vasectomised partner;
    d) Total abstinence is acceptable; however, the subject must use a highly effective method of contraception if the subject subsequently decides not to abstain.
    8. Male subjects whose partners are female of child-bearing potential must be surgically sterilized (e.g., vasectomy) for at least 3 months prior to screening or agree to practice highly effective birth control methods (condom and spermicide) during the conduct of the study and for at least 3 months after the last dose of study medication.
    9. Ability and willingness to comply with all protocol procedures (e.g., correct handling of investigational product, compliance with visit schedule and dietary advice, and complete trial related questionnaires)
    10. Written informed consent must be obtained before any study related assessment is performed.
    E.4Principal exclusion criteria
    1. Prior participation in any study of HM11260C.
    2. Pregnant or nursing (lactating) women
    3. BMI > 42 kg/m2
    4. Drug induced obesity
    5. Diabetes mellitus (type 1, 2, or other)
    6. HbA1c > 6.5%
    7. Previous surgical treatment for obesity (e.g., gastric bypass, ileal bypass, gastric banding) or anticipation of surgery during the study period that may interfere with completion or compliance with the protocol, or planned elective hospitalizations
    8. Any known history of severe GI disease or intolerance, gastric emptying abnormality, or inflammatory bowel disease
    9. Any previous GI bleeding or ulceration related to the use of non steroidal anti inflammatory drugs (NSAIDs) within 3 months before screening
    10. Known history of acute or chronic pancreatitis with presence of raised serum amylase and lipase (> 3 times the upper limit of normal [ULN]) at screening
    11. History of suicide attempts or recent history (within 2 years prior to screening) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), antipsychotics, and lithium.
    12. Uncontrolled hypertension, defined as resting blood pressure (BP) > 150/90 mmHg at screening. If elevated, BP will be re-checked on a separate day within the screening period. If elevated on re check, subjects may be rescreened only after being on a stable antihypertensive therapy for 3 months. .
    13. Has clinically significant abnormalities on 12 lead ECG, as determined by the Investigator
    14. History of invasive cardiovascular surgical procedure within 6 months of screening; or severe heart or circulatory disease, within 6 months prior to screening
    15. Personal or known family history of medullary thyroid carcinoma (MTC) or a genetic condition that predisposes to MTC
    16. Abnormal thyroid stimulating hormone (TSH) laboratory value > 1.5 x ULN (ULN 5 mIU/L) value or abnormal TSH value lower than the normal value (< 0.5 mIU/L). Thyroid hormones are not permitted.
    17. Fasting TG > 400 mg/dL.
    18. LDL C > 160 mg/dL.
    19. Liver disease, hepatitis, or clinically significant abnormal hepatic parameters suggestive of hepatic impairment (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase (AST) levels > 2.5 x ULN, or total bilirubin >1.5 x ULN unless the subject has a known history of Gilbert’s syndrome)
    20. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 or has > 60 mL/min/1.73 m2 and <90 mL/min/1.73 m2 with urine albumin to urine creatinine ratio > 30 mg/g. The eGFR will be based on the Cockcroft Gault formula at screening. Subject must not have a prior diagnosis of chronic kidney disease
    21. Calcitonin levels > 20 pg/mL at screening
    22. History of or positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) type 1 or 2 antibody
    23. Use of canabis (recreational or therapeutic) or a positive screen for drugs of abuse, barbiturates, or benzodiazepines that may potentially jeopardize a subject’s study compliance. Subjects who have been prescribed benzodiazepines, or low dose opiates for chronic conditions, may qualify for the study at the discretion of the investigator
    24. A history of alcohol or drug abuse or drug addiction in the previous 12 months. Subjects should limit alcohol use to 14 units per week for women or 21 units per week for men (a unit is 1.5 ounces [44 mL] of 80 proof distilled spirits, 4 ounces [11.8 mL] of wine, or 1.2 ounces [355 mL] of 3 5% beer)
    25. Heavy smoker (smokes more than 10 cigarettes/day or more than 2 cigars/day)
    26. Has lost or donated more than 500 mL of blood within the last 2 months
    27. Use of very-low calorie (1,000 kcal/day) liquid weight loss diet within 6 months
    28. Known history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
    29. Plans to or has had radioactive iodine test with intravenous administration of contrast material within 3 months of screening
    30. Proliferative retinopathy or maculopathy treated within the 6 months before screening or requiring acute treatment
    31. History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years before screening.
    32. Severe neuropathy
    33. Atypical sleep patterns (e.g., those working late night or graveyard shifts)
    34. Any other condition or clinically significant abnormal findings during the physical examination, assessment of medical history (e.g. cognitive impairment) or clinical laboratory test results that, in the opinion of the Investigator, would make the subject unsuitable for the study or would put them at additional risk during participation
    35. Has taken certain medications within the noted time period
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is the body weight (to the nearest 0.1 kg [3.5 oz]), collected from subjects at baseline, Days 1, 8, 15, 22, 36, 50, 78, 106, and 141 during the treatment period.
    The change in body weight from baseline to Week 21 (Day 141) and the number and the proportion of subjects who lose at least 5% of baseline body weight at Week 21 (Day 141) will be used to demonstrate the efficacy of each of the 4 doses of HM11260C versus placebo on fasting body weight reduction.

    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary variable is the body weight (to the nearest 0.1 kg [3.5 oz]), collected from subjects at baseline, Days 1, 8, 15, 22, 36, 50, 78, 106, and 141 during the treatment period.
    The change in body weight from baseline to Week 21 (Day 141) and the number and the proportion of subjects who lose at least 5% of baseline body weight at Week 21 (Day 141) will be used to demonstrate the efficacy of each of the 4 doses of HM11260C versus placebo on fasting body weight reduction.

    E.5.2Secondary end point(s)
    - Glucose Metabolism Parameters (FPG, fasting insulin, HbA1c, c peptide, and glucagon)
    - Serum Lipid Profile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline
    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 No
    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. 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Korea, Republic of
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 270
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 270
    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)
    All patient would be treated as per local guidelines at the discretion of treating physician
    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 Decision2014-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-17
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