[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HK inno.N Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":220},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,40,64,88,112,137,158,178,200],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100645230","an-observational-study-to-evaluate-the-efficacy-and-safety-of-k-cab-tabk-cab-odttegoprazan-in-gerd-patients-100645230",false,"NCT07678177","An Observational Study to Evaluate the Efficacy and Safety of K-CAB Tab.\u002FK-CAB ODT(Tegoprazan) in GERD Patients","A Multi-center, Prospective, Observational Study to Evaluate the Safety and Efficacy of K-CAB Tab.\u002FK-CAB ODT(Tegoprazan) in GERD Patients","Inclusion Criteria:\n\n1. Subjects over 19 years of age as of the date of consent\n2. Subjects with a total score of 8 or more in the Korean Gastroesophageal Reflux Disease Questionnaire (GerdQ) based on Visit 1\n3. Subjects who voluntarily decides to participate and agrees in writing to the consent form of the study\n\nExclusion Criteria:\n\n1. Subjects who have hypersensitivity reactions and a medical history of Benzimidazole or components of the investigational drug\n2. Subjects on Atazanavir, Nelfinavir, or Rilpivirine-containing medications\n3. Pregnant and lactating women","ALL","19 Years",{"count":19,"type":20},5384,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the status of AE and improvement effect of K-CAB Tab\u002FK-CAB ODT(Tegoprazan) 50mg in patients with GERD.",[24],"GERD (Gastroesophageal Reflux Disease)",[26],"IN_TPZ_N03","RECRUITING","2026-06-25",{"date":30,"type":31},"2026-07-01","ACTUAL",{"date":33,"type":31},"2023-03-07",{"date":35,"type":20},"2027-06-30",{"name":37,"class":38},"HK inno.N Corporation","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100643939","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-in-207907-injection-in-elderly-patients-with-sarcopenia-100643939","NCT07668180","A Study to Evaluate the Efficacy and Safety of IN-207907 Injection in Elderly Patients With Sarcopenia","A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of IN-207907 Injection in Elderly Patients With Sarcopenia","Inclusion Criteria:\n\n* Subjects aged ≥ 65 years (for female subjects, those who are medically unable to become pregnant)\n* Subjects diagnosed with sarcopenia in accordance with the Korean Working Group on Sarcopenia (KWGS) guidelines\n* Subjects with a body weight of ≥ 35 kg and a body mass index (BMI) of ≥ 15 kg\u002Fm² and \\\u003C 30 kg\u002Fm²\n* Subjects with a nutritional status screening score of ≥ 8 as assessed by the Mini Nutritional Assessment (MNA) questionnaire\n\nExclusion Criteria:\n\n* Subjects with a history of diseases or surgical procedures that may affect physical activity or function\n* Subjects with underlying muscle disorders, including myopathy or muscular atrophy\n* Subjects with neuromuscular or neurological disorders\n* Subjects with uncontrolled diabetes mellitus, severe renal impairment, uncontrolled thyroid disorders, vitamin D deficiency, severe hepatic impairment, severe cardiac disease, uncontrolled hypertension, respiratory disorders\n* Subjects with clinically significant findings on a 12-lead electrocardiogram (ECG)\n* Subjects who are positive for active hepatitis B, active hepatitis C, syphilis, or human immunodeficiency virus\n* Subjects with a history of malignancy within 5 years\n* Subjects who have received systemic immunosuppressants or immunostimulants\n* Subjects who have undergone treatment with plasmapheresis within 8 weeks\n* Subjects who have received treatment with medications prohibited in this clinical trial within 4 weeks\n* Subjects with hemoglobin levels \\\u003C 10 g\u002FdL\n* Subjects who have undergone surgery requiring general anesthesia within 4 weeks\n* Subjects who are unable to walk or are physically inactive\n* Subjects who are participating in or planning to participate in a separate high-intensity program for increasing muscle mass or strength during the clinical trial period\n* Subjects with severe psychiatric disorders such as major depression, schizophrenia, alcoholism, or drug dependence\n* Subjects with a score of \\\u003C 24 on the Korean version of the Mini Mental State Examination (MMSE-K)\n* Subjects with known allergies or hypersensitivity to the investigational product or its excipients","65 Years",{"count":49,"type":20},100,"INTERVENTIONAL",[52],"PHASE2","The goal of this clinical trial is to learn if intervention can treat sarcopenia in the elderly. Researchers will compare IN-207907 120 mg, 240 mg, 360 mg and placebo to see if SPPB score improves.",[55],"Sarcopenia in Elderly","NOT_YET_RECRUITING","2026-06-19",{"date":28,"type":31},{"date":60,"type":20},"2026-09",{"date":62,"type":20},"2028-02",{"name":37,"class":38},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":50,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":39},"100616914","phase-1-a-study-to-evaluate-the-pharmacokinetics-and-safety-of-in-m00007-and-in-r00007-in-healthy-adult-volunteers-100616914","NCT07311811","A Study to Evaluate the Pharmacokinetics and Safety of IN-M00007 and IN-R00007 in Healthy Adult Volunteers","An Open Label, Randomized, 2-sequence, 2-period, Fasting, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence and Safety of 'IN-M00007' and 'IN-R00007' in Healthy Adult Volunteers","Inclusion Criteria:\n\n1. Healthy adult volunteers aged ≥ 19 and \\\u003C 60 years at screening\n2. Body mass index(BMI) in the range of 18.0 and 30.0 kg\u002F㎡\n\n   * Body weight ≥ 50kg for male\n   * Body weight ≥ 45kg for female\n3. Subjects who do not have significant congenital or chronic diseases and without pathological symptoms or findings based on medical examinations(if necessary, EEG, ECG, chest X-ray, gastroscopy or gastrointestinal radiographic tests)\n4. Determined by the investigator to be eligible for study participation based on the results of screening tests (e.g. hematology test, blood chemistry test, serology test, urinalysis, pregnancy diagnostic tests) conducted according to the IP characteristics\n5. Subjects who voluntarily signed the consent form after receiving detailed explanation and understanding about purpose, details, characteristics of the IP and anticipated adverse events of the study\n6. Subjects who agree to use highly effective methods of contraception(excluding hormonal methods) to preclude the possibility of pregnancy of themselves or their spouse\u002Fpartner from the first IP administration until 14 days after the last administration, and who agrees not to donate sperm or ovum during this period\n\n   * Highly effective contraceptive methods: intrauterine device(IUD), bilateral tubal ligation, a partner who has undergone vasectomy, or sexual abstinence However, periodic abstinence(calendar method, symptothermal method, post-ovulation method), withdrawal intercourse(coitus interruptus), spermicide methods, lactational amenorrhea method, and simultaneous use of female and male condoms are not considered contraceptive methods\n\nExclusion Criteria:\n\n1. Subjects who have taken drugs which can induce(e.g, Barbiturates) or inhibit drug metabolism enzyme within 30 days prior to the start of the study(first IP administration day) or have taken medications that may affect this study within 10 days prior to the start of the study(first IP administration day)\n2. Subjects who have participated in any other clinical study or bioequivalence study and administered IP within 6 months\n3. Subjects who have donated whole blood within 8 weeks prior to the start of the study(first IP administration day) or have donated component blood within 2 weeks prior to the start of the study(first IP administration day)\n4. Subjects with a history of gastrointestinal resection that may affect drug absorption(excluding appendectomy and hernia operation)\n5. Subjects meeting following conditions within 1 month prior to the start of the study(first IP administration day)\n\n   * Alcohol consumption \\> 21 glasses per week for male\n   * Alcohol consumption \\> 14 glasses per week for female\n6. Subjects with the following diseases\n\n   * Subjects with hypersensitivity to the ingredient or components of this drug\n   * Subjects with active liver disease or those with persistently elevated serum aminotransferase levels of unknown cause\n   * Subjects with muscular disorders\n   * Subjects receiving concomitant administration with cyclosporine\n   * Subjects with severe renal impairment or kidney dysfunction\n   * Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption\n7. Subjects with a clinically significant history of mental illness\n8. Pregnant or breastfeeding women if female\n9. Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion\u002Fexclusion criteria",true,"59 Years",{"count":74,"type":20},60,[76],"PHASE1","This study aims to evaluate the Pharmacokinetic (PK) characteristics and safety after a single oral dose administration of IN-M00007 and IN-R00007 in healthy adult volunteers",[79],"Healthy Volunteers","2025-12-30",{"date":82,"type":31},"2025-12-31",{"date":84,"type":20},"2026-01",{"date":86,"type":20},"2026-04",{"name":37,"class":38},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":50,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100616636","phase-3-bridge-study-to-evaluate-the-efficacy-and-safety-of-in-b00009-injection-in-patients-with-t2dm-inadequately-controlled-by-diet-and-exercise-alone-100616636","NCT07308184","Bridge Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone","A Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel, Phase 3 Bridge Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone","Inclusion Criteria:\n\n1. Subjects aged 19 to 75 years at the time of written consent\n2. Subjects with a BMI ≥ 20 kg\u002Fm² and ≤ 35 kg\u002Fm² at the screening visit\n\n   ☞BMI (kg\u002Fm²) = Weight (kg) \u002F Height (m)²\n3. Among subjects who have been diagnosed with T2DM at least 12 weeks ago and have followed a stable diet and exercise program for at least 8 weeks prior to the screening visit, those who meet any of the following criteria:\n\n   * Those who have not administered hypoglycemic agents within the past 12 weeks\n   * Those who have administered oral hypoglycemic agents within the past 12 weeks, but have not administered them within 5 weeks prior to the screening visit\n4. Subjects with HbA1c levels of 7.5% to 11.0% at the screening visit and 7.0% to 10.5% before randomization\n5. Subjects with fasting plasma glucose (FPG) levels ≤ 250 mg\u002FdL (13.9 mmol\u002FL) at the screening visit and pre-randomization testing\n6. Subjects who are able to self-monitor blood glucose levels and record subject diary cards during the study\n7. Subjects who agree to use medically acceptable contraceptive methods (including those medically incapable of pregnancy) during the study\n8. Subjects who are able to understand and follow instructions and participate throughout the study\n\nExclusion Criteria:\n\n1. Subjects who have been diagnosed with type 1 diabetes mellitus (T1DM) or diabetes due to a genetic defect or exocrine pancreatic dysfunction\n2. Subjects who have been administered GLP-1 analogues or DPP-4 inhibitors within 12 weeks prior to the screening visit\n3. Subjects who have used insulin within 24 weeks prior to the screening visit (excluding the short-term use for the treatment of hyperglycemia symptoms within a total of 14 days)\n4. Subjects with a history of diabetic ketoacidosis, hyperosmolar hyperglycemia, or diabetic lactic acidosis within 24 weeks prior to the screening visit\n5. Subjects with a history of severe chronic diabetic complications (proliferative diabetic retinopathy or diabetic maculopathy, diabetic peripheral neuropathy, etc.) within 24 weeks prior to the screening visit\n6. Subjects with a history of level 3 severe hypoglycemia within 24 weeks, or two or more events of level 2 hypoglycemia (blood glucose \\\u003C 54 mg\u002FdL) within 4 weeks prior to the screening visit\n7. Subjects with a history of severe trauma, infection, or surgery that may affect glycemic control within 4 weeks prior to the screening visit\n8. Subjects with a history of uncontrolled hyperthyroidism or hypothyroidism (However, those with 0.4 uIU\u002FmL ≤ TSH ≤ 6.8 uIU\u002FmL at the screening visit, who have been taking a stable dose of thyroid hormone medication for the past 12 weeks, and whose dose is unlikely to change during the study can participate.)\n9. Subjects with a history (including family history) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)\n10. Subjects who have received medical or non-medical weight management, including weight management medications or products, within 12 weeks prior to the screening visit, or whose weight percent change confirmed by clinical interview exceeded 5%\n11. Subjects with at least one of the following medical histories confirmed within 24 weeks prior to the screening visit\n\n    * NYHA class III or IV heart failure\n    * Coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI)\n    * Ischemic heart disease (acute myocardial infarction, unstable angina, etc.)\n    * Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), transient ischemic attack (TIA)\n12. Subjects with a history of uncontrolled respiratory disease (chronic obstructive pulmonary disease, bronchial asthma, active tuberculosis, etc.) within 24 weeks prior to the screening visit\n13. Subjects who have had severe gastrointestinal disease (active ulcer, etc.), gastrointestinal surgery, or clinically significant abnormal gastric emptying, or those who have chronically used medications that directly affect gastrointestinal motility within 24 weeks prior to the screening visit (However, those with a history of appendectomy or cholecystectomy are eligible to participate)\n14. Subjects with a history of acute or chronic pancreatitis (e.g., acute and chronic pancreatitis, symptomatic cholecystitis, pancreatic injury, etc.)\n15. Subjects with a history of malignant tumor within the past 5 years\n\n    * Those who have been assessed as having achieved complete remission (CR, pCR) of the tumor and have remained free of recurrence for ≥5 years from the date of assessment are eligible to participate\n    * Those with a history of thyroid cancer, excluding medullary thyroid carcinoma (MTC), carcinoma in situ of cervix, or basal cell or squamous cell carcinoma within the past 5 years are eligible to participate\n16. Subjects with a history of major depressive disorder, anxiety disorder, or other severe mental illness (e.g., schizophrenia, bipolar disorder, etc.) in an unstable state\n17. Subjects who tested positive for HBsAg, HCV antibody, or HIV antibody at the screening visit (However, those who tested positive for HCV-Ab but negative for HCV-RNA may participate.)\n18. Subjects whose test results meet the following at the screening visit and pre-randomization testing:\n\n    * Uncontrolled hypertension: siSBP≥160 mmHg or siDBP≥100 mmHg\n    * AST or ALT \\> 3 times the upper limit of normal , total bilirubin \\> 2 times the upper limit of normal\n    * Amylase or Lipase \\> 3 times the upper limit of normal\n    * eGFR ≤ 45mL\u002Fmin\u002F1.73m²\n    * TG \\> 500 mg\u002FdL (or 5.65 mmol\u002FL)\n    * Fasting C-peptide \\\u003C 0.6 ng\u002FmL (or 0.2 nmol\u002FL)\n    * Hemoglobin \\\u003C11.0 g\u002FdL (male), \\\u003C10.0 g\u002FdL (female)\n    * Calcitonin ≥ 100 ng\u002FL (or 100 pg\u002FmL)\n19. Subjects with hematologic conditions (e.g., hemolytic anemia, hemoglobinopathies) that may interfere with HbA1c measurements at the screening visit and pre-randomization testing\n20. Subjects with a history of alcoholism or substance abuse\n21. Subjects who have taken systemic steroids or growth hormones for 7 days or more (including oral and intravenous administration) within 8 weeks prior to the screening visit\n22. Subjects with a history of resistance or hypersensitivity to the drugs in the same class as the investigational product\n23. Subjects who have received other investigational products or used investigational devices within 12 weeks prior to the screening visit\n24. Subjects who have donated blood, had significant bleeding (\\>400 mL), or received blood transfusion or blood products within 12 weeks prior to the screening visit\n25. Subjects with a history of nonarteritic anterior ischemic optic neuropathy (NAION)\n26. Subjects with a positive pregnancy test, pregnant women, or lactating women\n27. Subjects who deemed ineligible as subjects by the investigator for other reasons","75 Years",{"count":97,"type":20},110,[99],"PHASE3","This Phase 3 Bridge study is designed to evaluate the efficacy and safety of IN-B00009 Injection in Patients with T2DM Inadequately Controlled by Diet and Exercise Alone",[102,103],"Diabetes (DM)","Diabetes Mellitus Type 2","2025-12-15",{"date":106,"type":31},"2025-12-29",{"date":108,"type":20},"2025-12",{"date":110,"type":20},"2027-09",{"name":37,"class":38},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":71,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":50,"phases":122,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":39},"100614293","phase-1-a-study-to-evaluate-the-pharmacokinetics-and-food-effect-of-in-m00002-tablet-in-healthy-adult-volunteers-100614293","NCT07277712","A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers","A Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetics Following Administration of IN-M00002 Tablet and Co-administration of Tegoprazan and Naproxen, and to Evaluate Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers","Inclusion Criteria:\n\n* Healthy adult aged ≥ 19 and ≤ 55 year-old at screening\n* Body mass index (BMI) ≥ 19.0 kg\u002Fm2 and ≤ 27.0 kg\u002Fm2 with a body weight ≥ 45 kg at screening\n* Those determined to be eligible for this study based on the findings of screening such as clinical laboratory tests (hematological test, blood chemistry test, blood coagulation test, urinalysis, test for viruses\u002Fbacteria, etc.), vital signs, and electrocardiogram (ECG) which are performed by the investigator according to the properties of medicines\n* Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening\n* Those with a capability\u002Fwillingness to participate throughout the study\n\nExclusion Criteria:\n\n* Medical history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological, musculoskeletal, oncological, or immune disease (except for history of simple dental treatment such as tartar, impacted teeth, and third molar teeth)\n* Previous history of gastrointestinal disease (esophageal disease such as esophageal achalasia or esophageal stricture, inflammatory bowel disease (Crohn's disease, ulcerative colitis)) or surgery (except for simple appendectomy, hernia surgery, tooth extraction, etc.) which may affect drug absorption\n* Sitting systolic blood pressure \\\u003C 90 mmHg or ≥ 140 mmHg or diastolic blood pressure \\\u003C 60 mmHg or ≥ 90 mmHg at screening\n* Following findings of clinical laboratory tests:\n\n  * ALT or AST value \\> twice the upper limit of normal (ULN)\n* History of periodic alcohol consumption exceeding 210 g\u002Fweek within 6 months prior to screening (beer (5%) 1 glass (250 mL) = 10 g, soju (20%) 1 glass (50 mL) = 8 g, wine (12%) 1 glass (125 mL) = 12 g)\n* Has taken any other investigational product within 6 months prior to the first dose of investigational product\n* History of serious alcohol or drug misuse and abuse within 1 year prior to screening\n* Administration of drugs known to markedly induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose of the investigational product\n* Daily use of ≥ 20 cigarettes within 6 months prior to screening\n* Administration of a prescription or non-prescription drug within 10 days prior to the first dose of the investigational product\n* Whole blood donation within 2 months prior to the first dose of the investigational product or apheresis donation within 1 month prior to the first dose of the investigational product\n* Subjects who received a blood transfusion within 1 month prior to the first dose of the investigational product\n* Those who may be put at an increased risk due to the administration of the investigational product and study participation or have a severe acute\u002Fchronic medical or mental condition which may interfere with the interpretation of study results\n* Subjects with a history of hypersensitivity (e.g., asthma, rhinitis, nasal polyps, urticaria, or allergic reactions) to the components of tegoprazan or naproxen, benzimidazole derivatives, aspirin, or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)\n* Subjects currently receiving medications containing atazanavir, nelfinavir, or rilpivirine\n* Women with a positive pregnancy test, pregnant, or breastfeeding\n* Subjects are unable to use a highly effective method of contraception (e.g., correctly placed intrauterine device(IUD), sterilization surgery (vasectomy, tubal ligation, etc.))\n* Subjects unable to consume a high-fat diet provided during Part B of the clinical trial\n* Subjects who are considered ineligible to participate in this study at the discretion of the investigator","55 Years",{"count":121,"type":20},74,[76],"This study aims to evaluate the pharmacokinetic (PK) following administration of IN-M00002 tablet and co-administration of tegoprazan and naproxen, and to evaluate food-effect of IN-M00002 tablet in healthy adult volunteers",[125],"Healthy Volunteer",[127,128],"pharmacokinetic","food-effect","2025-11-30",{"date":131,"type":31},"2025-12-11",{"date":133,"type":20},"2025-12-27",{"date":135,"type":20},"2026-09-30",{"name":37,"class":38},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":95,"enrollmentInfo":144,"targetDuration":4,"studyType":50,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100607723","phase-3-study-to-evaluate-the-efficacy-and-safety-of-in-b00009-injection-in-adults-with-obesity-or-overweight-without-diabetes-mellitus-100607723","NCT07192263","Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus","A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus","Inclusion Criteria:\n\n1. Aged 19 to 75 years as of the date of written consent\n2. Those who meet any of the following obesity criteria at the screening visit\n\n   * BMI ≥ 30 kg\u002Fm2\n   * 27 kg\u002Fm2 ≤ BMI \\\u003C 30 kg\u002Fm2 with at least one risk factor or comorbidity\n\n     * BMI (kg\u002Fm2) = weight (kg) \u002F height (m)2\n\n       * Hypertension: Taking antihypertensive medication or sitSBP ≥ 140 mmHg or sitDBP ≥ 90 mmHg\n       * Dyslipidemia: Taking dyslipidemia medication or Total Cholesterol ≥ 240mg\u002FdL or LDL-C ≥ 160 mg\u002FdL or TG ≥ 200 mg\u002FdL or HDL-C \\\u003C 40 mg\u002FdL\n       * Obstructive sleep apnea\n       * Cardiovascular and cerebrovascular diseases: Ischemic cardiovascular and cerebrovascular diseases not corresponding to exclusion criterion 17, heart failure of NYHA Class I to III, etc.\n       * Prediabetes: 100 mg\u002FdL ≤ FPG ≤ 125 mg\u002FdL or 140 mg\u002FdL ≤ PG ≤ 199 mg\u002FdL at 2 hours after 75 g oral glucose load or 5.7% ≤ HbA1c ≤ 6.4%\n3. Self-reported history of at least one failed attempt at weight control using diet and exercise therapy prior to the screening visit\n4. Able to agree to and follow the reduced-calorie diet and exercise therapy recommended in this study during the study period\n5. Agrees to use a medically appropriate method of contraception (including medically infertile conditions) during the study period\n\nExclusion Criteria:\n\n1. Body weight change exceeding 5 kg within 3 months of the screening visit\n2. Diabetes (Type 1, Type 2, etc.) or HbA1c ≥ 6.5% at the screening visit\n3. Received any of the following medications or treatments within 3 months of the screening visit\n\n   ① Obesity-related medications (such as GLP-1 receptor agonists) or medications including over-the-counter drugs, herbal medicines, or health functional foods for weight control\n\n   ② Received hypoglycemic agent or requires continuous administration during the study period\n\n   ③ Received systemic steroids for 30 consecutive days or more, or requires continuous administration during the study period\n\n   ④ Received other medications that cause significant body weight changes or requires continuous administration during the study period (e.g.: antipsychotics, tricyclic antidepressants, selective serotonin reuptake inhibitors, noradrenergic and specific serotonergic antidepressant, mood stabilizers (lithium), anticonvulsants, serotonin antagonists, first-generation antihistamines, etc.)\n4. Diagnosed with obesity due to endocrine disorders (hypothalamic obesity, Cushing's syndrome, insulinoma, adult growth hormone deficiency, hypothyroidism, etc.)\n5. Diagnosed with obesity due to genetic variations and congenital disorders\n\n   * Obesity-causing genes: ob, db, Proopiomelanocortin (POMC), Melanocortin 4 receptor (MC4R) genes, etc.\n   * Congenital disorders: Prader-Willi syndrome, Laurence-Moon-Biedl syndrome, Alström syndrome, Cohen syndrome, Carpenter syndrome, etc.\n6. History of bariatric surgery (e.g., adjustable gastric banding, sleeve gastrectomy, Roux-en-Y gastric bypass, biliopancreatic diversion\u002Fduodenal switch, etc.) or device procedures, or plans for such during the study period\n\n   * However, those who have had devices (e.g., gastric band, intragastric balloon) removed for more than 1 year can participate\n   * Those who have had liposuction or abdominoplasty for more than 1 year can participate\n7. Clinically significant gastrointestinal disorders (e.g., gastroparesis, gastric outlet obstruction, peptic ulcer, severe gastroesophageal reflux disease)\n8. History (including family history) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or results of clinical laboratory test at the screening visit meeting the following:\n\n   * Calcitonin ≥ 100 ng\u002FL\n   * TSH \\\u003C 0.6 mIU\u002FL or TSH \\> 6.8 mIU\u002FL (However, subjects being treated for hypothyroidism with 0.6 mIU\u002FL ≤ TSH ≤ 6.8 mIU\u002FL, taking stable doses of thyroid hormonal preparation for 3 months prior to the screening visit and unlikely to have dose changes during the study period can participate)\n9. History of acute or chronic pancreatitis, or results of clinical laboratory test at the screening visit meeting the following:\n\n   \\- Amylase or Lipase \\> 3 times the upper limit of normal\n10. Severe hepatic impairment or results of clinical laboratory test at the screening visit meeting the following:\n\n    \\- AST or ALT \\> 3 times the upper limit of normal or Total bilirubin \\> 2 times the upper limit of normal\n11. Severe renal impairment (eGFR \\\u003C 30mL\u002Fmin\u002F1.73m2)\n12. Uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg) at the screening visit\n13. Answered \"yes\" to question 4 or 5 in the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or history of suicide attempt\n14. Score of 15 or higher on the Patient Health Questionnaire-9 (PHQ-9) at the screening visit, or history of major depressive disorder with unstable state, anxiety, or other severe psychiatric disorders (schizophrenia, bipolar disorder, etc.) within 2 years\n15. History of alcohol addiction or drug abuse within 3 months of the screening visit\n16. History of malignant tumor within the last 5 years\n\n    * Those who have been determined as complete remission (CR, pCR) of the tumor and had no relapse for 5 years or more from the date of assessment can participate\n    * Those with a history of thyroid cancer (excluding MTC), basal cell and squamous cell skin cancer within the last 5 years can participate\n17. Any of the following medical histories confirmed within 3 months of the screening visit\n\n    * Heart failure of NYHA class IV\n    * Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI)\n    * Ischemic heart disease (acute myocardial infarction, unstable angina, etc.). However, if the condition has been stable for 6 months or more from the screening visit, participation is possible at the investigator's discretion\n    * Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), transient ischemic attack (TIA). However, if the condition has been stable for 6 months or more from the screening visit, participation is possible at the investigator's discretion\n18. History of non-arteritic anterior ischemic optic neuropathy (NAION)\n19. History of resistance or hypersensitivity to investigational product class drugs (GLP analogues) or history of multi-drug allergies\n20. Requires administration of contraindicated medications during the study period\n21. Received other investigational products within 30 days or 5 times the half-life (whichever is longer) if the half-life is known, prior to the screening visit\n22. Positive for HBsAg, HCV antibody, or HIV antibody at the screening visit\n\n    \\- However, those who are HCV-Ab positive but confirmed negative in HCV-RNA test can participate\n23. Hematological conditions that may interfere with HbA1c measurement (e.g.: hemolytic anemia, hemoglobinopathies)\n24. Scheduled for surgery requiring hospitalization during the study period or requires surgical treatment\n25. Positive pregnancy test, pregnant or lactating women\n26. Considered inappropriate as a study subject by the investigator for other reasons",{"count":145,"type":20},300,[99],"This Phase 3 study is designed to evaluate the efficacy and safety of IN-B00009 injection in adults with obesity or overweight without diabetes mellitus",[149],"Obesity &Amp; Overweight","2025-09-21",{"date":152,"type":31},"2025-09-25",{"date":154,"type":20},"2025-09-22",{"date":156,"type":20},"2027-09-30",{"name":37,"class":38},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":50,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":177,"locationsCount":4},"100598606","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-in-115314-ointment-in-mild-to-moderate-atopic-dermatitis-adult-patients-100598606","NCT07073677","A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients","A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients","Inclusion Criteria:\n\n1. Adult volunteers aged 19 or older when the informed consent is obtained.\n2. Confirmed diagnosis of AD according the criteria of Hanifin and Rajka (1980).\n3. AD lesions that can be applied by investigational product\n4. AD diagnosed by EASI score of mild (EASI \\\u003C 16) or moderate (16 ≤ EASI \\\u003C\n\n23\\) at screening. 5) Subjects who Investigator Global Assessment (IGA) of 2 to 3 at screening 6) Subjects who have a history of AD at least 12 months prior to screening and who have not improved or worsened the disease for at least one month prior to screening 7) Subjects who voluntarily decide to participate and agree to comply with the requirements\n\nExclusion Criteria:\n\n1. Subjects who have the following prior\u002Fcurrent history in addition to evidence or history of clinically significant skin disorders other than AD ( e.g., psoriasis, contact dermatitis, erythroderma)\n2. Subjects who have the following prior\u002Fcurrent history in addition to evidence or history of clinically significant skin disorders (e.g., hepatic, renal, Cardiovascular, respiratory, endocrine, neurological, hematological, immunological or immunodeficiency disease)\n3. Subjects who have a history of malignant tumors within 5 years at screening (but, those who have passed five years without recurrence after active tumor treatment (surgery, chemotherapy, radiation therapy, etc.) can participate.)\n4. Subjects who have clinically significant systemic or local skin infections or clinical signs of such infections within one week prior to the expeced initial application date (e.g., herpes simplex, shingles, chickenpox)\n5. Subjects who have taken systemic anti-inflammatory for chronic or acute inflammatory disease within 2 weeks prior to the expected initial application date\n6. Subjects who have a history of clinical significant hypersensitivity reactions to Investigational product , other drugs (aspirin, penicillin antibiotics, macrolide antibiotics, etc.) and moisturizers provided by sponsor (anaphylaxis or angioedema, etc.)\n7. Subjects who have administered the following drugs within the specified period before the expected initial application date; subjects who are expected to be administered within the clinical trial period; subjects who are unable to stop administration Biological agents that may affect signs and symptoms of AD within 12 weeks (e.g., dupilumab)\n\n   The following medications and treatments that may affect the signs and symptoms of atopic dermatitis within 4 weeks:\n   * Systemic immunosuppressants\u002Fimmunosuppressants\n   * Oral Janus kinase (JAK) inhibitor medication\n   * a live vaccine\n   * systemic retinoid\n   * phototherapy treatment\n   * Systemic corticosteroids\n\n   The following medications and treatments that may affect the signs and symptoms of atopic dermatitis within two weeks:\n   * a systemic anti-inflammatory drug\n   * systemic anti-microbial agents\n   * bleach treatment\n\n   The following medications that may affect the signs and symptoms of atopic dermatitis within one week:\n   * topical corticosteroids\n   * topical calcineurin inhibitor\n   * topical antihistamines\n   * a topical anti-microbial agent\n   * a topical PDE-4 inhibitor\n   * topical retinoid\n   * Oral antihistamines\n8. Subjects who have clinically significant findings on 12-lead ECG at screening\n9. The following clinically significant findings on laboratory examination at screening\n\n   * Hb \\\u003C 10 g\u002FdL\n   * Platelet or ANC level \\\u003C 0.5 x lower limit of normal\n   * AST, ALT, ALP, γ-GTP is ≥ 2 or total bilirubin level is ≥ 1.5 x upper limit of normal;\n   * Serum creatinine level is ≥ 2 x upper limit of normal;\n   * Positive anti-HCV, HBs Ag, HIV Ag\u002FAb, or IGRA test.\n10. Subjects who have uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg)\n11. Subjects who have history of drug or alcohol abuse in 56 weeks at screening\n12. Subjects who have donated whole blood or apheresis within 4 weeks prior to the expected initial application date or received blood transfusion within 4 weeks prior to the expected initial application date, or subjects who cannot continuously abstain from blood donation over a period from the informed consent to PSV.\n13. Subjects who have participated in other clinical trials within 4 weeks prior to the expected initial application date\n14. Subjects who have scheduled surgery requiring hospitalization or requires surgical treatment over the clinical trial\n15. Subjects or spouses (or partners) who have a plan for pregnancy or although unplanned pregnancy, are unable to use a highly effective method of contraception over a period from the informed consent to 90 days after the last dose of investigational product.\n16. Pregnant or lactating woman\n17. Naive in atopic dermatitis treatment\n18. Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion\u002Fexclusion criteria.",{"count":166,"type":20},162,[52],"This study aims to evaluate the efficacy and safety of IN-115314 Ointment in mild to moderate atopic dermatitis adult patients",[170],"Mild to Moderate Atopic Dermatitis","2025-07-09",{"date":173,"type":31},"2025-07-18",{"date":175,"type":20},"2025-07",{"date":135,"type":20},{"name":37,"class":38},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":71,"sex":16,"minAge":17,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":50,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":39},"100572718","phase-1-this-study-aims-to-evaluate-the-safety-tolerability-pharmacokinetic-and-pharmacodynamic-properties-and-food-effect-of-in-114199-in-healthy-participants-100572718","NCT06736912","This Study Aims to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties and Food Effect of IN-114199 in Healthy Participants","A Randomized, Double-blind, Placebo-controlled, Single\u002Fmultiple Dosing, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety\u002Ftolerability, Pharmacokinetic\u002Fpharmacodynamic Characteristics and Food Effect After Oral Administration of IN-114199 in Healthy Participants","Inclusion Criteria:\n\n* Healthy adults aged ≥ 19 years and ≤ 63 years on the date of the written informed consent\n* Healthy subjects were defined as individuals who defecated almost every day for ≥ 6 months\n* Body weight of ≥ 40.0 kg and ≤ 100.0 kg, with body mass index (BMI) of ≥ 18.5 kg\u002Fm2 and ≤ 29.9 kg\u002Fm2 at the time of screening\n* Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening procedure.\n* Those who are judged eligible for this study upon judgment of the investigator in screening tests established depending on the characteristics of investigational product (examinations by interview, clinical laboratory test, physical examinations, etc.).\n\nExclusion Criteria:\n\n* Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease\n* Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease\n* Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity\n* Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)\n* Subjects who have history of drug abuse, or who have a positive urine test for drugs of abuse.\n* Blood AST(SGOT), and ALT(SGPT) \\> 60 IU\u002FL at the screening test\n* Showing the following findings on ECG at the screening test: QT \\> 480 msec(all), QTcB\\>450(male), QTcB\\>470(female)\n* Subjects who have taken any drugs known to significantly induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 1 month prior to the expected initial application date.\n* Subjects who have participated in other clinical trials within 6 months prior to the expected initial application date\n* Subjects who have history of regular alcohol consumption exceeding 21 units\u002Fweek (1 unit = 10 g = 12.5 mL of pure alcohol) or subjects who cannot avoid drinking alcohol from 3 days prior to the expected initial application date to the discharge\n* Subjects who have history of average use of 10 cigarettes daily\n* Subjects who consumed caffeine-containing food (coffee, green tea, black tea, carbonated beverage, coffee-flavored milk, tonics, etc.) or subjects who cannot avoid drinking caffeine-containing food from 3 days prior to the expected initial application date to the discharge\n* Subjects are unable to use a highly effective method of contraception (e.g., correctly placed intrauterine device(IUD), sterilization surgery (vasectomy, tubal ligation, etc.))\n* Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion\u002Fexclusion criteria.","63 Years",{"count":187,"type":20},80,[76],"This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants",[191],"Chronic Idiopathic Constipation","2024-12-15",{"date":194,"type":31},"2024-12-17",{"date":196,"type":20},"2024-12-16",{"date":198,"type":20},"2025-11-11",{"name":37,"class":38},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":39},"100546024","long-term-observational-study-to-evaluate-the-dfs-and-os-of-adjuvant-folfirinox-regimen-in-pancreatic-cancer-patients-100546024","NCT06389552","Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients","A Long-term Follow-up Study of FOLFIRINOX Regimen as Adjuvant Therapy in Pancreatic Cancer Patients After Curative Surgery: Multi-center, Prospective","Inclusion Criteria:\n\n* Age over 19 at the time of obtaining the informed consent form\n* Planning to FOLFIRINOX as adjuvant therapy after pancreatic cancer surgery\n* ECOG 0 or 1\n* Scheduled to RO or R1 resection\n* Organ function capable of chemotherapy\n\nExclusion Criteria:\n\n* FOLFIRINOX contraindications among the drug approval requirements\n* Palliative Therapy\n* Experienced toxic reactions or Hypersensitivity reactions of FOLFIRINOX",{"count":208,"type":20},36,"This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery.",[211],"Adjuvant Chemotherapy","2024-04-24",{"date":214,"type":31},"2024-04-29",{"date":216,"type":31},"2023-09-25",{"date":218,"type":20},"2027-12",{"name":37,"class":38},""]