[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Myopharm Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100603660","phase-2-triglytza-versus-metformin-in-obese-adult-type-2-diabetes-t2dm-patients-over-24-weeks-of-treatment-100603660",false,"NCT07139405","TRIGLYTZA® VERSUS METFORMIN IN OBESE ADULT TYPE 2 DIABETES (T2DM) PATIENTS OVER 24 WEEKS OF TREATMENT","A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, PHASE II TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND SUPERIORITY OF TRIGLYTZA® OVER METFORMIN IN PATIENTS WITH INADEQUATE GLYCEMIC CONTROL OVER 24 WEEKS OF TREATMENT","RESILIENCE","Inclusion Criteria:\n\n1. Males and females, age 18 and ≤70 at time of screening visit\n2. WOCBP must have negative serum or urine pregnancy test (min sensitivity 25 IU\u002FL or equivalent HCG) within 24 hours prior to the start of the study\n3. Women must not be breastfeeding\n4. Inadequate BG control with Metformin defined as a screening HbA1c of ≥7.0 and ≤ 10.5 at the screening visit\n5. Subjects should have been taking the same daily dose of Metformin for at least 8 weeks prior to the enrolment visit and subjects must not receive other antihyperglycemic medications within the 12 weeks prior to screening\n6. FPG ≥140 mg\u002FdL\n7. BMI ≥28 and ≤40\n8. Grade 1 hypertension defined as 140-159 systolic and 90-99 diastolic mmHg if patients is not receiving anti-hypertensive medication at the time of screening \u002F or has never received anti-hypertensive medication.\n\n   If patient is receiving anti-hypertensive medication at the time of screening and their BP is controlled, BP should be within the normal range of \\\u003C120-139 systolic and \\\u003C80-89 diastolic.\n\n   Patients receiving anti-hypertensive medication at the time of screening and for which their hypertension is uncontrolled, will be excluded\n9. eGFR ≥ 60 ml\u002Fmin\n\nExclusion Criteria:\n\n1. Patients with Type 1 Diabetes\n2. Patients with history of ketoacidosis\n3. Subjects at serious risk of GI adverse events per the discretion of the study site investigator (e.g current or recent history of GI bleeding ulceration, or perforation)\n4. Subjects with a planned radiologic study with IV contrast, surgery, or other planned procedures that may predispose them to metformin-associated lactic acidosis\n5. Subjects with a history of uncontrolled hyperglycemia (\\>15.0 mmol\u002FL) after an overnight fast that required rescue therapy\n6. Impaired kidney function defined as eGFR ≤60 mL\u002Fmin\n7. Subjects taking any prohibited medications.\n8. Any of the following cardiovascular (CV)\u002Fvascular diseases within 3 months of the screening visit:\n\n   1. Myocardial infarction (MI)\n   2. Cardiac surgery or revascularization (coronary artery bypass surgery, Coronary Artery Bypass Graft \\[(CABG\\]\u002FPercutaneous transluminal coronary angioplasty (PTCA)\\]\n   3. Unstable angina\n   4. Unstable congestive heart failure (CHF)\n   5. Transient ischemic attack (TIA) or significant cerebrovascular disease\n   6. Unstable or previously diagnosed arrhythmia\n   7. Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute heart failure and\u002For known left ventricular ejection fraction of ≤40%.\n   8. Acute coronary syndrome, stroke or transient ischemic attack within 3 months prior to the informed consent\n9. Previous bariatric surgery\n10. Previous bariatric surgery\n11. Treatment with anti-obesity drugs within 3 months prior to screening visit\n12. Subjects with COPD\n13. Subjects with active liver disease\n14. Subjects with active renal disease\n15. Subjects with autoimmune diseases e.g. Lupus, Psoriasis\n16. Subjects with HIV \u002F AIDS\n17. Subjects with Hematological and Oncological Diseases\u002FConditions\n18. Haemoglobin \\\u003C11.0 g\u002FdL (110 g\u002FL) for men; haemoglobin \\\u003C10.0 g\u002FdL (100 g\u002FL) for women\n19. Subjects with chronic disease e.g. Cancer, Epilepsy, Alzheimer, Parkinson\n20. Subjects with abnormal free T4\n21. Subjects with serious active infection","ALL","18 Years","70 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Type 2 diabetes (T2DM) is still very difficult to treat because current medicines mostly help with symptoms but don't stop the damage happening inside the pancreas. Many people who start on common treatments like Metformin, and even newer drugs like Ozempic, eventually stop responding to them. This is because these drugs don't address the real problem: the gradual loss of the pancreas' ability to make insulin and the body's increasing resistance to it.\n\nMyopharm is developing a new treatment called TriGlytza®, which combines existing medicines (Celecoxib and Valsartan) with Metformin. This new approach is designed to target the inflammation and biological pathways that cause ongoing damage in Type 2 diabetes, aiming to protect the pancreas and reduce insulin resistance. Early animal studies and past clinical trials with the individual drugs show promising results.\n\nThe number of people with Type 2 diabetes is expected to double by 2045, and the disease brings huge health and financial costs. It also raises the risk of heart disease, stroke, kidney damage, nerve problems, vision loss, certain cancers, and even conditions like Alzheimer's. Because of this, a treatment that addresses the root causes rather than just symptoms could make a major difference.\n\nTriGlytza® aims to provide a safe, affordable, and more effective long-term treatment than current options, helping people manage their diabetes better and avoid related health problems.",[28],"Type 2 Diabetes (T2DM)",[30,31,32,33,34,35],"Type 2 Diabetes","Diabetes","Metformin","Myopharm","Valsartan","Celecoxcib","NOT_YET_RECRUITING","2025-08-17",{"date":39,"type":40},"2025-08-24","ACTUAL",{"date":42,"type":22},"2026-02",{"date":44,"type":22},"2028-06",{"name":46,"class":47},"Myopharm Limited","OTHER",""]