[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631577":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":209,"collaborators":25,"id":211,"slug":212,"hasResults":213,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":25,"eligibilityCriteria":217,"healthyVolunteers":213,"sex":218,"minAge":219,"maxAge":220,"enrollmentInfo":221,"targetDuration":25,"studyType":224,"phases":225,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},{"fullName":5,"class":6},"Biomea Fusion Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: icovamenib 100 mg","EXPERIMENTAL","icovamenib 100 mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks.\n\nAt Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks",[13],"Drug: icovamenib 100mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B: placebo matching 100 mg","PLACEBO_COMPARATOR","placebo matching 100mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks.\n\nAt Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks",[19],"Drug: Placebo",[21,26],{"type":22,"name":23,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","icovamenib 100mg",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Matching placebo",[15],[31],{"name":5,"role":32,"phone":33,"phoneExt":25,"email":34},"CONTACT","1-844-245-0490","clinicaltrials@biomeafusion.com",[36,50,60,69,77,86,95,105,114,123,133,143,153,163,172,181,190,199],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"Central Research Associates, LLC dba Flourish Research","RECRUITING","Birmingham","Alabama","35205","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-86.80249,33.52066,{"lat":48,"lon":47},{"facility":51,"status":38,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":25},"Hope Clinical Research","Canoga Park","California","91303",{"type":45,"coordinates":56},[57,58],-118.59814,34.20112,{"lat":58,"lon":57},{"facility":61,"status":38,"city":62,"state":53,"zip":63,"country":42,"countryCode":43,"cosmosGeoPoint":64,"geoPoint":68,"contacts":25},"Ark Clinical Research","Fountain Valley","92708",{"type":45,"coordinates":65},[66,67],-117.95367,33.70918,{"lat":67,"lon":66},{"facility":61,"status":38,"city":70,"state":53,"zip":71,"country":42,"countryCode":43,"cosmosGeoPoint":72,"geoPoint":76,"contacts":25},"Long Beach","90815",{"type":45,"coordinates":73},[74,75],-118.18923,33.76696,{"lat":75,"lon":74},{"facility":78,"status":38,"city":79,"state":53,"zip":80,"country":42,"countryCode":43,"cosmosGeoPoint":81,"geoPoint":85,"contacts":25},"Catalina Research Institute, LLC","Montclair","91763",{"type":45,"coordinates":82},[83,84],-117.68978,34.07751,{"lat":84,"lon":83},{"facility":87,"status":38,"city":88,"state":53,"zip":89,"country":42,"countryCode":43,"cosmosGeoPoint":90,"geoPoint":94,"contacts":25},"Paradigm Clinical Research Centers, LLC","San Diego","92108",{"type":45,"coordinates":91},[92,93],-117.16472,32.71571,{"lat":93,"lon":92},{"facility":96,"status":38,"city":97,"state":98,"zip":99,"country":42,"countryCode":43,"cosmosGeoPoint":100,"geoPoint":104,"contacts":25},"Southwest General Healthcare Center","Fort Myers","Florida","33907",{"type":45,"coordinates":101},[102,103],-81.84059,26.62168,{"lat":103,"lon":102},{"facility":106,"status":38,"city":107,"state":98,"zip":108,"country":42,"countryCode":43,"cosmosGeoPoint":109,"geoPoint":113,"contacts":25},"Panax Clinical Research","Miami Lakes","33014",{"type":45,"coordinates":110},[111,112],-80.30866,25.90871,{"lat":112,"lon":111},{"facility":115,"status":38,"city":116,"state":98,"zip":117,"country":42,"countryCode":43,"cosmosGeoPoint":118,"geoPoint":122,"contacts":25},"Clinical Site Partners, LLC dba Flourish Research","Winter Park","32789",{"type":45,"coordinates":119},[120,121],-81.33924,28.6,{"lat":121,"lon":120},{"facility":124,"status":38,"city":125,"state":126,"zip":127,"country":42,"countryCode":43,"cosmosGeoPoint":128,"geoPoint":132,"contacts":25},"David Kavtaradze MD, Inc","Cordele","Georgia","31015",{"type":45,"coordinates":129},[130,131],-83.78239,31.96351,{"lat":131,"lon":130},{"facility":134,"status":38,"city":135,"state":136,"zip":137,"country":42,"countryCode":43,"cosmosGeoPoint":138,"geoPoint":142,"contacts":25},"Excel Clinical Research","Las Vegas","Nevada","89109",{"type":45,"coordinates":139},[140,141],-115.13722,36.17497,{"lat":141,"lon":140},{"facility":144,"status":38,"city":145,"state":146,"zip":147,"country":42,"countryCode":43,"cosmosGeoPoint":148,"geoPoint":152,"contacts":25},"Diabetes and Endocrinology Associates of Stark County","Canton","Ohio","44718",{"type":45,"coordinates":149},[150,151],-81.37845,40.79895,{"lat":151,"lon":150},{"facility":154,"status":38,"city":155,"state":156,"zip":157,"country":42,"countryCode":43,"cosmosGeoPoint":158,"geoPoint":162,"contacts":25},"Elligo Health Research, Inc.","Austin","Texas","78704",{"type":45,"coordinates":159},[160,161],-97.74306,30.26715,{"lat":161,"lon":160},{"facility":164,"status":38,"city":165,"state":156,"zip":166,"country":42,"countryCode":43,"cosmosGeoPoint":167,"geoPoint":171,"contacts":25},"Zenos Clinical Research","Dallas","75230",{"type":45,"coordinates":168},[169,170],-96.80667,32.78306,{"lat":170,"lon":169},{"facility":173,"status":38,"city":174,"state":156,"zip":175,"country":42,"countryCode":43,"cosmosGeoPoint":176,"geoPoint":180,"contacts":25},"Synergy Groups Medical","Houston","77061",{"type":45,"coordinates":177},[178,179],-95.36327,29.76328,{"lat":179,"lon":178},{"facility":182,"status":38,"city":183,"state":156,"zip":184,"country":42,"countryCode":43,"cosmosGeoPoint":185,"geoPoint":189,"contacts":25},"Epic Clinical Research","Lewisville","75057",{"type":45,"coordinates":186},[187,188],-96.99417,33.04623,{"lat":188,"lon":187},{"facility":191,"status":38,"city":192,"state":156,"zip":193,"country":42,"countryCode":43,"cosmosGeoPoint":194,"geoPoint":198,"contacts":25},"Synergy Group Medical LLC","Missouri City","77459",{"type":45,"coordinates":195},[196,197],-95.53772,29.61857,{"lat":197,"lon":196},{"facility":200,"status":38,"city":201,"state":202,"zip":203,"country":42,"countryCode":43,"cosmosGeoPoint":204,"geoPoint":208,"contacts":25},"Manassas Clinical Research Center","Manassas","Virginia","20110",{"type":45,"coordinates":205},[206,207],-77.47527,38.75095,{"lat":207,"lon":206},{"type":210,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100631577","phase-2-phase-2-trial-of-icovamenib-in-participants-with-type-2-diabetes-who-are-not-achieving-glycemic-targets-100631577",false,"NCT07502495","Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets","A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets Despite Antihyperglycemic Medications","Key Inclusion Criteria:\n\n1. Males or females, age ≥18 years and ≤75 years\n2. Diagnosed with T2D\n3. Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable dose for at least 3 months prior to screening (if participants are taking metformin they must be on a minimum stable dose of ≥500 mg\u002Fday)\n4. Have HbA1c ≥7.5 and ≤10.5%\n5. Have a BMI ≤32 kg\u002Fm2\n6. Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating, must be willing to have additional pregnancy tests during the study, and must agree to the sex and contraception requirements.\n7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.\n\nKey Exclusion Criteria:\n\n1. Have type 1 diabetes mellitus or a secondary form of diabetes\n2. Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening\n3. Have positive GAD autoantibody result within 60 days prior to screening\n4. Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in the 6 months prior to screening or a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the investigator\n5. Have personal or family history (first-degree relative) of MEN1\n6. Use of GLP-1 RA, dual GIP\u002FGLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, \\[linagliptin, saxagliptin (these 2 are drugs within DPP-4i class)\\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening\n7. Have fasting triglyceride ≥500 mg\u002FdL\n8. Have an eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI Creatinine Equation at screening\n9. Have impaired liver function, defined as screening AST or ALT \\>1.2×ULN, and\u002For total bilirubin \\>ULN","ALL","18 Years","75 Years",{"count":222,"type":223},60,"ESTIMATED","INTERVENTIONAL",[226],"PHASE2","This is a Phase 2, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes who are not achieving glycemic targets despite antihyperglycemic medications.",[229],"Type 2 Diabetes",[229],"2026-08-05",{"date":233,"type":234},"2026-08-07","ACTUAL",{"date":236,"type":234},"2026-03-27",{"date":238,"type":223},"2027-09",{"name":5,"class":6},18]