[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631578":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":201,"collaborators":25,"id":203,"slug":204,"hasResults":205,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":25,"eligibilityCriteria":209,"healthyVolunteers":205,"sex":210,"minAge":211,"maxAge":212,"enrollmentInfo":213,"targetDuration":25,"studyType":216,"phases":217,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"Biomea Fusion Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: icovamenib 100 mg","EXPERIMENTAL","Starting on Day 1, participants will receive icovamenib 100 mg QD in addition to their currently prescribed Ozempic (semaglutide injection)-based regimen. Treatment will last for 12 weeks.\n\nAt Week 12, participants will continue on a stable dose of their baseline Ozempic-based regimen. The total duration of the trial is approximately 56 weeks (including screening and follow-up)",[13],"Drug: icovamenib 100 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B: matching placebo 100 mg","PLACEBO_COMPARATOR","Starting on Day 1, participants will receive matching placebo QD in addition to their currently prescribed Ozempic (semaglutide injection)-based regimen. Treatment will last for 12 weeks.\n\nAt Week 12, participants will continue on a stable dose of their baseline Ozempic-based regimen. The total duration of the trial is approximately 56 weeks (including screening and follow-up).",[19],"Drug: Placebo",[21,26],{"type":22,"name":23,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","icovamenib 100 mg",[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","8442450490","clinicaltrials@biomeafusion.com",[36,50,60,69,78,87,97,106,115,125,135,145,155,164,173,182,191],{"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","Long Beach","90815",{"type":45,"coordinates":65},[66,67],-118.18923,33.76696,{"lat":67,"lon":66},{"facility":70,"status":38,"city":71,"state":53,"zip":72,"country":42,"countryCode":43,"cosmosGeoPoint":73,"geoPoint":77,"contacts":25},"Catalina Research Institute, LLC","Montclair","91763",{"type":45,"coordinates":74},[75,76],-117.68978,34.07751,{"lat":76,"lon":75},{"facility":79,"status":38,"city":80,"state":53,"zip":81,"country":42,"countryCode":43,"cosmosGeoPoint":82,"geoPoint":86,"contacts":25},"Paradigm Clinical Research Centers, LLC","San Diego","92108",{"type":45,"coordinates":83},[84,85],-117.16472,32.71571,{"lat":85,"lon":84},{"facility":88,"status":38,"city":89,"state":90,"zip":91,"country":42,"countryCode":43,"cosmosGeoPoint":92,"geoPoint":96,"contacts":25},"Southwest General Healthcare Center","Fort Myers","Florida","33907",{"type":45,"coordinates":93},[94,95],-81.84059,26.62168,{"lat":95,"lon":94},{"facility":98,"status":38,"city":99,"state":90,"zip":100,"country":42,"countryCode":43,"cosmosGeoPoint":101,"geoPoint":105,"contacts":25},"Panax Clinical Research","Miami Lakes","33014",{"type":45,"coordinates":102},[103,104],-80.30866,25.90871,{"lat":104,"lon":103},{"facility":107,"status":38,"city":108,"state":90,"zip":109,"country":42,"countryCode":43,"cosmosGeoPoint":110,"geoPoint":114,"contacts":25},"Flourish Research Orlando","Winter Park","32789",{"type":45,"coordinates":111},[112,113],-81.33924,28.6,{"lat":113,"lon":112},{"facility":116,"status":38,"city":117,"state":118,"zip":119,"country":42,"countryCode":43,"cosmosGeoPoint":120,"geoPoint":124,"contacts":25},"David Kavtaradze MD, Inc","Cordele","Georgia","31015",{"type":45,"coordinates":121},[122,123],-83.78239,31.96351,{"lat":123,"lon":122},{"facility":126,"status":38,"city":127,"state":128,"zip":129,"country":42,"countryCode":43,"cosmosGeoPoint":130,"geoPoint":134,"contacts":25},"Excel Clinical Research","Las Vegas","Nevada","89109",{"type":45,"coordinates":131},[132,133],-115.13722,36.17497,{"lat":133,"lon":132},{"facility":136,"status":38,"city":137,"state":138,"zip":139,"country":42,"countryCode":43,"cosmosGeoPoint":140,"geoPoint":144,"contacts":25},"Diabetes and Endocrinology Associates of Stark County","Canton","Ohio","44718",{"type":45,"coordinates":141},[142,143],-81.37845,40.79895,{"lat":143,"lon":142},{"facility":146,"status":38,"city":147,"state":148,"zip":149,"country":42,"countryCode":43,"cosmosGeoPoint":150,"geoPoint":154,"contacts":25},"Elligo Health Research, Inc.","Austin","Texas","78704",{"type":45,"coordinates":151},[152,153],-97.74306,30.26715,{"lat":153,"lon":152},{"facility":156,"status":38,"city":157,"state":148,"zip":158,"country":42,"countryCode":43,"cosmosGeoPoint":159,"geoPoint":163,"contacts":25},"Zenos Clinical Research","Dallas","75230",{"type":45,"coordinates":160},[161,162],-96.80667,32.78306,{"lat":162,"lon":161},{"facility":165,"status":38,"city":166,"state":148,"zip":167,"country":42,"countryCode":43,"cosmosGeoPoint":168,"geoPoint":172,"contacts":25},"Synergy Group Medical","Houston","77061",{"type":45,"coordinates":169},[170,171],-95.36327,29.76328,{"lat":171,"lon":170},{"facility":174,"status":38,"city":175,"state":148,"zip":176,"country":42,"countryCode":43,"cosmosGeoPoint":177,"geoPoint":181,"contacts":25},"Epic Clinical Research","Lewisville","75057",{"type":45,"coordinates":178},[179,180],-96.99417,33.04623,{"lat":180,"lon":179},{"facility":183,"status":38,"city":184,"state":148,"zip":185,"country":42,"countryCode":43,"cosmosGeoPoint":186,"geoPoint":190,"contacts":25},"Diabetes & Glandular Disease Clinic, P.A.","San Antonio","78229",{"type":45,"coordinates":187},[188,189],-98.49363,29.42412,{"lat":189,"lon":188},{"facility":192,"status":38,"city":193,"state":194,"zip":195,"country":42,"countryCode":43,"cosmosGeoPoint":196,"geoPoint":200,"contacts":25},"Burke Internal Medicine and Research","Burke","Virginia","22015",{"type":45,"coordinates":197},[198,199],-77.27165,38.79345,{"lat":199,"lon":198},{"type":202,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100631578","phase-2-phase-2-trial-of-icovamenib-in-participants-with-type-2-diabetes-mellitus-who-are-not-achieving-glycemic-targets-while-using-glp-1-based-therapy-100631578",false,"NCT07502508","Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy","Phase 2 Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Not Achieving Glycemic Targets Despite GLP-1-Based Therapy","Key Inclusion Criteria:\n\n1. Males or females, age ≥18 years and ≤70 years\n2. Have been diagnosed with T2D\n3. Taking Ozempic (semaglutide injection) and have been treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin and\u002For SGLT2 inhibitor) with a stable dose of all medications for at least 3 months prior to screening\n\n   * If participants are taking metformin, they must be on a minimum stable dose of ≥500 mg\u002Fday\n   * Participants must be on a minimum stable dose of Ozempic ≥0.5 mg\u002Fweek\n4. Have HbA1c ≥7.5 and ≤9.5%\n5. Have a BMI 25 to 40 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, 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 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\n4. Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma\n5. Use of GLP-1 RA other than Ozempic (semaglutide injection), dual GIP\u002FGLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening\n6. Have FPG ≥240 mg\u002FdL","ALL","18 Years","70 Years",{"count":214,"type":215},60,"ESTIMATED","INTERVENTIONAL",[218],"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 (T2D) not achieving glycemic targets despite Ozempic-based therapy.",[221],"Type 2 Diabetes",[221],"2026-06-11",{"date":225,"type":226},"2026-06-15","ACTUAL",{"date":228,"type":226},"2026-04-30",{"date":230,"type":215},"2027-07",{"name":5,"class":6},17]