[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603660":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":83,"collaborators":85,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":31,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":115,"whyStopped":31,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Myopharm Limited","OTHER",[8,14,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Metformin XR Monotherapy","ACTIVE_COMPARATOR","Participants receive metformin XR 1000-2000 mg\u002Fday together with matching placebo capsules and tablets corresponding to celecoxib and valsartan.",[13],"Drug: Metformin XR",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: TriGlytza Low Dose","EXPERIMENTAL","Participants receive metformin XR 1000-2000 mg\u002Fday together with celecoxib 100 mg once daily and valsartan 40 mg once daily.",[13,19,20],"Drug: Celecoxib","Drug: Valsartan",{"label":22,"type":16,"description":23,"interventionNames":24},"High-dose TriGlytza®-01","Participants receive metformin XR 1000-2000 mg\u002Fday together with celecoxib 200 mg once daily and valsartan 80 mg once daily.",[13,19,20],[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Metformin XR","Metformin extended-release tablets administered orally once daily according to protocol.",[9,15,22],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Celecoxib","Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment.",[15,22],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Valsartan","Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.",[15,22],[41],{"name":42,"affiliation":5,"role":43},"Charles Czank","STUDY_DIRECTOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Charles Czank, PhD MBA","CONTACT","+61 2 8527 2453","cczank@myopharm.com",{"name":51,"role":47,"phone":48,"phoneExt":31,"email":52},"Kurt Sales, PhD PGCM","ksales@myopharm.com",[54,66,75],{"facility":55,"status":31,"city":56,"state":57,"zip":31,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":31},"UniSC Clinical Trials","Maroochydore","Queensland","Australia","AU",{"type":61,"coordinates":62},"Point",[63,64],153.09953,-26.66008,{"lat":64,"lon":63},{"facility":67,"status":31,"city":68,"state":69,"zip":31,"country":58,"countryCode":59,"cosmosGeoPoint":70,"geoPoint":74,"contacts":31},"Momentum Sunshine","Melbourne","Victoria",{"type":61,"coordinates":71},[72,73],144.96332,-37.814,{"lat":73,"lon":72},{"facility":76,"status":31,"city":77,"state":31,"zip":31,"country":58,"countryCode":59,"cosmosGeoPoint":78,"geoPoint":82,"contacts":31},"Momentum Darlinghurst","Sydney",{"type":61,"coordinates":79},[80,81],151.20732,-33.86785,{"lat":81,"lon":80},{"type":84,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[86],{"name":87,"class":88},"Southern Star Research","INDUSTRY","100603660","phase-2-triglytza-01-versus-metformin-in-overweight-and-obese-adults-with-type-2-diabetes-and-inadequate-glycaemic-control-despite-metformin-therapy-100603660",false,"NCT07139405","TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy","A Double-Blind, Randomized, Active-Controlled Phase 2a Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TriGlytza®-01 in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy","RESILIENCE-2a","Inclusion Criteria Adults aged 18 to 70 years. Confirmed diagnosis of Type 2 diabetes mellitus. Inadequate glycaemic control while receiving a stable dose of metformin.\n\nInclusion Criteria:\n\n* Adults aged 18 to 70 years.\n* Confirmed diagnosis of Type 2 diabetes mellitus.\n* Inadequate glycaemic control while receiving a stable dose of metformin.\n* HbA1c within the protocol-defined screening range.\n* Body mass index (BMI) 25 to 40 kg\u002Fm².\n* Adequate renal function.\n* Able and willing to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus or history of diabetic ketoacidosis.\n* Use of prohibited glucose-lowering medications before screening.\n* Clinically significant renal, hepatic, gastrointestinal, cardiovascular, or other medical conditions that could interfere with study participation or safety.\n* Recent major cardiovascular event or unstable cardiovascular disease.\n* Previous bariatric surgery or recent treatment with anti-obesity medication.\n* Active infection or other uncontrolled medical condition.\n* Pregnant or breastfeeding, or unwilling to comply with protocol-required contraception.\n* Any condition that, in the investigator's opinion, would make participation unsuitable or compromise the study.","ALL","18 Years","70 Years",{"count":101,"type":102},48,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","This Phase 2a, randomized, double-blind, active-controlled study will evaluate the safety, tolerability, and preliminary efficacy of TriGlytza®-01 compared with metformin in adults with Type 2 diabetes inadequately controlled despite metformin therapy. Participants will be randomized to one of three treatment groups and treated for 16 weeks. Safety, glycaemic control, body weight, and other metabolic outcomes will be assessed",[108],"Type 2 Diabetes (T2DM)",[110,111,112,113,37,114],"Type 2 Diabetes","Diabetes","Metformin","Myopharm","Celecoxcib","NOT_YET_RECRUITING","2026-07-05",{"date":118,"type":119},"2026-07-08","ACTUAL",{"date":121,"type":102},"2026-09-01",{"date":123,"type":102},"2027-12-30",{"name":5,"class":6},3]