[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607384":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":31,"centralContacts":38,"locations":48,"responsibleParty":67,"collaborators":31,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":31,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":31,"studyType":82,"phases":83,"briefSummary":73,"conditions":85,"keywords":31,"overallStatus":87,"whyStopped":31,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"ProGen. Co., Ltd.","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"PG-102","EXPERIMENTAL","Participants receive PG-102 administered subcutaneously once weekly with dose titration.",[13],"Drug: PG-102",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive matching placebo administered subcutaneously once weekly.",[19],"Drug: Placebo",{"label":21,"type":22,"description":23,"interventionNames":24},"Semaglutide","ACTIVE_COMPARATOR","Participants receive open-label semaglutide administered subcutaneously once weekly, titrated to 1.0 mg.",[25],"Drug: Semaglutide",[27,32,35],{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","PG-102 is administered subcutaneously once weekly with a titration regimen.",[9],null,{"type":28,"name":15,"description":33,"armGroupLabels":34,"otherNames":31},"Placebo is administered subcutaneously once weekly.",[15],{"type":28,"name":21,"description":36,"armGroupLabels":37,"otherNames":31},"Open-label semaglutide is administered subcutaneously once weekly with titration regimen.",[21],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":31,"email":43},"Kyunghwa Son, Ph.D","CONTACT","+82-2-6098-2818","khson@progen.co.kr",{"name":45,"role":41,"phone":46,"phoneExt":31,"email":47},"Rosanna Sung","+82-2-6098-2849","bd@progen.co.kr",[49],{"facility":50,"status":31,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Emeritus Research","Camberwell","Victoria","3124","Australia","AU",{"type":57,"coordinates":58},"Point",[59,60],145.0694,-37.84205,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":65,"phoneExt":31,"email":66},"Rishi Shah","0395096166","rishishah@emeritusresearch.com",{"type":68,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100607384","phase-2-phase-2-randomized-study-of-pg-102-vs-placebo-and-semaglutide-in-type-2-diabetes-mellitus-100607384",false,"NCT07187856","Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus","A Phase 2 Randomised Controlled Study to Investigate the Efficacy and Safety of Subcutaneously Administered PG-102 for 24 Weeks Compared With Placebo and Open-Label Semaglutide in Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.\n* Adult males and females, 18 to 75 years of age (inclusive) on the day of signing the informed consent form (ICF).\n* Must have a diagnosis of T2DM for at least 6 months before screening based on the disease diagnostic criteria.\n* Must have an HbA1c value at screening of ≥7.0% and ≤10.0% (≥53 and ≤86 mmol\u002Fmol) and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000 mg\u002Fday and not more than the locally approved dose) for at least 3 months prior to screening.\n* Body mass index (BMI) ≥25 to \\\u003C40 kg\u002Fm2 at screening.\n\nExclusion Criteria:\n\n* Have a diagnosis of type 1 diabetes.\n* History of severe hypoglycaemia and\u002For hypoglycaemia unawareness within 6 months prior to screening.\n* Have active proliferative diabetic retinopathy or history of uncontrolled and potentially unstable diabetic retinopathy or maculopathy.\n* History of or current chronic pancreatitis, or acute pancreatitis within the past 6 months prior to screening.\n* Diagnosis of gastroparesis or history of bariatric surgery or a clinically significant gastric emptying abnormality, in the opinion of the investigator (or delegate).\n* Have known liver disease or obvious clinical signs or symptoms of liver disease, including acute or chronic hepatitis; or have any of the following at screening: ALT ≥ 3 × ULN, AST ≥ 3 × ULN, and total bilirubin ≥2 × ULN.\n* Concomitant therapy in addition to metformin therapy with another oral antihyperglycaemic medication (OAM) including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransport 2 inhibitors, alpha-glucosidase inhibitors, and meglitinides. Participants may be randomised if the additional OAM was discontinued at least 3 months prior to screening.\n* Have used insulin for diabetic control within the prior year; however, short-term use of insulin for acute conditions is allowed (≤14 days) in certain situations, such as during a hospitalisation or perioperatively.\n* Have had any exposure to GLP-1 analogues (including combination products) or other related compounds within the prior 3 months prior to screening, or any history ever of allergies to these medications. Patients who previously took GLP-1 analogues or related compounds and who discontinued those medications for intolerability or lack of efficacy will not be randomised.\n* Have been treated with prescription drugs that promote weight loss or similar body weight loss medications including over-the-counter medications within 3 months prior to screening.","ALL","18 Years","75 Years",{"count":80,"type":81},80,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2",[86],"Type 2 Diabetes Mellitus (T2DM)","NOT_YET_RECRUITING","2025-09-15",{"date":90,"type":91},"2025-09-23","ACTUAL",{"date":93,"type":81},"2026-01",{"date":95,"type":81},"2026-12",{"name":5,"class":6},1]