[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607384":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":51,"interventions":70,"overallOfficials":40,"centralContacts":81,"locations":91,"responsibleParty":110,"collaborators":40,"id":112,"slug":40,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":40,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":40,"studyType":124,"phases":125,"briefSummary":115,"conditions":127,"keywords":40,"overallStatus":129,"whyStopped":40,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"ProGen. Co., Ltd.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Absolute change in HbA1c From Baseline at Week 24","Mean absolute change in glycated hemoglobin (HbA1c) from baseline to Week 24, comparing PG-102 with placebo.","24 weeks",[14,18,22,25,28,31,34,37],{"measure":15,"description":16,"timeFrame":17},"Absolute change in HbA1c from baseline to 12 weeks","Mean absolute change in HbA1c from baseline to Week 12.","12 weeks",{"measure":19,"description":20,"timeFrame":21},"Absolute Change in Body Weight From Baseline at Week 12 and 24","Mean absolute change in body weight from baseline to Weeks 12 and 24.","12 and 24 weeks",{"measure":23,"description":24,"timeFrame":21},"Percent Change in Body Weight From Baseline at Week 12 and 24","Mean percent change in Body Weight from baseline to Week 12 and 24.",{"measure":26,"description":27,"timeFrame":21},"Change in Fasting Plasma Glucose (FPG) From Baseline at Week 12 and 24.","Mean change in fasting plasma glucose (mg\u002FdL) from baseline to Week 12 and 24.",{"measure":29,"description":30,"timeFrame":21},"Change in 7-Point Self-Monitored Plasma Glucose (SMPG) Profile at Week 12 and 24.","Mean change in the 7-point SMPG profile from baseline to Week 12 and 24.",{"measure":32,"description":33,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","Number and percentage of participants experiencing TEAEs, SAEs, and discontinuations due to adverse events.",{"measure":35,"description":36,"timeFrame":12},"Incidence of Adverse Events of Special Interest (AESIs) - Gastrointestinal","Incidence and severity of GI-related AESIs (e.g., nausea, vomiting, diarrhea).",{"measure":38,"description":39,"timeFrame":12},"Incidence of anti-drug antibodies (ADA) to PG-102","Number and percentage of participants developing anti-drug antibodies against PG-102.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":46,"maskingDescription":47,"whoMasked":48},"DOUBLE","PG-102 and Placebo are administered double-blind; the Semaglutide comparator arm is open-label.",[49,50],"PARTICIPANT","INVESTIGATOR",[52,58,64],{"label":53,"type":54,"description":55,"interventionNames":56},"PG-102","EXPERIMENTAL","Participants receive PG-102 administered subcutaneously once weekly with dose titration.",[57],"Drug: PG-102",{"label":59,"type":60,"description":61,"interventionNames":62},"Placebo","PLACEBO_COMPARATOR","Participants receive matching placebo administered subcutaneously once weekly.",[63],"Drug: Placebo",{"label":65,"type":66,"description":67,"interventionNames":68},"Semaglutide","ACTIVE_COMPARATOR","Participants receive open-label semaglutide administered subcutaneously once weekly, titrated to 1.0 mg.",[69],"Drug: Semaglutide",[71,75,78],{"type":72,"name":53,"description":73,"armGroupLabels":74,"otherNames":40},"DRUG","PG-102 is administered subcutaneously once weekly with a titration regimen.",[53],{"type":72,"name":59,"description":76,"armGroupLabels":77,"otherNames":40},"Placebo is administered subcutaneously once weekly.",[59],{"type":72,"name":65,"description":79,"armGroupLabels":80,"otherNames":40},"Open-label semaglutide is administered subcutaneously once weekly with titration regimen.",[65],[82,87],{"name":83,"role":84,"phone":85,"phoneExt":40,"email":86},"Kyunghwa Son, Ph.D","CONTACT","+82-2-6098-2818","khson@progen.co.kr",{"name":88,"role":84,"phone":89,"phoneExt":40,"email":90},"Rosanna Sung","+82-2-6098-2849","bd@progen.co.kr",[92],{"facility":93,"status":40,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Emeritus Research","Camberwell","Victoria","3124","Australia","AU",{"type":100,"coordinates":101},"Point",[102,103],145.0694,-37.84205,{"lat":103,"lon":102},[106],{"name":107,"role":84,"phone":108,"phoneExt":40,"email":109},"Rishi Shah","0395096166","rishishah@emeritusresearch.com",{"type":111,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","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":122,"type":123},80,"ESTIMATED","INTERVENTIONAL",[126],"PHASE2",[128],"Type 2 Diabetes Mellitus (T2DM)","NOT_YET_RECRUITING","2025-09-15",{"date":132,"type":133},"2025-09-23","ACTUAL",{"date":135,"type":123},"2026-01",{"date":137,"type":123},"2026-12",{"name":5,"class":6},1]