[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ProGen. Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100645074","phase-2-phase-ii-study-of-switching-from-dulaglutide-to-pg-102mg12-in-type-2-diabetes-mellitus-100645074",false,"NCT07677891","Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus","A Randomized, Open-Label, Multicenter, Active-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Switching From Once-Weekly Dulaglutide to Once-Monthly PG-102(MG12) in Patients With Type 2 Diabetes Mellitus Receiving Stable Dulaglutide Therapy","Inclusion Criteria:\n\n1. Adults aged 19 to 75 years who provide informed consent.\n2. Diagnosed with type 2 diabetes for at least 6 months prior to screening.\n3. Stable on dulaglutide therapy (0.75 or 1.5 mg) for at least 12 weeks prior to screening, with dose and dosing interval maintained unchanged for 8 weeks prior to enrollment.\n4. HbA1c ≤ 7.5% at screening.\n5. If receiving oral anti-diabetic drugs (OADs), on a stable dose for at least 90 days prior to screening.\n6. BMI between 18.5 kg\u002Fm² and 30.0 kg\u002Fm².\n\nExclusion Criteria:\n\n1. Received any investigational medicinal product within 30 days prior to screening, or within 5 half-lives of the product if known (whichever is longer).\n2. History of hypersensitivity or severe adverse reactions to GLP-1RA, GLP-2 agents, the investigational product, or its components.\n3. Type 1 diabetes, special forms of diabetes (e.g., monogenic, post-pancreatectomy, steroid-induced), or history of DKA or HHS within 6 months prior to screening\n4. Severe gastrointestinal disorders affecting gastric emptying (e.g., gastroparesis, inflammatory bowel disease, gastric\u002Fduodenal ulcer, intestinal obstruction) or history of related surgery within the past year (e.g., sleeve gastrectomy, biliopancreatic diversion, jejunal\u002Fileal bypass).\n5. Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥110 mmHg) or severe hypertriglyceridemia (fasting triglycerides ≥500 mg\u002FdL) despite appropriate treatment. Patients may be enrolled if these conditions are adequately controlled during screening.\n6. NYHA Class III or IV heart failure; acute coronary syndrome (including MI), unstable angina, clinically significant CAD (CCS Class III-IV), CABG or emergent PCI, TIA, or cerebrovascular accident within the past 6 months. Patients may be enrolled if the event occurred \\>6 months ago and is considered resolved or stable.\n7. Active pancreatitis, history of recurrent or severe pancreatitis, or clinically significant gallbladder disease (e.g., cholecystitis, complications from gallstones) that is unresolved or at risk of recurrence.\n8. Active malignancy or history of malignancy treatment within the past 5 years. Exceptions: completely cured basal cell carcinoma, cervical carcinoma in situ, or other cured malignancies with no risk of recurrence as judged by the investigator.\n9. Personal or family history (first-degree relatives) of MEN type 2 or thyroid C-cell carcinoma (e.g., MTC). Exception: surgically cured simple thyroid nodules or benign non-C-cell thyroid conditions (e.g., thyroid adenoma, thyroid dysfunction).\n10. Active infectious disease (e.g., active TB, active viral hepatitis, HIV), or confirmed HBsAg-positive, HCV RNA-positive, or HIV infection, unless documented to be completely cured or currently inactive.\n11. History of hospitalization or emergency treatment for moderate or severe depressive disorder, bipolar disorder, or schizophrenia spectrum disorder within the past year. Exception: patients whose symptoms are currently stable under appropriate treatment and deemed safe to participate as assessed by the investigator.\n12. Therapeutic use of systemic corticosteroids for more than 14 days within 90 days prior to screening. Exception: short-term use (≤10 days) or non-absorbable topical, inhaled, intra-articular, or dermatological formulations.\n13. Diagnosis of or clinically suspected alcohol or drug abuse or dependence within 90 days prior to screening.\n14. AST or ALT \\>3× ULN or total bilirubin \\>2× ULN at screening. Exception: transient elevations confirmed to have normalized or to be stable on repeat testing.\n15. Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m² calculated by CKD-EPI equation.\n16. Moderate or severe hepatic impairment (Child-Pugh Grade B or above) or currently active drug-induced liver disease. Exception: history of drug-induced liver disease with complete recovery and stable liver function tests (AST, ALT, total bilirubin) within normal range.\n\n\"17. Severe or active diabetic complications, including:\n\n* Proliferative diabetic retinopathy currently receiving or requiring treatment (laser, vitrectomy, anti-VEGF, or steroid injections) within the past 3 months or planned treatment. (Non-proliferative or stable retinopathy is permitted with fundus examination at screening and regular follow-up.)\n* Diabetic nephropathy with overt proteinuria (≥300 mg\u002Fday) or eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m²\n* Severe diabetic neuropathy with uncontrolled pain despite optimized pharmacotherapy (e.g., antidepressants, gabapentinoids, analgesics) for ≥3 months, requiring continuous use of opioid or multiple combination analgesics.\n* Exception: patients with past complications that are currently stable and deemed safe to participate as assessed by the investigator.\" 18. Fertile women or fertile men (including those with fertile female partners) who do not agree to use dual contraception or abstinence from the time of written consent until 90 days after the last dose of investigational product. (Fertile women must have a negative serum pregnancy test during screening prior to study entry).\n\n  19\\. Currently pregnant or breastfeeding, or planning pregnancy during the study period or within 90 days after the last dose of investigational product.\n\n  20\\. Previous experience of persistent or recurrent vomiting or severe diarrhea requiring hospitalization, emergency treatment, or drug discontinuation following GLP-1 receptor agonist or GLP-2 analogue administration, or history of intestinal obstruction.\n\n  21\\. Patients who required dose reduction of dulaglutide due to intolerance and subsequently failed re-escalation to the previous dose. Exception: patients assessed by the investigator as currently maintaining stable treatment at the reduced dose.\n\n  22\\. History of or planned use of prohibited concomitant medications within 90 days prior to screening or during the study period. Exception: short-term use (≤14 days) for therapeutic necessity with no anticipated pharmacokinetic or pharmacodynamic interaction with the investigational product as judged by the investigator.\n\n  23\\. Use of insulin for diabetes management during the 1 year prior to screening. Exception: acute short-term use (≤14 days) during hospitalization or perioperative periods.\n\n  24\\. Patients deemed inappropriate for study participation by the investigator based on safety, compliance, or medical judgment (considering physical examination, baseline test results, medical history, etc.).\n\n  25\\. Self-reported body weight change of \\>5% within 12 weeks (90 days) prior to screening.\n\n  26\\. History of untreatable colorectal polyps. 27. Presence of factors that may affect IGF-1 measurement, such as growth hormone (GH) injections.","ALL","19 Years","75 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a randomized, open-label, multi-center, active-controlled Phase 2 clinical trial to evaluate the efficacy and safety of switching from once-weekly dulaglutide to PG-102(MG12) in patients with type 2 diabetes mellitus receiving stable dulaglutide therapy.\n\nThe treatment period is 32 weeks, with an additional 4-week safety follow-up. The primary endpoint is the change in HbA1c(%) from baseline at Week 32.",[27],"Type 2 Diabetes",[29,30,27,31],"PG-102","ProGen","GLP-1\u002FGLP-2","NOT_YET_RECRUITING","2026-06-24",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":21},"2026-10",{"date":40,"type":21},"2027-06",{"name":42,"class":43},"ProGen. Co., Ltd.","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":48,"conditions":55,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100607384","phase-2-phase-2-randomized-study-of-pg-102-vs-placebo-and-semaglutide-in-type-2-diabetes-mellitus-100607384","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.","18 Years",{"count":53,"type":21},80,[24],[56],"Type 2 Diabetes Mellitus (T2DM)","2025-09-15",{"date":59,"type":36},"2025-09-23",{"date":61,"type":21},"2026-01",{"date":63,"type":21},"2026-12",{"name":42,"class":43},1,""]