Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT07187856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'PG-102 and Placebo are administered double-blind; the Semaglutide comparator arm is open-label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in HbA1c From Baseline at Week 24', 'timeFrame': '24 weeks', 'description': 'Mean absolute change in glycated hemoglobin (HbA1c) from baseline to Week 24, comparing PG-102 with placebo.'}], 'secondaryOutcomes': [{'measure': 'Absolute change in HbA1c from baseline to 12 weeks', 'timeFrame': '12 weeks', 'description': 'Mean absolute change in HbA1c from baseline to Week 12.'}, {'measure': 'Absolute Change in Body Weight From Baseline at Week 12 and 24', 'timeFrame': '12 and 24 weeks', 'description': 'Mean absolute change in body weight from baseline to Weeks 12 and 24.'}, {'measure': 'Percent Change in Body Weight From Baseline at Week 12 and 24', 'timeFrame': '12 and 24 weeks', 'description': 'Mean percent change in Body Weight from baseline to Week 12 and 24.'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) From Baseline at Week 12 and 24.', 'timeFrame': '12 and 24 weeks', 'description': 'Mean change in fasting plasma glucose (mg/dL) from baseline to Week 12 and 24.'}, {'measure': 'Change in 7-Point Self-Monitored Plasma Glucose (SMPG) Profile at Week 12 and 24.', 'timeFrame': '12 and 24 weeks', 'description': 'Mean change in the 7-point SMPG profile from baseline to Week 12 and 24.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': '24 weeks', 'description': 'Number and percentage of participants experiencing TEAEs, SAEs, and discontinuations due to adverse events.'}, {'measure': 'Incidence of Adverse Events of Special Interest (AESIs) - Gastrointestinal', 'timeFrame': '24 weeks', 'description': 'Incidence and severity of GI-related AESIs (e.g., nausea, vomiting, diarrhea).'}, {'measure': 'Incidence of anti-drug antibodies (ADA) to PG-102', 'timeFrame': '24 weeks', 'description': 'Number and percentage of participants developing anti-drug antibodies against PG-102.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': 'Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/mol) and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000 mg/day and not more than the locally approved dose) for at least 3 months prior to screening.\n* Body mass index (BMI) ≥25 to \\<40 kg/m2 at screening.\n\nExclusion Criteria:\n\n* Have a diagnosis of type 1 diabetes.\n* History of severe hypoglycaemia and/or 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.'}, 'identificationModule': {'nctId': 'NCT07187856', 'briefTitle': 'Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'ProGen. Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PG-102-P2-WW-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PG-102', 'description': 'Participants receive PG-102 administered subcutaneously once weekly with dose titration.', 'interventionNames': ['Drug: PG-102']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive matching placebo administered subcutaneously once weekly.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Semaglutide', 'description': 'Participants receive open-label semaglutide administered subcutaneously once weekly, titrated to 1.0 mg.', 'interventionNames': ['Drug: Semaglutide']}], 'interventions': [{'name': 'PG-102', 'type': 'DRUG', 'description': 'PG-102 is administered subcutaneously once weekly with a titration regimen.', 'armGroupLabels': ['PG-102']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is administered subcutaneously once weekly.', 'armGroupLabels': ['Placebo']}, {'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Open-label semaglutide is administered subcutaneously once weekly with titration regimen.', 'armGroupLabels': ['Semaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3124', 'city': 'Camberwell', 'state': 'Victoria', 'country': 'Australia', 'contacts': [{'name': 'Rishi Shah', 'role': 'CONTACT', 'email': 'rishishah@emeritusresearch.com', 'phone': '0395096166'}], 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}], 'centralContacts': [{'name': 'Kyunghwa Son, Ph.D', 'role': 'CONTACT', 'email': 'khson@progen.co.kr', 'phone': '+82-2-6098-2818'}, {'name': 'Rosanna Sung', 'role': 'CONTACT', 'email': 'bd@progen.co.kr', 'phone': '+82-2-6098-2849'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProGen. Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}