Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT06716216
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2024-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of BGM0504 in Participants with Type 2 Diabetes
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': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 537}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-11-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Week 0 to Week 32', 'description': 'Change from baseline in HbA1c after 32 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Week 0 to Week 52', 'description': 'Change from baseline in body weight after 52 weeks of treatment.'}, {'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Week 0 to Week 52', 'description': 'Change from baseline in HbA1c after 52weeks of treatment.'}, {'measure': 'Percentage of Participants With HbA1c Target Value of <7%', 'timeFrame': 'Week 0 to Week 52', 'description': 'Percentage of Participants With HbA1c Target Value of \\<7% after 52weeks of treatment.'}, {'measure': 'Percentage of Participants With HbA1c Target Value of <5.7%', 'timeFrame': 'Week 0 to Week 52', 'description': 'Percentage of Participants With HbA1c Target Value of \\<5.7%after 52weeks of treatment.'}, {'measure': 'Change From Baseline in Fasting Serum Glucose', 'timeFrame': 'Week 0 to Week 52', 'description': 'Change from baseline in FPG after 52 weeks of treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': 'This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ■ Have been diagnosed with type 2 diabetes mellitus (T2DM);\n\n * Metformin is used in screening : 1) After used stable-dose metformin (≥1500 mg/day) or maximum tolerated (\\< 1500mg but≥1000mg daily) for 8 weeks before screening； 2)Metformin treatment dose \\<1500mg/day at Screening and have not reached the maximum tolerated dose ；3) Metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period.\n * Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;\n * Be of stable weight (± 5%) for at least 3 months before screening;\n * Have HbA1c between ≥7.5% and ≤11.0%；\n\nExclusion Criteria:\n\n* ■ Previous diagnosis of type 1 diabetes, special type diabetes;\n\n * There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).\n * Have had chronic or acute pancreatitis any time prior to study entry;\n * Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;\n * Mentally incapacitated or speech-impaired;\n * Suspected or confirmed history of alcohol or drug abuse;\n * Pregnant or lactating woman;\n * The investigator considers that there are any other conditions that make it inappropriate to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06716216', 'briefTitle': 'A Study of BGM0504 in Participants with Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'BrightGene Bio-Medical Technology Co., Ltd.'}, 'officialTitle': 'A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly As Add-on Therapy to Metformin And/or Sulfonylureas in Patients with Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BGM0504-Ⅲ -T2DM-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.', 'description': 'Drug: BGM0504 Administered SC', 'interventionNames': ['Drug: Drug: 5 mg BGM0504 Administered SC']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.', 'description': 'Drug: BGM0504 Administered SC', 'interventionNames': ['Drug: Drug:10 mg BGM0504 Administered SC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week', 'description': 'Drug: Semaglutide Administered SC', 'interventionNames': ['Drug: Drug: Semaglutide Administered SC']}], 'interventions': [{'name': 'Drug: 5 mg BGM0504 Administered SC', 'type': 'DRUG', 'description': 'Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.', 'armGroupLabels': ['Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.']}, {'name': 'Drug:10 mg BGM0504 Administered SC', 'type': 'DRUG', 'description': 'Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.', 'armGroupLabels': ['Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.']}, {'name': 'Drug: Semaglutide Administered SC', 'type': 'DRUG', 'description': 'Active Comparator: 1 mg Semaglutide\n\n1 mg semaglutide administered SC once a week', 'armGroupLabels': ['Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linong Ji', 'role': 'CONTACT', 'email': 'jiln@bjmu.edu.cn', 'phone': '+8613910978815'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': "Linong Ji,MD, chief physician, Peking University People's Hospital", 'role': 'CONTACT', 'email': 'jiln@bjmu.edu.cn', 'phone': '+86 13910978815'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BrightGene Bio-Medical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}