Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT06716203
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 Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 207}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-08-25', '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': '2025-12-29', '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 is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise.\n\nThe main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.'}, '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 * 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 * Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.\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': 'NCT06716203', 'briefTitle': 'A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise', 'organization': {'class': 'INDUSTRY', 'fullName': 'BrightGene Bio-Medical Technology Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone', 'orgStudyIdInfo': {'id': 'BGM0504-Ⅲ -T2DM-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: 5 mg BGM0504', 'description': 'Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.', 'interventionNames': ['Drug: Drug: 5 mg BGM0504 Administered SC']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: 10 mg BGM0504', 'description': 'Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.', 'interventionNames': ['Drug: Drug: : 10 mg BGM0504 Administered SC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: Placebo', 'description': 'Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.', 'interventionNames': ['Drug: Drug: Placebo Administered SC']}], 'interventions': [{'name': 'Drug: 5 mg BGM0504 Administered SC', 'type': 'DRUG', 'description': 'Drug: BGM0504 Administered SC', 'armGroupLabels': ['Experimental: 5 mg BGM0504']}, {'name': 'Drug: : 10 mg BGM0504 Administered SC', 'type': 'DRUG', 'description': 'Drug: BGM0504 Administered SC', 'armGroupLabels': ['Experimental: 10 mg BGM0504']}, {'name': 'Drug: Placebo Administered SC', 'type': 'DRUG', 'description': 'Drug: Placebo Administered SC', 'armGroupLabels': ['Placebo Comparator: Placebo']}]}, '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': '+860139010978815'}], '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'}}}}