Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT06911203
Status:
RECRUITING
Last Update Posted:
2025-10-28
First Post:
2025-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BGM0504 in Participants With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098860', 'term': 'Tirzepatide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Week 0, Week 26', 'description': 'Change from baseline in body weight after 26 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in BMI', 'timeFrame': 'Week 18, Week 26', 'description': 'Change from baseline in BMI after 26 weeks of treatment'}, {'measure': 'Change From Baseline in Waist Circumference', 'timeFrame': 'Week 18, Week 26', 'description': 'Change from baseline in waist circumference after 26 weeks of treatment'}, {'measure': 'Change from Baseline in Systolic Blood Pressure (SBP)', 'timeFrame': 'Week 18, Week 26', 'description': 'Change from Baseline in SBP after 26 weeks of treatment'}, {'measure': 'Change from Baseline in Diastolic Blood Pressure (DBP)', 'timeFrame': 'Week 18, Week 26', 'description': 'Change from Baseline in DBP after 26 weeks of treatment'}, {'measure': 'Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)', 'timeFrame': 'Week 0, Week 26', 'description': 'Change from Baseline in IWQOL-Lite-CT after 26 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ● Able and willing to provide a written informed consent.\n\n * Male or female subjects, 18-65 years of age at the time of signing informed consent.\n * At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2;\n * Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.\n\nExclusion Criteria:\n\n* ●History of chronic or acute pancreatitis.\n\n * History of severe drug allergy or specific allergic disease or severe allergies.\n * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2).\n * History of malignant tumors \\[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\\].\n * Suspected or confirmed history of alcohol or drug abuse;\n * Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).\n * Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.\n * Pregnant or lactating woman.\n * Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT06911203', 'briefTitle': 'A Study of BGM0504 in Participants With Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'BrightGene Bio-Medical Technology Co., Ltd.'}, 'officialTitle': 'A Phase II, Randomized Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BGM0504 Compared to Tirzepatide in Adults Who Have Obesity', 'orgStudyIdInfo': {'id': 'BGM0504-II -WL-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BGM0504', 'description': 'Participants will receive BGM0504 subcutaneously(SC).', 'interventionNames': ['Drug: BGM0504']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tirzepatide', 'description': 'Paritcipants will receive tirzepatide SC.', 'interventionNames': ['Drug: Tirzepatide']}], 'interventions': [{'name': 'BGM0504', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['BGM0504']}, {'name': 'Tirzepatide', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Tirzepatide']}]}, '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', 'role': 'CONTACT', 'email': 'jiln@bjmu.edu.cn', 'phone': '+8613910978815'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BrightGene Bio-Medical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}