Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 5:14 PM
Study NCT ID:
NCT06920056
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2025-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BGM0504 in Overweight or Obese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Paracetamol', 'timeFrame': 'From Day1 to Day72', 'description': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Paracetamol'}, {'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Paracetamol', 'timeFrame': 'From Day1 to Day72', 'description': 'Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) of Paracetamol'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Metformin', 'timeFrame': 'From Day4 to Day76', 'description': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Metformin'}, {'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin', 'timeFrame': 'From Day4 to Day76', 'description': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin', 'timeFrame': 'From Day7 to Day84', 'description': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin'}, {'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin', 'timeFrame': 'From Day7 to Day84', 'description': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin'}], 'secondaryOutcomes': [{'measure': 'Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504', 'timeFrame': 'From Day14 to Day69', 'description': 'Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504'}, {'measure': 'Time to Maximum Concentration (Tmax) of Metformin and Warfarin', 'timeFrame': 'From Day1 to Day84', 'description': 'Time to Maximum Concentration (Tmax) of Metformin and Warfarin'}, {'measure': 'Terminal Half-life (t1/2) of Paracetamol', 'timeFrame': 'From Day1 to Day72', 'description': 'Terminal Half-life (t1/2) of Paracetamol'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight or Obese']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the influence of BGM0504 injection on gastric emptying and Pharmacokinetics of metformin and warfarin in overweight or obese participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: √ Have a body mass index (BMI) of greater than or equal to (≥)28 kilogram per square meter (kg/m²) or ≥24 kg/m2 and less than (\\<) 28 kg/m².\n\n√ Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.\n\nExclusion Criteria: √ 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': 'NCT06920056', 'briefTitle': 'A Study of BGM0504 in Overweight or Obese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'BrightGene Bio-Medical Technology Co., Ltd.'}, 'officialTitle': 'A Single Center, Open-label, Fixed Sequence Trial, Investigating the Influence of BGM0504 Injection on Gastric Emptying and Pharmacokinetics of Metformin and Warfarin in Overweight or Obese Participants', 'orgStudyIdInfo': {'id': 'BGM0504-DDI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paracetamol + Metformin + Warfarin +BGM0504', 'description': 'Participants receive Paracetamol on Day1 and Day70, Metformin on Day4 and Day73, Warfarin on Day7 and Day77.\n\nParticipants receive maintenance dose 10 mg (from D42 to Day 77) with dose escalation starting from 2.5 mg(on Day 14 and Day 21), 5 mg(on Day 28 and Day 35) and then 10 mg BGM0504 administered subcutaneously (SC) once weekly (QW).', 'interventionNames': ['Drug: Paracetamol', 'Drug: Metformin Hydrochloride', 'Drug: Warfarin', 'Drug: BGM0504']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'description': 'oral, postprandial', 'armGroupLabels': ['Paracetamol + Metformin + Warfarin +BGM0504']}, {'name': 'Metformin Hydrochloride', 'type': 'DRUG', 'description': 'Oral , Fasting', 'armGroupLabels': ['Paracetamol + Metformin + Warfarin +BGM0504']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Oral , Fasting', 'armGroupLabels': ['Paracetamol + Metformin + Warfarin +BGM0504']}, {'name': 'BGM0504', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Paracetamol + Metformin + Warfarin +BGM0504']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650100', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BrightGene Bio-Medical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}