Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT07294235
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2025-12-07', 'studyFirstSubmitQcDate': '2025-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator', 'timeFrame': 'Baseline to Study Completion (Up to 6-9weeks)', 'description': 'Number of participants with AEs and SAEs will be assessed with reference to CTCAE V5.0'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812', 'timeFrame': 'Baseline to Study Completion (Up to 6-9weeks)', 'description': 'PK Cmax of BGM1812'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812', 'timeFrame': 'Baseline to Study Completion (Up to 6-9weeks)', 'description': 'PK:AUC of BGM1812'}, {'measure': 'Pharmacodynamics (PD): Fasting Blood Glucose of BGM1812', 'timeFrame': 'Baseline to Study Completion (Up to 6-9weeks)', 'description': 'PD: Changes in fasting blood glucosebefore and after administration, and differences in the amount of change among different dose groups'}, {'measure': 'PD:C-Peptide of BGM1812', 'timeFrame': 'Baseline to Study Completion (Up to 6-9weeks)', 'description': 'PD: Changes in C-peptide before and after administration, and differences in the amount of change among different dose groups'}, {'measure': 'PD: Insulin of BGM1812', 'timeFrame': 'Baseline to Study Completion (Up to 6-9weeks)', 'description': 'PD: Changes in insulin before and after administration, and differences in the amount of change among different dose groups'}, {'measure': 'PD: Body Weight of BGM1812', 'timeFrame': 'Baseline to Study Completion (Up to 6-9weeks)', 'description': 'PD: Changes in body weight before and after administration, and differences in the amount of change among different dose groupsPD: Changes in body weight before and after administration, and differences in the amount of change among different dose groups'}, {'measure': 'PD: Waist Circumference of BGM1812', 'timeFrame': 'Baseline to Study Completion (Up to 6-9weeks)', 'description': 'PD: Changes in waist circumference before and after administration, and differences in the amount of change among different dose groups'}, {'measure': 'Immunogenicity Endpoints', 'timeFrame': 'Baseline to Study Completion (Up to 6-9weeks)', 'description': 'Detect the anti-drug antibodies (ADA) of the study drug and their titers; if the ADA is positive, neutralizing antibodies (NAb) will be further detected.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight or Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female;\n* Healthy subjects , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI \\< 24 kg/m²（BMI = weight/height²）;\n* Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI \\< 28.0 kg/m²;\n* (Medical Inquiry) Have a stable body weight (\\<5% self-reported change during the previous 12 weeks) before screening.\n* Have no history of mental disorders, be able to communicate smoothly with Investigator, Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.\n* Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional medically acceptable form of contraception (female partner) for the duration of the study and for at least 3 months after dosing; must also agree to refrain from sperm donation for at least 3 months post dose.\n\nExclusion Criteria:\n\n* Those with a history of severe drug allergies (especially those with known or suspected allergies to related compounds of BGM1812), or complicated with severe specific allergic diseases/history, or with a severe allergic constitution.\n* Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.\n* 12-lead ECG shows ventricular heart rate \\< 50 beats/min or \\> 100 beats/min at screening/baseline, second or third degree atrioventricular block, long QT syndrome, QTcF\\> 470ms for women or \\> 450ms for men, pre-excitation syndrome or other significant arrhythmias.\n* Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening.\n* Participated in drug or medical device clinical trials and treated with Study Drug (excluding placebo) or medical device intervention within 12 weeks before screening.\n* Participants who have received any vaccine within 2 weeks prior to screening, or plan to receive a vaccine during the trial.\n* Female participants who are pregnant or lactating, or those with a positive pregnancy test result during the screening period.\n* Positive urine drug test or alcohol serum test result at screening or at baseline.\n* Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.'}, 'identificationModule': {'nctId': 'NCT07294235', 'briefTitle': 'A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'BrightGene Bio-Medical Technology Co., Ltd.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of BGM1812 in Healthy and Non-diabetic Overweight or Obese Chinese Participants', 'orgStudyIdInfo': {'id': 'BGM1812-CPK-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BGM1812(Part A)', 'description': 'Single ascending doses of BGM1812 administered subcutaneously (SC)', 'interventionNames': ['Drug: BGM1812']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Part A)', 'description': 'Placebo administered SC', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BGM1812 (Part B)', 'description': 'Multiple ascending doses of BGM1812 administered SC.', 'interventionNames': ['Drug: BGM1812']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Part B)', 'description': 'Placebo administered SC.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BGM1812', 'type': 'DRUG', 'description': 'AdministeredSC', 'armGroupLabels': ['BGM1812(Part A)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo (Part A)']}, {'name': 'BGM1812', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['BGM1812 (Part B)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo (Part B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianchang He', 'role': 'CONTACT', 'email': 'hejc@yn-cprc.com', 'phone': '13700680697'}], 'facility': 'The First Affiliated Hospital of Yunnan University of Chinese Medicine', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BrightGene Bio-Medical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BrightGene Pharmaceutical Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}