[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611391":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":16,"studyPopulation":16,"armGroups":28,"interventions":40,"overallOfficials":16,"centralContacts":47,"locations":53,"responsibleParty":73,"collaborators":16,"id":75,"slug":16,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":16,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":16,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":16,"overallStatus":56,"whyStopped":16,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"BrightGene Bio-Medical Technology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Number of treatment adverse events","The relationship of each adverse event to the investigational product was assessed by the investigator","8 weeks",[14,17],{"measure":15,"description":16,"timeFrame":12},"Pharmacokinetic endpoint: Concentration of BGM0504 in plasma",null,{"measure":18,"description":16,"timeFrame":12},"Change in fasting weight at week 8",{"allocation":20,"interventionModel":21,"interventionModelDescription":16,"primaryPurpose":22,"observationalModel":16,"timePerspective":16,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":16,"whoMasked":25},"DOUBLE",[26,27],"PARTICIPANT","INVESTIGATOR",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"BGM0504 tablets","EXPERIMENTAL","Oral administration once daily",[34],"Drug: BGM0504 tablets",{"label":36,"type":31,"description":37,"interventionNames":38},"Placebo tablets","Placebo Oral administration once daily",[39],"Drug: Placebo tablets",[41,45],{"type":42,"name":30,"description":43,"armGroupLabels":44,"otherNames":16},"DRUG","Administered p.o.",[30],{"type":42,"name":36,"description":43,"armGroupLabels":46,"otherNames":16},[36],[48],{"name":49,"role":50,"phone":51,"phoneExt":16,"email":52},"Jianchang He","CONTACT","13700680697","hejc@yn-cprc.com",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"The First Affiliated Hospital of Yunnan University of Chinese Medicine","RECRUITING","Kunming","Yunnan","650000","China","CN",{"type":63,"coordinates":64},"Point",[65,66],102.71833,25.03889,{"lat":66,"lon":65},[69],{"name":70,"role":50,"phone":71,"phoneExt":16,"email":72},"Rui Qian","13888185640","Qr740220@sina.com",{"type":74,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100611391",false,"NCT07239973","A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single\u002FMultiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.","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\u002Fm² ≤ BMI \\\u003C 28 kg\u002Fm²（BMI = weight\u002Fheight²）;\n* Obese individuals: BMI ≥ 28.0 kg\u002Fm², or overweight individuals: 24.0 kg\u002Fm² ≤ BMI \\\u003C 28.0 kg\u002Fm²;\n* (Medical Inquiry) Have a stable body weight (\\\u003C5% 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 the active ingredients and excipients of BGM0504 Tablets), or complicated with severe specific allergic diseases\u002Fhistory, 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* At the screening\u002Fbaseline period, any one of the laboratory test indicators meets the following criteria:\n\n  1. fasting serum glucose≥ 7.0mmol\u002FL, or post-prandial glucose (PPG)-2h≥ 11.1mmol\u002FL in oral glucose tolerance test (OGTT); (During screening, participants with fasting serum glucose ranging from 6.1 to 6.9mmol\u002FL shall undergo the OGTT.)\n  2. ALT, AST ≥ 2.5 times upper limit of normal (ULN) or total bilirubin ≥ 1.5 times upper limit of normal (ULN)\n  3. Glomerular filtration rate (eGFR) ≤ 80 mL\u002Fmin\u002F1.73 m2(using CKD-EPI formula) or positive urine protein 2+ or more.\n  4. Serum calcitonin level ≥ 35 ng\u002FL (pg\u002FmL);\n  5. Thyroid-stimulating hormone (TSH) \\> 6.0mIU\u002FL or \\\u003C 0.4mIU\u002FL;\n  6. Fasting triglycerides ≥ 5.64mmol\u002FL (500 mg\u002FdL);\n  7. Hemoglobin (Hgb) \\\u003C 100 g\u002FL (for females) or \\\u003C 110 g\u002FL (for males);\n* 12-lead ECG shows ventricular heart rate \\\u003C 50 beats\u002Fmin or \\> 100 beats\u002Fmin at screening\u002Fbaseline, 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.",true,"ALL","18 Years","55 Years",{"count":86,"type":87},75,"ESTIMATED","INTERVENTIONAL",[90],"PHASE1","A Randomized, Double-Blind, Placebo-Controlled, Single\u002FMultiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.",[93,94],"Healthy","Non-diabetic Overweight or Obese","2025-11-16",{"date":97,"type":98},"2025-11-20","ACTUAL",{"date":100,"type":98},"2025-10-21",{"date":102,"type":87},"2026-03-31",{"name":5,"class":6},1]