[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611391":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":27,"locations":33,"responsibleParty":53,"collaborators":24,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":24,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":24,"overallStatus":36,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"BrightGene Bio-Medical Technology Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BGM0504 tablets","EXPERIMENTAL","Oral administration once daily",[13],"Drug: BGM0504 tablets",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo tablets","Placebo Oral administration once daily",[18],"Drug: Placebo tablets",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Administered p.o.",[9],null,{"type":21,"name":15,"description":22,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},"Jianchang He","CONTACT","13700680697","hejc@yn-cprc.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The First Affiliated Hospital of Yunnan University of Chinese Medicine","RECRUITING","Kunming","Yunnan","650000","China","CN",{"type":43,"coordinates":44},"Point",[45,46],102.71833,25.03889,{"lat":46,"lon":45},[49],{"name":50,"role":30,"phone":51,"phoneExt":24,"email":52},"Rui Qian","13888185640","Qr740220@sina.com",{"type":54,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100611391","phase-1-a-study-of-bgm0504-tablets-in-healthy-and-non-diabetic-overweight-or-obese-chinese-subjects-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":67,"type":68},75,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74,75],"Healthy","Non-diabetic Overweight or Obese","2025-11-16",{"date":78,"type":79},"2025-11-20","ACTUAL",{"date":81,"type":79},"2025-10-21",{"date":83,"type":68},"2026-03-31",{"name":5,"class":6},1]