[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605712":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":38,"centralContacts":47,"locations":53,"responsibleParty":68,"collaborators":38,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":38,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":38,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":38,"overallStatus":56,"whyStopped":38,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"BrightGene Bio-Medical Technology Co., Ltd.","INDUSTRY",[8,14,18,22,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","20 mg BGM0504 administered orally",[13],"Drug: BGM0504",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","40 mg BGM0504 administered orally",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","60 mg BGM0504 administered orally",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Placebo","PLACEBO_COMPARATOR","Placebo administered orally",[27],"Drug: Placebo",{"label":29,"type":10,"description":30,"interventionNames":31},"Cohort 4","80mg BGM0504 administered orally",[13],[33,39,41,43,45],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","BGM0504","Administered orally",[9],null,{"type":34,"name":35,"description":36,"armGroupLabels":40,"otherNames":38},[15],{"type":34,"name":35,"description":36,"armGroupLabels":42,"otherNames":38},[19],{"type":34,"name":23,"description":36,"armGroupLabels":44,"otherNames":38},[23],{"type":34,"name":35,"description":36,"armGroupLabels":46,"otherNames":38},[29],[48],{"name":49,"role":50,"phone":51,"phoneExt":38,"email":52},"MB ChB","CONTACT","240-673-0900","mohamed.al-ibrahim@pharmaron.com",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":38},"Pharmaron CPC, Inc","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-76.61219,39.29038,{"lat":66,"lon":65},{"type":69,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100605712","phase-1-evaluate-the-pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-bgm0504-tablets-in-non-diabetic-overweight-or-obese-adult-subjects-100605712",false,"NCT07166081","Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects","A Phase 1, Double-Blind, Randomized, Ascending-Dose, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets Orally Administered in Non-diabetic Overweight or Obese Adult Subjects","Inclusion Criteria:\n\n* Body mass index (BMI) meeting one of the following requirements:\n\n  1. Between ≥ 30.0 kg\u002Fm2 and ≤ 40.0 kg\u002Fm2 (obese); OR\n  2. Between ≥ 27.0 kg\u002Fm2 and \\\u003C 30.0 kg\u002Fm2 (overweight) with at least 1 of the following: One or more symptoms of prediabetes (impaired fasting plasma glucose and\u002For abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia\n* Have a stable body weight (\\\u003C5% self-reported change during the previous 12 weeks) before screening\n* 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\nExclusion Criteria:\n\n* Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (GLP-1) receptor agonists or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).\n* Have received GLP-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening.\n* Have received drugs that have an impact on body weight within 12 weeks before screening.\n* Known type I\u002FII diabetes.\n* History of acute or chronic pancreatitis or pancreatic injury.\n* History of drug abuse or alcoholism at screening.","ALL","18 Years","65 Years",{"count":81,"type":82},80,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","This is a Phase 1, single-center, randomized, placebo-controlled, ascending dose study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM0504 following daily oral administrations in non-diabetic overweight or obese adult subjects.",[88],"Non-diabetic Overweight or Obese","2025-09-16",{"date":91,"type":92},"2025-09-19","ACTUAL",{"date":94,"type":92},"2025-08-11",{"date":96,"type":82},"2026-05-13",{"name":5,"class":6},1]