[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605712":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":16,"studyPopulation":16,"armGroups":28,"interventions":53,"overallOfficials":16,"centralContacts":67,"locations":73,"responsibleParty":88,"collaborators":16,"id":90,"slug":16,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":16,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":16,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":16,"overallStatus":76,"whyStopped":16,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"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 tothe investigational product was assessed by the investigator","11 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 11",{"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",[29,35,39,43,49],{"label":30,"type":31,"description":32,"interventionNames":33},"Cohort 1","EXPERIMENTAL","20 mg BGM0504 administered orally",[34],"Drug: BGM0504",{"label":36,"type":31,"description":37,"interventionNames":38},"Cohort 2","40 mg BGM0504 administered orally",[34],{"label":40,"type":31,"description":41,"interventionNames":42},"Cohort 3","60 mg BGM0504 administered orally",[34],{"label":44,"type":45,"description":46,"interventionNames":47},"Placebo","PLACEBO_COMPARATOR","Placebo administered orally",[48],"Drug: Placebo",{"label":50,"type":31,"description":51,"interventionNames":52},"Cohort 4","80mg BGM0504 administered orally",[34],[54,59,61,63,65],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":16},"DRUG","BGM0504","Administered orally",[30],{"type":55,"name":56,"description":57,"armGroupLabels":60,"otherNames":16},[36],{"type":55,"name":56,"description":57,"armGroupLabels":62,"otherNames":16},[40],{"type":55,"name":44,"description":57,"armGroupLabels":64,"otherNames":16},[44],{"type":55,"name":56,"description":57,"armGroupLabels":66,"otherNames":16},[50],[68],{"name":69,"role":70,"phone":71,"phoneExt":16,"email":72},"MB ChB","CONTACT","240-673-0900","mohamed.al-ibrahim@pharmaron.com",[74],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":16},"Pharmaron CPC, Inc","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-76.61219,39.29038,{"lat":86,"lon":85},{"type":89,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","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":100,"type":101},80,"ESTIMATED","INTERVENTIONAL",[104],"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.",[107],"Non-diabetic Overweight or Obese","2025-09-16",{"date":110,"type":111},"2025-09-19","ACTUAL",{"date":113,"type":111},"2025-08-11",{"date":115,"type":101},"2026-05-13",{"name":5,"class":6},1]