[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610193":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":33,"locations":41,"responsibleParty":62,"collaborators":33,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":33,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":33,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":33,"overallStatus":44,"whyStopped":33,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"BrightGene Bio-Medical Technology Co., Ltd.","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"BGM1812 (Part A)","EXPERIMENTAL","Single ascending doses of BGM1812 administered subcutaneously (SC).",[13],"Drug: BGM1812",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (Part A)","PLACEBO_COMPARATOR","Placebo administered SC.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"BGM1812 (Part B)","Multiple ascending doses of BGM1812 administered SC.",[13],{"label":25,"type":16,"description":17,"interventionNames":26},"Placebo (Part B)",[19],[28,34,37,39],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","BGM1812","Administered SC.",[9],null,{"type":29,"name":35,"description":31,"armGroupLabels":36,"otherNames":33},"Placebo",[15],{"type":29,"name":30,"description":31,"armGroupLabels":38,"otherNames":33},[21],{"type":29,"name":35,"description":31,"armGroupLabels":40,"otherNames":33},[25],[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Pharmaron CPC, Inc","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-76.61219,39.29038,{"lat":54,"lon":53},[57],{"name":58,"role":59,"phone":60,"phoneExt":33,"email":61},"MD, MPH, FACP","CONTACT","410-706-8877","charmagne.beckett@pharmaron.com",{"type":63,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100610193","phase-1-evaluate-the-pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-bgm1812-injection-following-single-and-multiple-subcutaneous-administration-in-normal-to-overweight-or-obese-but-otherwise-healthy-men-and-women-100610193",false,"NCT07224399","Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women","A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women","Inclusion Criteria:\n\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* Body mass index (BMI) meeting one of the following requirements:\n\n  1. Between ≥ 30.0 kg\u002Fm2 and ≤ 40.0 kg\u002Fm2 (obese) (for Cohort 3-6); 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 (For Cohort 3- 6); OR\n  3. Between ≥ 23.0 kg\u002Fm2 and \\\u003C 27.0 kg\u002Fm2 healthy subjects (for Cohort 1 and Cohort 2)\n* Have a stable body weight (\\\u003C5% self-reported change during the previous 12 weeks) before screening\n\nExclusion Criteria:\n\n* Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to amylin agonist-based therapeutic agents or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).\n* Known type I\u002FII diabetes.\n* Has underwent gastric bariatric surgery in the past, or has had liposuction or fat removal within 1 year before screening, or plan to have bariatric surgery, liposuction or abdominal fat removal during the study period or other surgery that would obviously affect the body weight.\n* History of acute or chronic pancreatitis or pancreatic injury.\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":76,"type":77},60,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.",[83,84],"Healhty","Overweight or Obesity","2025-11-05",{"date":87,"type":88},"2025-11-06","ACTUAL",{"date":90,"type":88},"2025-10-09",{"date":92,"type":77},"2026-05-15",{"name":5,"class":6},1]