[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-diabetic-overweight-or-obese\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-diabetic-overweight-or-obese":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":21,"type":22},75,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Healthy","Non-diabetic Overweight or Obese","RECRUITING","2025-11-16",{"date":33,"type":34},"2025-11-20","ACTUAL",{"date":36,"type":34},"2025-10-21",{"date":38,"type":22},"2026-03-31",{"name":40,"class":41},"BrightGene Bio-Medical Technology Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":42},"100605712","phase-1-evaluate-the-pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-bgm0504-tablets-in-non-diabetic-overweight-or-obese-adult-subjects-100605712","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.","65 Years",{"count":52,"type":22},80,[25],"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.",[29],"2025-09-16",{"date":58,"type":34},"2025-09-19",{"date":60,"type":34},"2025-08-11",{"date":62,"type":22},"2026-05-13",{"name":40,"class":41}]