[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BrightGene Bio-Medical Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":251},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,65,85,106,128,148,172,192,212,233],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100641761","phase-2-a-study-to-evaluate-efficacy-and-safety-of-bgm0504-tablets-in-overweight-or-obese-participants-without-diabetes-100641761",false,"NCT07658560","A Study to Evaluate Efficacy and Safety of BGM0504 Tablets in Overweight or Obese Participants Without Diabetes","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of BGM0504 Tablets in Overweight or Obese Participants Without Diabetes","Inclusion Criteria:\n\n* ○ Participants must be Chinese, non-diabetic, overweight or obese individuals aged 18 to 55 years (inclusive), as determined by the time of signing the informed consent form. Both men and women are eligible.\n\n  * (Medical history and examination) Obese participants: BMI ≥ 28.0 kg\u002Fm²; or overweight participants: 24.0 kg\u002Fm² ≤ BMI \\\u003C 28.0 kg\u002Fm² and have at least one of the following conditions: i. Pre-diabetes (impaired fasting glucose and\u002For impaired glucose tolerance), hypertension, non-alcoholic fatty liver disease, or dyslipidemia; ii. Weight-bearing joint pain; iii. Obesity-induced breathing difficulties or obstructive sleep apnea syndrome.\n  * (Medical history) Participants must have undergone at least 12 weeks of diet and exercise control before screening, with a weight change of less than 5.0% (self-reported), and be willing to continue with the same diet and exercise control during the trial period.\n  * For participants with hypertension at screening, the sitting systolic blood pressure (sitSBP) and sitting diastolic blood pressure (sitDBP) at the time of enrollment must be sitSBP \\\u003C 160 mmHg and sitDBP \\\u003C 100 mmHg. They must be on stable treatment with two or fewer antihypertensive drugs (monotherapy, combination of two drugs, or fixed-dose combination) for at least two weeks or have been on diet and exercise control without antihypertensive drugs for at least four weeks.\n  * Participants must be willing to take effective contraceptive measures from the time of signing the informed consent form until one month after the last dose and have no plans to donate sperm or eggs.\n  * Participants must commit to having no history of mental disorders, be able to communicate smoothly with the researchers, fully understand the trial content, process, and potential adverse reactions, strictly follow the research procedures, and voluntarily participate by signing the informed consent form.\n\nExclusion Criteria:\n\n* ● (Medical Inquiry) Individuals with a history of severe drug allergy (especially known or suspected allergy to the components and excipients of BGM0504 tablets) or with a severe specific allergic reaction disease\u002Fcondition (such as asthma, urticaria, eczema, etc.) or with a severe allergic constitution (two or more food or drug allergies);\n\n  * (Medical Inquiry) Before screening, they used any of the following drugs or treatments:\n\n    1. Within the previous 12 weeks, used GLP-1 receptor agonists or similar drugs targeting the same target, including semaglutide, liraglutide, dulaglutide, exenatide, lisaglutide, benralizumab, lorcetanib, enoglutide, etc. of the GLP-1RA class; telprotide, etc. of the GLP-1\u002FGIP, Masudopeptide GLP-1\u002FGCG, dual-target agonists; other drugs containing GLP-1 and other related weight loss targets in the experimental stage;\n    2. Within the previous 12 weeks, used systemic glucocorticoids, including short-acting ones such as hydrocortisone, cortisone; medium-acting ones such as prednisone, prednisolone, methylprednisolone, triamcinolone; long-acting ones such as dexamethasone, betamethasone;\n    3. Within the previous 12 weeks, used tricyclic antidepressants, psychiatric drugs or sedatives that significantly affect body weight, including imipramine, amitriptyline, mirtazapine, paroxetine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, lithium salts, etc.;\n    4. Within the previous 12 weeks, used drugs for weight control, such as: sibutramine, phenbutyram, phenylpropanolamine, chlorbiménoxide, fenfluramine, aniracetam, chlorcardinol, fenfluramine\u002Ftrospirenone combination, naltrexone\u002Fanhydrotoban combination, orlistat, etc.;\n    5. Within the previous 12 weeks, used other drugs or supplements for weight loss purposes, or meal replacement products, including other prescription drugs, over-the-counter drugs, Chinese herbal medicines, supplements, meal replacement products (whether for weight loss purposes is determined by the prescription or product instructions);\n    6. Non-pharmaceutical treatments such as acupuncture and physical therapy for the purpose of weight loss were received within 12 weeks before screening (whether it is for the purpose of weight loss is subject to the medical record or prescription);\n  * (Examination) At the screening\u002Fbaseline stage, any one of the following laboratory test indicators meets the following criteria:\n\n    1. Glycated hemoglobin (HbA1c) ≥6.5%, fasting blood glucose ≥7.0 mmol\u002FL, or 2-hour blood glucose of oral glucose tolerance test (OGTT) ≥11.1 mmol\u002FL (during screening, participants with fasting blood glucose ranging from 6.1 to 6.9 mmol\u002FL need to undergo the OGTT test);\n    2. ALT or AST ≥ 2.5 times the upper limit of normal (ULN), or total bilirubin ≥ 1.5 times the ULN;\n    3. Glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin\u002F1.73m2 (CKD-EPI formula);\n    4. Serum calcitonin level ≥ 35 ng\u002FL (pg\u002FmL);\n    5. Thyroid stimulating hormone (TSH) \\> 6.0 mIU\u002FL or \\\u003C 0.4 mIU\u002FL;\n    6. Fasting triglycerides ≥ 5.64 mmol\u002FL (500 mg\u002FdL);\n    7. Hemoglobin (HGB) \\\u003C 100 g\u002FL;\n    8. Serum amylase or serum lipase \\> 2.0 × ULN;\n    9. Positive hepatitis B surface antigen (HBsAg) and abnormal hepatitis B virus load (HBV-DNA) test value;\n    10. Positive hepatitis C antibody (HCV-Ab) and abnormal hepatitis C virus load (HCV-RNA) test value;\n    11. Positive immunodeficiency virus antibody (HIV-Ab) or positive syphilis spirochete antibody (TPAb).\n  * During the screening\u002Fbaseline assessment, 12-lead electrocardiogram showed a heart rate of less than 50 beats per minute or more than 100 beats per minute, second or third degree atrioventricular block, long QT syndrome or female QTcF greater than 470 ms or male greater than 450 ms, or other electrocardiogram abnormalities judged by the researchers as requiring drug intervention;\n  * There is a history or evidence of any of the following diseases:\n\n    1. (Interview) It belongs to a secondary disease or drug-induced obesity, including: elevated cortisol hormone (such as Cushing's syndrome), obesity caused by damage to the pituitary and hypothalamus, obesity caused by reducing or discontinuing weight loss drugs, etc.;\n    2. (Interview\u002FExamination) Previously or during screening diagnosed with type 1 or type 2 diabetes;\n    3. (Interview) Previously diagnosed with acute or chronic pancreatitis, or pancreatic injury;\n    4. (Interview) Previously diagnosed with thyroid C-cell carcinoma, MEN (multiple endocrine neoplasia) type 2A or 2B, or having a related family history;\n    5. (Interview) Previously undergone gastric weight loss surgery, or within 1 year before screening underwent liposuction or fat removal surgery, or planned to undergo weight loss surgery, liposuction or abdominal fat removal surgery during the study period, which significantly affects body weight;\n    6. (Interview) Previously had a moderate or severe depression history, or during screening the PHQ-9 (depression screening scale) questionnaire was ≥ 15 points, or had a history of other serious mental illness, or had suicidal tendencies or suicidal behavior;\n    7. (Interview) Confirmed to have a malignant tumor within 5 years before screening (cured carcinoma in situ can be excluded);\n    8. (Interview\u002FExamination) Had any of the following heart diseases within 6 months before screening: such as decompensated heart function insufficiency (NYHA classification of grade III or IV); unstable angina pectoris, myocardial infarction, history of coronary artery bypass grafting or coronary stent implantation;\n    9. (Interview) Had hemorrhagic stroke or ischemic stroke within 6 months before screening, and the researcher evaluated that it was not suitable to participate in this clinical trial;\n    10. (Interview) Had severe hypoglycemia or recurrent (≥ 2 times within 6 months) symptomatic hypoglycemia within 6 months before screening;\n    11. (Examination) Had thyroid dysfunction that could not be controlled with stable drug doses, or the thyroid function test results had clinically significant abnormalities and required initiation of treatment during screening;\n    12. (Interview\u002FExamination) Abdominal B-ultrasound at screening indicated the presence of gallbladder stones, clinical symptoms or treatment-requiring gallbladder polyps, or other clinical symptoms of gallbladder diseases;\n    13. (Interview) Had significant gastric emptying abnormalities at screening (such as severe gastroparesis or gastric outlet obstruction), or currently had severe gastrointestinal diseases affecting drug absorption, distribution, metabolism, and excretion, or had undergone gastrointestinal surgery affecting drug absorption (such as gastrointestinal anastomosis or intestinal resection);\n  * (Interview) Suspected or confirmed to have a history of drug abuse or alcohol abuse during screening;\n  * (Interview\u002FQuery) Participants who had participated in drug or medical device clinical trials within 3 months before screening and received the study drug (placebo excluded) or medical device intervention;\n  * (Interview) Participants who had donated blood or lost blood ≥ 400 mL (except for blood loss during menstruation) within 3 months before screening or planned to donate blood during the trial or after the trial;\n  * (Interview\u002FExamination) Pregnant or lactating female trial participants;\n  * Other trial participants determined by the researcher to be unsuitable to participate in this study or who withdrew from the trial for personal reasons.","ALL","18 Years","55 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To evaluate the efficacy of BGM0504 tablets compared with placebo in reducing body weight in overweight or obese participants without diabetes after 20 weeks of treatment.",[27],"Overweight or Obese Participants Without Diabetes","NOT_YET_RECRUITING","2026-06-15",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":21},"2026-06-30",{"date":36,"type":21},"2027-02-28",{"name":38,"class":39},"BrightGene Bio-Medical Technology Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100636506","phase-1-a-study-of-bgm0504-tablets-in-healthy-chinese-subjects-100636506","NCT07566572","A Study of BGM0504 Tablets in Healthy Chinese Subjects","A Randomized, Open-label, Multiple-dose Phase I Clinical Study to Evaluate the Effect of a High-fat Meal and Different Dosing Conditions on the Pharmacokinetics of BGM0504 Tablets in Healthy Chinese Participants.","Inclusion Criteria:\n\n* ○ Between the ages of 18 and 55 years (inclusive) at the time of screening, both male and female;\n\n  * weight ≥ 50 kg, and body mass index (BMI): 24.0 kg\u002Fm² ≤ BMI \\\u003C 30 kg\u002Fm²（BMI = weight\u002Fheight²）;\n  * (Medical Inquiry) Have a stable body weight (\\\u003C5% self-reported change during the previous 12 weeks) before screening.\n  * Participants should be willing to take effective contraceptive measures from the date of signing the informed consent form until 3 months after the last administration, and have no plans for sperm or egg donation.\n  * Participants who were determined to be generally healthy by the investigator based on their past medical history, physical examination, vital signs, laboratory tests and electrocardiogram examinations.\n\nExclusion Criteria:\n\n* ● (Medical Inquiry) Individuals with a history of severe drug allergies (especially known or suspected allergies to the components and excipients of BGM0504 tablets) or those with severe specific allergic diseases\u002Fdiseases history or severe allergic constitution;\n\n  * (Medical Inquiry) Individuals who have previously suffered from or currently have major diseases in the nervous system, cardiovascular system, digestive system, respiratory system, urinary system, endocrine system, blood system or immune system, and are judged by the investigator to be unsuitable to participate in this trial;\n  * (Examination) Any laboratory test results judged by the investigator as abnormal and of clinical significance;\n  * (Medical Inquiry\u002FExamination) Individuals who previously had obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), affected gastric emptying (such as pyloric stenosis), or had undergone any gastrointestinal surgery (except for intestinal polyp resection and appendectomy), or had acute diarrhea, constipation within the 7 days before randomization; Diarrhea is defined as watery stools and\u002For daily defecation ≥ 3 times. Constipation is defined as the inability to achieve at least one defecation per day;\n  * (Medical Inquiry\u002FExamination) During the screening, individuals with acute cholecystitis, chronic cholecystitis; or those with symptomatic or treatable gallstones at the time of screening; or those with symptomatic or treatable gallbladder polyps at the time of screening;\n  * (Medical Inquiry) Individuals previously diagnosed with thyroid C-cell carcinoma, MEN (Multiple Endocrine Adenoma Disease) type 2A or 2B, or with a related family history;\n  * (Medical Inquiry) Individuals previously diagnosed with acute or chronic pancreatitis, or pancreatic injury;\n  * (Medical Inquiry\u002FQuery) Individuals who used any prescription drugs or over-the-counter drugs (including chemical drugs, vitamin drugs, herbal drugs, etc.) within 2 weeks before screening;\n  * (Examination) Individuals with any positive results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody during the screening period;\n  * (Examination) At the screening\u002Fbaseline, 12-lead electrocardiogram shows a heart rate of \\\u003C 50 beats per minute or \\> 100 beats per minute, second or third degree atrioventricular conduction block, long QT syndrome or for women QTcF \\> 470 ms or for men \\> 450 ms or other electrocardiogram abnormalities judged by the investigator as requiring drug intervention;\n  * (Medical Inquiry) Individuals with a history of fainting during blood transfusion or needle phobia;\n  * (Medical Inquiry) Individuals who have taken drugs or had drug abuse history within 6 months before screening;\n  * (Medical Inquiry) Individuals who smoked more than 10 cigarettes per day on average (including nicotine replacement products) within 3 months before screening, or who could not prohibit smoking throughout the trial stay;\n  * (Medical Inquiry) Individuals who frequently drank alcohol within the 3 months before screening, that is, with an average daily alcohol intake of more than 2 units (1 unit = 17.7 mL ethanol, that is, 1 unit = 357 mL alcohol for 5% beer or 43 mL alcohol for 40% liquor or 147 mL alcohol for 12% wine) or who could not abstain from alcohol throughout the trial stay;\n  * (Medical Inquiry) Individuals who donated blood or lost more than 400 mL of blood within 3 months before screening or plan to donate blood during or after the trial;\n  * (Medical Inquiry\u002FQuery) Individuals who participated in drug or medical device clinical trials and received trial drugs (except for placebo) or medical device interventions within 3 months before screening;\n  * (Medical Inquiry) Individuals who received any vaccine or plan to receive a vaccine during screening;\n  * (Medical Inquiry\u002FExamination) Female participants who are pregnant or lactating, or those with positive pregnancy test results during the screening period;\n  * (Examination) Individuals with positive urine drug or alcohol breath screening at the baseline period;\n  * Individuals determined by the investigator to be unsuitable to participate in this study or who withdrew from the study for personal reasons",true,{"count":50,"type":21},144,[52],"PHASE1","A randomized, open-label, multiple-dose study to evaluate the effects of high-fat meals and different administration conditions (including water intake and fasting time) on the pharmacokinetics of BGM0504 tablets at a dose of 20mg in healthy Chinese participants and to assess its safety and tolerability.",[55],"Chinese Healthy Volunteers","RECRUITING","2026-04-27",{"date":59,"type":32},"2026-05-05",{"date":61,"type":32},"2026-03-26",{"date":63,"type":21},"2026-09-30",{"name":38,"class":39},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":40},"100622383","phase-1-bioequivalence-study-of-bgm0504-injection-100622383","NCT07382908","Bioequivalence Study of BGM0504 Injection","A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight\u002FObese Participants","Inclusion Criteria:\n\n* Age 18-55 years (inclusive).\n* Male weight ≥50 kg, female weight ≥45 kg, and overweight (24.0 ≤ BMI \\\u003C 28.0 kg\u002Fm²) or obese (BMI ≥ 28.0 kg\u002Fm²).\n* From signing the ICF until 3 months after dosing, no pregnancy plan and willing to use effective contraception to avoid pregnancy or causing partner pregnancy, and no plan for sperm\u002Fegg donation.\n* The participant fully understands the trial purpose, nature, methods, and potential adverse reactions, can complete the trial according to the protocol, has good living habits, can maintain good communication with the investigator, and voluntarily signs the ICF.\n\nExclusion Criteria:\n\n* History of severe allergies or severe specific allergic diseases\u002Fhistory (asthma, urticaria, eczematous dermatitis, etc.) or allergic constitution (allergic to two or more foods or drugs), known or suspected allergy to any excipient of BGM0504 Injection.\n* Previous diagnosis of type 1 or type 2 diabetes, or clinically significant abnormal HbA1c at screening.\n* Family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome.\n* History of acute\u002Fchronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.\n* Past or screening findings of digestive system diseases that may increase participant risk.\n* Positive for HBsAg, HCV antibody, syphilis antibody, or HIV antibody at screening.\n* Participation in any drug or medical device clinical trial and receiving investigational product\u002Fdevice intervention within 3 months prior to screening.\n* Consumption or plan to consume specific foods (including pitaya, mango, grapefruit, pomelo or their juices, high-purine foods like animal organs, seafood, chocolate) or beverages containing caffeine\u002Falcohol within 48 hours before dosing; or unwilling to stop consuming these during the in-house period.\n* Pregnant or breastfeeding women, or positive pregnancy test at screening.\n* Any other condition considered by the investigator as unsuitable for participation or participant withdrawal due to personal reasons..",{"count":50,"type":21},[52],"This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).",[76],"Overweight\u002FObesity","2026-01-26",{"date":79,"type":32},"2026-02-03",{"date":81,"type":32},"2025-12-23",{"date":83,"type":21},"2026-02-12",{"name":38,"class":39},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":40},"100615563","phase-1-a-study-of-bgm1812-injection-in-healthy-and-non-diabetic-overweight-or-obese-chinese-participants-100615563","NCT07294235","A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single\u002FMultiple-dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of BGM1812 in Healthy and Non-diabetic Overweight or Obese Chinese Participants","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 24 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 related compounds of BGM1812), 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* 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.",{"count":93,"type":21},60,[52],"The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.",[97],"Overweight or Obesity","2025-12-07",{"date":100,"type":32},"2025-12-19",{"date":102,"type":32},"2025-12-05",{"date":104,"type":21},"2026-03-02",{"name":38,"class":39},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":40},"100611391","phase-1-a-study-of-bgm0504-tablets-in-healthy-and-non-diabetic-overweight-or-obese-chinese-subjects-100611391","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.",{"count":114,"type":21},75,[52],"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.",[118,119],"Healthy","Non-diabetic Overweight or Obese","2025-11-16",{"date":122,"type":32},"2025-11-20",{"date":124,"type":32},"2025-10-21",{"date":126,"type":21},"2026-03-31",{"name":38,"class":39},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":40},"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","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.",{"count":93,"type":21},[52],"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.",[139,97],"Healhty","2025-11-05",{"date":142,"type":32},"2025-11-06",{"date":144,"type":32},"2025-10-09",{"date":146,"type":21},"2026-05-15",{"name":38,"class":39},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100597899","phase-3-a-study-of-bgm0504-in-participants-with-type-2-diabetes-in-indonesia-100597899","NCT07064486","A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia","A Phase 3, Randomized, Open Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes","Inclusion Criteria:\n\n* ○ Have been diagnosed with type 2 diabetes mellitus (T2DM);\n\n  * Be on stable treatment with unchanged dose of metformin ≥1500 mg\u002Fday or \\\u003C1500 mg\u002Fday but ≥1000 mg\u002Fday (the maximum tolerated dose) for at least 8 weeks prior to screening\n  * Have a BMI ≥23 kilograms per meter squared (kg\u002Fm²) at screening;\n  * Be of stable weight (± 5%) for at least 3 months before screening;\n  * Have HbA1c between ≥7.5% and ≤11.0% at screening\n\nExclusion Criteria:\n\n* ○ Previous diagnosis of type 1 diabetes, special type diabetes;\n\n  * Have suffered the malignancy within the past 5 years (except cured basal cell carcinoma of the skin, cervical carcinoma in situ), or being evaluated for an underlying malignancy;\n  * Have the acute or chronic pancreatitis;\n  * Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist or metformin, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening;\n  * Have a serious mental illness or speech impediment and be unable to fully understand the study;\n  * Suspected or confirmed history of alcohol or drug abuse;\n  * Have had a history of ≥2 severe hypoglycemic episodes in the past 1 year;\n  * Other conditions that may impact the assessment of investigational products, as determined by the Investigator.","75 Years",{"count":157,"type":21},477,[159],"PHASE3","This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes",[162],"Type 2 Diabetes (T2DM)","2025-10-27",{"date":165,"type":32},"2025-10-28",{"date":167,"type":32},"2025-07-04",{"date":169,"type":21},"2026-07-31",{"name":38,"class":39},4,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":40},"100586117","phase-2-a-study-of-bgm0504-in-participants-with-obesity-100586117","NCT06911203","A Study of BGM0504 in Participants With Obesity","A Phase II, Randomized Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BGM0504 Compared to Tirzepatide in Adults Who Have Obesity","Inclusion Criteria:\n\n* ● Able and willing to provide a written informed consent.\n\n  * Male or female subjects, 18-65 years of age at the time of signing informed consent.\n  * At screening visit, 35.0 ﹤BMI﹤ 45.0 kg\u002Fm2;\n  * Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.\n\nExclusion Criteria:\n\n* ●History of chronic or acute pancreatitis.\n\n  * History of severe drug allergy or specific allergic disease or severe allergies.\n  * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2).\n  * History of malignant tumors \\[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\\].\n  * Suspected or confirmed history of alcohol or drug abuse;\n  * Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).\n  * Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.\n  * Pregnant or lactating woman.\n  * Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.","65 Years",{"count":181,"type":21},90,[24],"To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.",[185],"Obesity",{"date":165,"type":32},{"date":188,"type":32},"2025-04-03",{"date":190,"type":21},"2026-01-11",{"name":38,"class":39},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":179,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":40},"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.",{"count":200,"type":21},80,[52],"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.",[119],"2025-09-16",{"date":206,"type":32},"2025-09-19",{"date":208,"type":32},"2025-08-11",{"date":210,"type":21},"2026-05-13",{"name":38,"class":39},{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":40},"100571128","phase-3-a-study-of-bgm0504-in-participants-with-type-2-diabetes-100571128","NCT06716216","A Study of BGM0504 in Participants with Type 2 Diabetes","A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly As Add-on Therapy to Metformin And\u002For Sulfonylureas in Patients with Type 2 Diabetes","Inclusion Criteria:\n\n* ■ Have been diagnosed with type 2 diabetes mellitus (T2DM);\n\n  * Metformin is used in screening : 1) After used stable-dose metformin (≥1500 mg\u002Fday) or maximum tolerated (\\\u003C 1500mg but≥1000mg daily) for 8 weeks before screening； 2)Metformin treatment dose \\\u003C1500mg\u002Fday at Screening and have not reached the maximum tolerated dose ；3) Metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period.\n  * Have a BMI ≥23 kilograms per meter squared (kg\u002Fm²) at screening;\n  * Be of stable weight (± 5%) for at least 3 months before screening;\n  * Have HbA1c between ≥7.5% and ≤11.0%；\n\nExclusion Criteria:\n\n* ■ Previous diagnosis of type 1 diabetes, special type diabetes;\n\n  * There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).\n  * Have had chronic or acute pancreatitis any time prior to study entry;\n  * Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;\n  * Mentally incapacitated or speech-impaired;\n  * Suspected or confirmed history of alcohol or drug abuse;\n  * Pregnant or lactating woman;\n  * The investigator considers that there are any other conditions that make it inappropriate to participate in this study.",{"count":220,"type":21},537,[159],"This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and\u002For sulfonylureas in patients with type 2 diabetes",[224],"Type 2 Diabetes Mellitus (T2DM)","2025-02-06",{"date":227,"type":32},"2025-02-07",{"date":229,"type":32},"2024-11-29",{"date":231,"type":21},"2026-11-14",{"name":38,"class":39},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":40},"100571127","phase-3-a-study-of-bgm0504-in-poorly-controlled-type-2-diabetes-patients-only-through-diet-and-exercise-100571127","NCT06716203","A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise","A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone","Inclusion Criteria:\n\n* ☑ Have been diagnosed with type 2 diabetes mellitus (T2DM);\n\n  * Have a BMI ≥23 kilograms per meter squared (kg\u002Fm²) at screening;\n  * Be of stable weight (± 5%) for at least 3 months before screening;\n  * Have HbA1c between ≥7.5% and ≤11.0%；\n  * Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL\u002FL.\n\nExclusion Criteria:\n\n* ■ Previous diagnosis of type 1 diabetes, special type diabetes ;\n\n  * There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).\n  * Have had chronic or acute pancreatitis any time prior to study entry;\n  * Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;\n  * Mentally incapacitated or speech-impaired;\n  * Suspected or confirmed history of alcohol or drug abuse;\n  * Pregnant or lactating woman;\n  * The investigator considers that there are any other conditions that make it inappropriate to participate in this study.",{"count":241,"type":21},207,[159],"This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise.\n\nThe main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.",[224],{"date":227,"type":32},{"date":247,"type":32},"2024-12-02",{"date":249,"type":21},"2026-08-25",{"name":38,"class":39},""]