NCT07658560尚未招募2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Fasting body weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •○ 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.
- •(Medical history and examination) Obese participants: BMI ≥ 28.0 kg/m²; or overweight participants: 24.0 kg/m² ≤ BMI < 28.0 kg/m² and have at least one of the following conditions: i. Pre-diabetes (impaired fasting glucose and/or 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.
- •(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.
- •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 < 160 mmHg and sitDBP < 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.
- •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.
- •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.
排除标准
- •● (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/condition (such as asthma, urticaria, eczema, etc.) or with a severe allergic constitution (two or more food or drug allergies);
- •(Medical Inquiry) Before screening, they used any of the following drugs or treatments:
- •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/GIP, Masudopeptide GLP-1/GCG, dual-target agonists; other drugs containing GLP-1 and other related weight loss targets in the experimental stage;
- •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;
- •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.;
- •Within the previous 12 weeks, used drugs for weight control, such as: sibutramine, phenbutyram, phenylpropanolamine, chlorbiménoxide, fenfluramine, aniracetam, chlorcardinol, fenfluramine/trospirenone combination, naltrexone/anhydrotoban combination, orlistat, etc.;
- •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);
- •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);
- •(Examination) At the screening/baseline stage, any one of the following laboratory test indicators meets the following criteria:
- •Glycated hemoglobin (HbA1c) ≥6.5%, fasting blood glucose ≥7.0 mmol/L, or 2-hour blood glucose of oral glucose tolerance test (OGTT) ≥11.1 mmol/L (during screening, participants with fasting blood glucose ranging from 6.1 to 6.9 mmol/L need to undergo the OGTT test);
- •ALT or AST ≥ 2.5 times the upper limit of normal (ULN), or total bilirubin ≥ 1.5 times the ULN;
- •Glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m2 (CKD-EPI formula);
- •Serum calcitonin level ≥ 35 ng/L (pg/mL);
- •Thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L;
- •Fasting triglycerides ≥ 5.64 mmol/L (500 mg/dL);
- •Hemoglobin (HGB) < 100 g/L;
- •Serum amylase or serum lipase > 2.0 × ULN;
- •Positive hepatitis B surface antigen (HBsAg) and abnormal hepatitis B virus load (HBV-DNA) test value;
- •Positive hepatitis C antibody (HCV-Ab) and abnormal hepatitis C virus load (HCV-RNA) test value;
- •Positive immunodeficiency virus antibody (HIV-Ab) or positive syphilis spirochete antibody (TPAb).
- •During the screening/baseline 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;
- •There is a history or evidence of any of the following diseases:
- •(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.;
- •(Interview/Examination) Previously or during screening diagnosed with type 1 or type 2 diabetes;
- •(Interview) Previously diagnosed with acute or chronic pancreatitis, or pancreatic injury;
- •(Interview) Previously diagnosed with thyroid C-cell carcinoma, MEN (multiple endocrine neoplasia) type 2A or 2B, or having a related family history;
- •(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;
- •(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;
- •(Interview) Confirmed to have a malignant tumor within 5 years before screening (cured carcinoma in situ can be excluded);
- •(Interview/Examination) 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;
- •(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;
- •(Interview) Had severe hypoglycemia or recurrent (≥ 2 times within 6 months) symptomatic hypoglycemia within 6 months before screening;
- •(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;
- •(Interview/Examination) 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;
- •(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);
- •(Interview) Suspected or confirmed to have a history of drug abuse or alcohol abuse during screening;
- •(Interview/Query) 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;
- •(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;
- •(Interview/Examination) Pregnant or lactating female trial participants;
- •Other trial participants determined by the researcher to be unsuitable to participate in this study or who withdrew from the trial for personal reasons.
研究组 & 干预措施
The dose1 group
Experimental
Administered p.o once daily，tablets
干预措施: BGM0504 tablets (Drug)
The dose2 group
Experimental
Administered p.o once daily,tablets
干预措施: BGM0504 tablets (Drug)
The dose3 group
Experimental
Administered p.o once daily,tablets
干预措施: BGM0504 tablets (Drug)
The dose4 group
Experimental
Administered p.o once daily,tablets
干预措施: BGM0504 tablets (Drug)
Placebo group
Placebo Comparator
Administered p.o once daily,tablets
干预措施: BGM0504 placebo (Drug)
结局指标
主要结局
Fasting body weight
时间窗: 20 weeks
次要结局
- 12-lead electrocardiogram (ECG), including heart rate, PR interval, QRS duration, QT interval, QTc interval, and QTcF(Baseline)
- Number of participants who are pregnant(Baseline)
- Number of Participants with Hypoglycemic Events(Baseline)
- Pharmacodynamics (PD）endpoint：waist circumference(4、8、12、16、20 weeks)
- PD endpoint：Body Mass Index（BMI）(4、8、12、16、20 weeks)
- PD endpoint：fasting insulin(4、8、12、16、20 weeks)
- PD endpoint： fasting blood glucose(4、8、12、16、20 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Baseline)
研究者
研究点 (1)
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