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.
○ 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.
● (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);
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.;