A Study to Evaluate Efficacy and Safety of BGM0504 Tablets in Overweight or Obese Participants Wi… (NCT07658560) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Evaluate Efficacy and Safety of BGM0504 Tablets in Overweight or Obese Participants Without Diabetes
China200 participantsStarted 2026-06-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;