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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
Lead sponsor
Asset
BGM0504
Oral · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
200
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥28
Primary endpoint
•Fasting body weight
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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/GIP, Masudopeptide GLP-1/GCG, dual-target agonists; other drugs containing GLP-1 and other related weight loss targets in the experimental stage;
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;
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.;
4. 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.;
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);
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);
1. 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);
2. ALT or AST ≥ 2.5 times the upper limit of normal (ULN), or total bilirubin ≥ 1.5 times the ULN;
3. Glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m2 (CKD-EPI formula);
4. Serum calcitonin level ≥ 35 ng/L (pg/mL);
5. Thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L;
6. Fasting triglycerides ≥ 5.64 mmol/L (500 mg/dL);
7. Hemoglobin (HGB) < 100 g/L;
8. Serum amylase or serum lipase > 2.0 × ULN;
9. Positive hepatitis B surface antigen (HBsAg) and abnormal hepatitis B virus load (HBV-DNA) test value;
10. Positive hepatitis C antibody (HCV-Ab) and abnormal hepatitis C virus load (HCV-RNA) test value;
11. Positive immunodeficiency virus antibody (HIV-Ab) or positive syphilis spirochete antibody (TPAb).
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.;
2. (Interview/Examination) Previously or during screening diagnosed with type 1 or type 2 diabetes;
3. (Interview) Previously diagnosed with acute or chronic pancreatitis, or pancreatic injury;
4. (Interview) Previously diagnosed with thyroid C-cell carcinoma, MEN (multiple endocrine neoplasia) type 2A or 2B, or having a related family history;
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;
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;
7. (Interview) Confirmed to have a malignant tumor within 5 years before screening (cured carcinoma in situ can be excluded);
8. (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;
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;
10. (Interview) Had severe hypoglycemia or recurrent (≥ 2 times within 6 months) symptomatic hypoglycemia within 6 months before screening;
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;
12. (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;
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);
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
3 endpointsFasting body weight
Time frame:20 weeks
descriptive
Pharmacodynamics (PD)endpoint:waist circumference
Time frame:4、8、12、16、20 weeks
descriptive
PD endpoint:Body Mass Index(BMI)
Time frame:4、8、12、16、20 weeks
descriptive
Glycemic / diabetes
2 endpointsPD endpoint:fasting insulin
Time frame:4、8、12、16、20 weeks
descriptive
PD endpoint: fasting blood glucose
Time frame:4、8、12、16、20 weeks
descriptive
Cardiometabolic biomarkers
1 endpoint12-lead electrocardiogram (ECG), including heart rate, PR interval, QRS duration, QT interval, QTc interval, and QTcF
Time frame:Baseline
ratio, improvement
Safety / tolerability / PK
2 endpointsNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame:Baseline
event count, event
Number of Participants with Hypoglycemic Events
Time frame:Baseline
event count, event
Other clinical outcomes
1 endpointNumber of participants who are pregnant
Time frame:Baseline
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.