Overweight or Obese Participants Without DiabetesPhase 2NCT07658560
A Study to Evaluate Efficacy and Safety of BGM0504 Tablets in Overweight or Obese Participants Without Diabetes
A Phase 2 study testing BGM0504 tablets in people with Overweight or Obese Participants Without Diabetes, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Overweight or Obese Participants Without Diabetes
- What is being tested?
- BGM0504 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2026to 28 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ○ 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.
Who cannot join
- ● (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.;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: 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
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.
- Being tested
- BGM0504 tablets, BGM0504 placebo
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGM0504 tabletsDrug
Administered p.o once daily
BGM0504 tabletsDrug
Administered p.o once daily
BGM0504 tabletsDrug
Administered p.o once daily
BGM0504 tabletsDrug
Administered p.o once daily
BGM0504 placeboDrug
Administered p.o once daily
| Study group | Role | What they receive |
|---|---|---|
| The dose1 group | Experimental | Administered p.o once daily，tablets Receives: Drug: BGM0504 tablets |
| The dose2 group | Experimental | Administered p.o once daily,tablets Receives: Drug: BGM0504 tablets |
| The dose3 group | Experimental | Administered p.o once daily,tablets Receives: Drug: BGM0504 tablets |
| The dose4 group | Experimental | Administered p.o once daily,tablets Receives: Drug: BGM0504 tablets |
| Placebo group | Placebo comparator | Administered p.o once daily,tablets Receives: Drug: BGM0504 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting body weight
Measured: 20 weeks
Secondary outcomes (8)
Pharmacodynamics (PD）endpoint：waist circumference
Measured: 4、8、12、16、20 weeks
PD endpoint：Body Mass Index（BMI）
Measured: 4、8、12、16、20 weeks
PD endpoint：fasting insulin
Measured: 4、8、12、16、20 weeks
PD endpoint： fasting blood glucose
Measured: 4、8、12、16、20 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Baseline
12-lead electrocardiogram (ECG), including heart rate, PR interval, QRS duration, QT interval, QTc interval, and QTcF
Measured: Baseline
Number of participants who are pregnant
Measured: Baseline
Number of Participants with Hypoglycemic Events
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start29 Jun 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or Obese Participants Without DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658560
- Sponsor's protocol ID
- BGM0504 tablets-Ⅱ-WL
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07658560
- Acronym / sponsor ID
- BGM0504 tablets-Ⅱ-WL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| The dose1 group | Experimental | Drug: BGM0504 tabletsAdministered p.o once daily，tablets |
| The dose2 group | Experimental | Drug: BGM0504 tabletsAdministered p.o once daily,tablets |
| The dose3 group | Experimental | Drug: BGM0504 tabletsAdministered p.o once daily,tablets |
| The dose4 group | Experimental | Drug: BGM0504 tabletsAdministered p.o once daily,tablets |
| Placebo group | Placebo comparator | Drug: BGM0504 placeboAdministered p.o once daily,tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ○ 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.
Key exclusion criteria (40 listed)
- ● (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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGM0504 tabletsAdministered p.o once daily | Drug | The dose1 group |
| BGM0504 tabletsAdministered p.o once daily | Drug | The dose2 group |
| BGM0504 tabletsAdministered p.o once daily | Drug | The dose3 group |
| BGM0504 tabletsAdministered p.o once daily | Drug | The dose4 group |
| BGM0504 placeboAdministered p.o once daily | Drug | Placebo group |
Primary outcome
Fasting body weight
Time frame: 20 weeks
8 secondary outcomes
Pharmacodynamics (PD）endpoint：waist circumference
Time frame: 4、8、12、16、20 weeks
PD endpoint：Body Mass Index（BMI）
Time frame: 4、8、12、16、20 weeks
PD endpoint：fasting insulin
Time frame: 4、8、12、16、20 weeks
PD endpoint： fasting blood glucose
Time frame: 4、8、12、16、20 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Baseline
12-lead electrocardiogram (ECG), including heart rate, PR interval, QRS duration, QT interval, QTc interval, and QTcF
Time frame: Baseline
Number of participants who are pregnant
Time frame: Baseline
Number of Participants with Hypoglycemic Events
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGM0504 tablets in people with Overweight or Obese Participants Without Diabetes, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linong Ji ((+86) 13910978815, jiln@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting body weight (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.