A Study to Evaluate Efficacy and Safety of BGM0504 Tablets in Overweight or Obese Participants Without Diabetes

NCT07658560 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: BGM0504 tablets-Ⅱ-WL
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight or Obese Participants Without Diabetes

Outcome Measures

Primary Outcomes (1)

• Fasting body weight

  20 weeks

Secondary Outcomes (8)

• 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

Study Arms (5)

The dose1 group

EXPERIMENTAL

Administered p.o once daily，tablets

Drug: BGM0504 tablets

The dose2 group

EXPERIMENTAL

Administered p.o once daily,tablets

Drug: BGM0504 tablets

The dose3 group

EXPERIMENTAL

Administered p.o once daily,tablets

Drug: BGM0504 tablets

The dose4 group

EXPERIMENTAL

Administered p.o once daily,tablets

Drug: BGM0504 tablets

Placebo group

PLACEBO COMPARATOR

Administered p.o once daily,tablets

Drug: BGM0504 placebo

Interventions

BGM0504 tablets DRUG

Administered p.o once daily

The dose1 group

BGM0504 placebo DRUG

Administered p.o once daily

Placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ○ 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.

You may not qualify if:

• ● (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);

Sponsors & Collaborators

• BrightGene Bio-Medical Technology Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Linong Ji

CONTACT

(+86) 13910978815; jiln@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 22, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-03

Locations

CN (1)