Evaluating BGM0504 Injection for Weight Management in Overweight or Obese Adults

A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BGM0504 Injection in Chinese Non-diabetes Participants with Overweight or Obese

This study is testing if a new injection called BGM0504 can help overweight or obese adults in China lose weight when combined with diet and exercise.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 620 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06704581 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled phase III clinical trial aims to assess the efficacy of BGM0504 injection in non-diabetic adults with obesity or overweight in China. Participants will receive weekly subcutaneous injections of BGM0504 at varying doses or a placebo for a total of 36 weeks, alongside diet, exercise, and behavioral interventions. The study will also evaluate the safety of BGM0504 over a 52-week period, focusing on weight management outcomes.

Who should consider this trial

Good fit: Ideal candidates are non-diabetic adults aged 18 to 65 with a BMI of 24.0 or higher and who have not achieved significant weight loss through diet and exercise alone.

Not a fit: Patients with diabetes or significant food allergies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for weight management in overweight or obese individuals.

How similar studies have performed: Other studies have shown promise with similar interventions, but this specific approach with BGM0504 is novel.

Eligibility criteria

Inclusion Criteria:

* A male or female aged 18 to 65 years inclusive at screening
* BMI≥28 kg/m², or 24.0≤BMI\<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesity or obstructive sleep apnea syndrome
* Weight change \< 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening
* Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study

Exclusion Criteria:

* Diabetes mellitus
* Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening
* Has been treated with GLP-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening
* Secondary disease or drug-induced obesity, including : elevated cortisol (e.g. Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.;
* History of pancreatitis
* Have the currently uncontrolled thyroid diseases with stable treatment dose and clinically significant abnormal results of thyroid function test occurred at screening
* Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history of other serious mental illness, or Any lifetime history of a suicide attempt

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ji,MD, chief physician, Peking University People's Hospital

Conditions Overweight or Obesity