A Study of BGM0504 Injection in Participants with Obesity or Overweight

Last updated: November 20, 2024
Sponsor: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Hypertriglyceridemia

Obesity

Treatment

5 mg BGM0504 injection

15 mg BGM0504 injection

10 mg BGM0504 injection administered subcutaneously (SC) once a week

Clinical Study ID

NCT06704581
BGM0504-Ⅲ-WL
  • Ages 18-65
  • All Genders

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

Eligibility Criteria

Inclusion

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 thefollowing comorbidities: i. Prediabetes (impaired fasting blood glucose and/orimpaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or oneor more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesityor 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 withchildbearing potential and their partners should use highly effective, medicallyaccepted contraception, will not have pregnancy and fertility plan, and refrain fromdonating ovum until one month after the end of the study

Exclusion

Exclusion Criteria:

  • Diabetes mellitus

  • Known to be allergic to 3 or more kinds of foods or medications, or allergic toGLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematousdermatitis, etc.) at screening

  • Has been treated with GLP-1 receptor agonists or similar drugs containing the sametarget, 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 dueto diet drug reduction/discontinuation, etc.;

  • History of pancreatitis

  • Have the currently uncontrolled thyroid diseases with stable treatment dose andclinically significant abnormal results of thyroid function test occurred atscreening

  • Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history ofother serious mental illness, or Any lifetime history of a suicide attempt

Study Design

Total Participants: 620
Treatment Group(s): 4
Primary Treatment: 5 mg BGM0504 injection
Phase: 3
Study Start date:
October 28, 2024
Estimated Completion Date:
March 27, 2026

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

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