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Recruiting NCT06704581

A Study of BGM0504 Injection in Participants with Obesity or Overweight

Phase III Interventional Overweight or Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 5 mg BGM0504 injection, 10 mg BGM0504 injection administered subcutaneously (SC) once a week, 15 mg BGM0504 injection, BGM0504 placebo.
Who it may be relevant to
Registry conditions: Overweight or Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 5 mg BGM0504 injection
    5mg BGM0504 injection administered subcutaneously (SC) once a week.
  • Drug 10 mg BGM0504 injection administered subcutaneously (SC) once a week
    10mg BGM0504 injection administered subcutaneously (SC) once a week.
  • Drug 15 mg BGM0504 injection
    15mg BGM0504 injection administered subcutaneously (SC) once a week.
  • Drug BGM0504 placebo
    BGM0504 placebo administered SC once a week.

Primary outcome measures

  • Percent Change from Baseline in Body Weight [Time frame: Baseline,Week 36]
  • Percentage of Participants Who Achieve≥5% Body Weight Reduction [Time frame: Baseline,Week 36]
Secondary outcome measures (10)
  • Percent Change From Baseline in Body Weight [Time frame: Baseline, Week 52]
  • Change From Baseline in Body Weight [Time frame: Baseline, Week36 and 52]
  • Percentage of Participants Who Achieve≥5% Body Weight Reduction [Time frame: Baseline, Week 36 and 52]
  • Percentage of Participants Who Achieve≥10% Body Weight Reduction [Time frame: Baseline, Week 36 and 52]
  • Percentage of Participants Who Achieve≥15%Body Weight Reduction [Time frame: Baseline, Week 36 and 52]
  • Percentage of Participants Who Achieve≥20% Body Weight Reduction [Time frame: Baseline, Week 36 and 52]
  • Change From Baseline in Waist Circumference [Time frame: Baseline, Week 36 and 52]
  • Change From Baseline in Body Mass Index (BMI) [Time frame: Baseline, Week 36 and 52]
  • Change From Baseline in Fasting Glucose [Time frame: Baseline, Week 36 and 52]
  • Change From Baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline, Week 36 and 52]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hospital — Beijing

Identifiers

NCT: NCT06704581 · BGM0504-Ⅲ-WL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗