Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate Efficacy and Safety of BGM0504 Injection in Chinese Adults with Overweight or Obesity
Led by BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd. · Updated on 2024-11-26
620
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effects of BGM0504 injection in Chinese adults who are overweight or obese but do not have diabetes. This phase III randomized, double-blind, placebo-controlled study aims to measure how BGM0504 works alongside diet, exercise, and behavioral changes for weight management over 36 weeks, and also assess its safety and effectiveness over 52 weeks. Participants will receive weekly subcutaneous injections of either 5 mg, 10 mg, or 15 mg of BGM0504, or a placebo injection, while continuing diet and exercise interventions. The study includes a 36-week treatment period focused on weight change and a longer 52-week period to evaluate sustained effects and safety. During the study, participants will have regular assessments including body weight, waist circumference, body mass index (BMI), fasting glucose, and hemoglobin A1c (HbA1c) measurements at baseline, 36 weeks, and 52 weeks. Researchers will monitor changes in these outcomes, particularly the percentage of participants achieving at least 5% weight loss by week 36. Safety and tolerability will also be tracked throughout participation, which lasts up to 52 weeks.
CONDITIONS
Brief Title
A Study of BGM0504 Injection in Participants with Obesity or Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years at screening
- Body mass index (BMI) ≥28 kg/m², or BMI between 24.0 and 28.0 kg/m² with at least one of the following: prediabetes, hypertension, nonalcoholic fatty liver disease, joint pain with weight bearing, dyspnea caused by obesity, or obstructive sleep apnea syndrome
- Weight change less than 5.0% after diet and exercise control for at least 12 weeks before screening
- Female participants not pregnant or lactating and using effective contraception if of childbearing potential, with no pregnancy or fertility plans during the study and for one month after
You will not qualify if you...
- Diabetes mellitus
- Known allergy to three or more foods or medications, allergy to GLP-1 agonists, or severe allergic diseases such as asthma, urticaria, or eczematous dermatitis
- Treatment with GLP-1 receptor agonists or similar weight control drugs within three months before screening
- Secondary or drug-induced obesity, including elevated cortisol conditions, pituitary or hypothalamic damage, or obesity due to diet drug changes
- History of pancreatitis
- Uncontrolled thyroid diseases with abnormal thyroid function test results at screening
- History of moderate or severe depression, PHQ-9 score ≥15, other serious mental illnesses, or any lifetime history of suicide attempt
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 weeks
Participants receive weekly injections of BGM0504 or placebo to evaluate the efficacy and safety of the study drug in managing overweight or obesity.
Weekly visits for up to 36 weeks
Duration - Up to 16 weeks
Participants are monitored for safety and long-term effects after completing the treatment period.
Visits at Week 52 and possibly additional assessments
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
J
Ji,MD, chief physician, Peking University People's Hospital
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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