Actively Recruiting
A Study of BGM0504 Injection in Participants with Obesity or Overweight
Led by BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd. · Updated on 2024-11-26
620
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of BGM0504 Injection in Participants with Obesity or Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A male or female aged 18 to 65 years inclusive at screening
- BMI9 kg/m�b2, or 24.08 BMI <28.0 kg/m�b2 and previous diagnosis 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 plan until one month after study end
You will not qualify if you...
- Diagnosis of diabetes mellitus
- Allergic to 3 or more foods or medications, allergic to GLP-1 agonist, 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 prior to screening
- Secondary or drug-induced obesity including elevated cortisol conditions (e.g., Cushing's syndrome), pituitary or hypothalamic damage, or obesity due to diet drug reduction/discontinuation
- History of pancreatitis
- Uncontrolled thyroid diseases with clinically significant abnormal thyroid function test results at screening
- History of moderate or severe depression, PHQ-9 score 15 or higher, other serious mental illness, or any lifetime suicide attempt
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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