RecruitingPhase 3NCT06704581

A Study of BGM0504 Injection in Participants with Obesity or Overweight

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


Sponsor

BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

Enrollment

620 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 10 mg BGM0504 injection administered subcutaneously (SC) once a week, a drug called 15 mg BGM0504 injection, and others for people with overweight or obesity. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG5 mg BGM0504 injection

5mg BGM0504 injection administered subcutaneously (SC) once a week.

DRUG10 mg BGM0504 injection administered subcutaneously (SC) once a week

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

DRUG15 mg BGM0504 injection

15mg BGM0504 injection administered subcutaneously (SC) once a week.

DRUGBGM0504 placebo

BGM0504 placebo administered SC once a week.


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06704581


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