Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06704581
PHASE3

A Study of BGM0504 Injection in Participants with Obesity or Overweight

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

620

Start Date

2024-10-28

Completion Date

2026-03-27

Last Updated

2024-11-26

Healthy Volunteers

No

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.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China