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A Study of BGM0504 Injection in Participants with Obesity or Overweight

NCT06704581 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2024-11-26

No results posted yet for this study

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.

Conditions

  • Overweight or Obesity

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.

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2025-11-27
Completion
2026-03-27
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06704581 on ClinicalTrials.gov