A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects

NCT ID: NCT06973681

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-13

Study Completion Date

2024-09-13

Brief Summary

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To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.

Detailed Description

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Conditions

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Overweight or Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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5 mg BGM0504

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

Group Type EXPERIMENTAL

BGM0504

Intervention Type DRUG

Administered SC

10 mg BGM0504

10 mg BGM0504 administered SC once a week.

Group Type EXPERIMENTAL

BGM0504

Intervention Type DRUG

Administered SC

15 mg BGM0504

15 mg BGM0504 administered SC once a week.

Group Type EXPERIMENTAL

BGM0504

Intervention Type DRUG

Administered SC

Placebo

Placebo administered SC once a week.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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BGM0504

Administered SC

Intervention Type DRUG

BGM0504

Administered SC

Intervention Type DRUG

BGM0504

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. BMI ≥ 28.0 kg/m2 or 24.0 ≤ BMI \< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit; 2.Controlled by diet and exercise alone for at least 12 weeks prior to Screening with \<5.0% change in body weight and able to continue the original diet and exercise for weight control during the trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BrightGene Bio-Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Third Xiangya Hospital of Central South University

Changsha, , China

Site Status

Countries

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China

Other Identifiers

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BGM0504-II-WL

Identifier Type: -

Identifier Source: org_study_id

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