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RECRUITINGPHASE3

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

NCT06704581•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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A male or female aged 18 to 65 years inclusive at screening
•BMI≥28 kg/m², or 24.0≤BMI\<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesity or obstructive sleep apnea syndrome
•Weight change \< 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening
•Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study

Exclusion Criteria

•Diabetes mellitus
•Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening
•Has been treated with GLP-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening
•Secondary disease or drug-induced obesity, including : elevated cortisol (e.g. Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.;
•History of pancreatitis
•Have the currently uncontrolled thyroid diseases with stable treatment dose and clinically significant abnormal results of thyroid function test occurred at screening
•Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history of other serious mental illness, or Any lifetime history of a suicide attempt

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

October 28, 2024

Primary Completion Date

November 27, 2025

Completion Date

March 27, 2026

Last Updated

November 26, 2024

Enrollment

620

ESTIMATED participants

Conditions

Overweight or Obesity

Interventions

5 mg BGM0504 injection

DRUG

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

DRUG

15 mg BGM0504 injection

DRUG

BGM0504 placebo

DRUG

Contacts

Ji,MD, chief physician, Peking University People's Hospital

CONTACT

13910978815 jiln@bjmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of BGM0504 Injection in Participants with Obesity or Overweight

Inclusion Criteria

Exclusion Criteria

A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity

Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects

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