A Study of BGM0504 Injection in Participants with Obesity or Overweight

NCT ID: NCT06704581

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-28
• Study Completion Date: 2026-03-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

5 mg BGM0504 injection

Group Type: EXPERIMENTAL

5 mg BGM0504 injection

Intervention Type: DRUG

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

10 mg BGM0504 injection

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

15 mg BGM0504 injection

Group Type: EXPERIMENTAL

15 mg BGM0504 injection

Intervention Type: DRUG

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

BGM0504 placebo

Group Type: PLACEBO_COMPARATOR

BGM0504 placebo

Intervention Type: DRUG

BGM0504 placebo administered SC once a week.

Interventions

5 mg BGM0504 injection

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

15 mg BGM0504 injection

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

Intervention Type: DRUG

BGM0504 placebo

BGM0504 placebo administered SC once a week.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

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

Role: CONTACT

jiln@bjmu.edu.cn

13910978815

Facility Contacts

Chief physician, Peking University People's Hospital, PhD

Role: primary

jiln@bjmu.edu.cn

8613910978815

Other Identifiers

BGM0504-Ⅲ-WL

Identifier Type: -

Identifier Source: org_study_id