A Study of BGM0504 Injection in Participants with Obesity or Overweight

NCT06704581 | Recruiting Phase 3 FDA Drug

• 1 other identifier: BGM0504-Ⅲ-WL
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percent Change from Baseline in Body Weight

  Change from baseline in body weight after 36 weeks of treatment

  Baseline,Week 36

• Percentage of Participants Who Achieve≥5% Body Weight Reduction

  Percentage of Participants Who Achieve≥5% Body Weight Reduction

  Baseline,Week 36

Secondary Outcomes (10)

• Percent Change From Baseline in Body Weight

  Baseline, Week 52

• Change From Baseline in Body Weight

  Baseline, Week36 and 52

• Percentage of Participants Who Achieve≥5% Body Weight Reduction

  Baseline, Week 36 and 52

• Percentage of Participants Who Achieve≥10% Body Weight Reduction

  Baseline, Week 36 and 52

• Percentage of Participants Who Achieve≥15%Body Weight Reduction

  Baseline, Week 36 and 52

Study Arms (4)

5 mg BGM0504 injection

EXPERIMENTAL

Drug: 5 mg BGM0504 injection

10 mg BGM0504 injection

EXPERIMENTAL

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

15 mg BGM0504 injection

EXPERIMENTAL

Drug: 15 mg BGM0504 injection

BGM0504 placebo

PLACEBO COMPARATOR

Drug: BGM0504 placebo

Interventions

5 mg BGM0504 injection DRUG

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

5 mg BGM0504 injection

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

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

10 mg BGM0504 injection

15 mg BGM0504 injection DRUG

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

15 mg BGM0504 injection

BGM0504 placebo DRUG

BGM0504 placebo administered SC once a week.

BGM0504 placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

13910978815; jiln@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 26, 2024
• Study Start: October 28, 2024
• Primary Completion: November 27, 2025
• Study Completion: March 27, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

CN (1)