A Study of BGM0504 Injection in Participants with Obesity or Overweight

Phase 3

Recruiting

• Conditions: Overweight or Obesity
• Interventions: Drug: 5 mg BGM0504 injection; Drug: 10 mg BGM0504 injection administered subcutaneously (SC) once a week; Drug: 15 mg BGM0504 injection; Drug: BGM0504 placebo

• Registration Number: NCT06704581
• Lead Sponsor: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-28
• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-11-27
• Study Completion: 2026-03-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 620

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 mg BGM0504 injection	5 mg BGM0504 injection	-
10 mg BGM0504 injection	10 mg BGM0504 injection administered subcutaneously (SC) once a week	-
15 mg BGM0504 injection	15 mg BGM0504 injection	-
BGM0504 placebo	BGM0504 placebo	-

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline,Week 36	Change from baseline in body weight after 36 weeks of treatment
Percentage of Participants Who Achieve≥5% Body Weight Reduction	Baseline,Week 36	Percentage of Participants Who Achieve≥5% Body Weight Reduction

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Body Weight	Baseline, Week 52	Percent Change from Baseline in Body Weight after 52weeks of treatment
Change From Baseline in Body Weight	Baseline, Week36 and 52	Change from baseline in body weight
Percentage of Participants Who Achieve≥5% Body Weight Reduction	Baseline, Week 36 and 52	Percentage of Participants Who Achieve≥5% Body Weight Reduction
Percentage of Participants Who Achieve≥10% Body Weight Reduction	Baseline, Week 36 and 52	Percentage of Participants Who Achieve≥10% Body Weight Reduction
Percentage of Participants Who Achieve≥15%Body Weight Reduction	Baseline, Week 36 and 52	Percentage of Participants Who Achieve≥15%Body Weight Reduction
Percentage of Participants Who Achieve≥20% Body Weight Reduction	Baseline, Week 36 and 52	Percentage of Participants Who Achieve≥20% Body Weight Reduction.
Change From Baseline in Waist Circumference	Baseline, Week 36 and 52	Change From Baseline in Waist Circumference after 52weeks of treatment.
Change From Baseline in Body Mass Index (BMI)	Baseline, Week 36 and 52	Change From Baseline in Body Mass Index (BMI) after 52weeks of treatment
Change From Baseline in Fasting Glucose	Baseline, Week 36 and 52	Change From Baseline in Fasting Glucose after 52weeks of treatment
Change From Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 36 and 52	Change From Baseline in Hemoglobin A1c (HbA1c) after 52weeks of treatment.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China