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

Phase 2

Completed

• Conditions: Overweight or Obesity
• Interventions: Drug: BGM0504; Drug: Placebo

• Registration Number: NCT06973681
• Lead Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-10-13
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-13
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Exclusion Criteria

1.Those who have used weight loss drugs within 12 weeks before screening; 2. Previous diagnosis of type 1 or type 2 diabetes mellitus; 3. History of acute or chronic pancreatitis, or pancreatic injury; 4. History of thyroid C-cell carcinoma, MEN (multiple endocrine adenomatosis) 2A or 2B, or relevant family history; 5. Subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening) or untreated blood pressure meeting the above criteria at screening; 6. Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose atscreening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy; 7. At Screening, abdominal ultrasound indicated calculus gallbladder and polyps, or presence of clinical symptoms of gallbladder disease at Screening; 8. Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 mg BGM0504	BGM0504	5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
10 mg BGM0504	BGM0504	10 mg BGM0504 administered SC once a week.
15 mg BGM0504	BGM0504	15 mg BGM0504 administered SC once a week.
Placebo	Placebo	Placebo administered SC once a week.

Primary Outcome Measures

Name	Time	Method
Percentage change in body weight	Week 0 to Week 24	Percentage change from baseline in body weight after 24 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects with weight loss of ≥5%	Week 0 to Week 24	Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
Change from baseline in waist circumference	Week 0 to Week 24	Change from baseline in waist circumference after 24 weeks of treatment
Change from baseline in BMI	Week 0 to Week 24	Change from baseline in BMI after 24 weeks of treatment
Change from baseline in fasting plasma glucose (FPG)	Week 0 to Week 24	Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, China