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

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Completed; Phase 2

Conditions: Overweight or Obesity

Treatments: Drug: BGM0504; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06973681

BGM0504-II-WL

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 4 patient groups, including a placebo group

5 mg BGM0504

Experimental group

Description:

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

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

10 mg BGM0504

Experimental group

Description:

10 mg BGM0504 administered SC once a week.

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

15 mg BGM0504

Experimental group

Description:

15 mg BGM0504 administered SC once a week.

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Placebo

Placebo Comparator group

Description:

Placebo administered SC once a week.

Treatment:

Drug: Placebo