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Clinical Trials in China / NCT06704581
Recruiting Phase 3

A Study of BGM0504 Injection in Participants with Obesity or Overweight

NCT06704581 · tracked via the Priya Life Science China tracker
Sponsor
BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
Phase
Phase 3
Started
2024-10-28
Last updated
2024-11-26

Condition(s) studied

Overweight or Obesity

Investigational drug(s) / intervention(s)

5 mg BGM0504 injection →10 mg BGM0504 injection administered subcutaneously (SC) once a week15 mg BGM0504 injection →BGM0504 placebo

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

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

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

BGM0504 placebo: BGM0504 placebo administered SC once a week.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06704581 on ClinicalTrials.gov ↗ ← All trials in China