Phase
Condition
Diabetes Prevention
Hypertriglyceridemia
Obesity
Treatment
5 mg BGM0504 injection
15 mg BGM0504 injection
10 mg BGM0504 injection administered subcutaneously (SC) once a week
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thefollowing comorbidities: i. Prediabetes (impaired fasting blood glucose and/orimpaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or oneor more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesityor 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 withchildbearing potential and their partners should use highly effective, medicallyaccepted contraception, will not have pregnancy and fertility plan, and refrain fromdonating ovum until one month after the end of the study
Exclusion
Exclusion Criteria:
Diabetes mellitus
Known to be allergic to 3 or more kinds of foods or medications, or allergic toGLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematousdermatitis, etc.) at screening
Has been treated with GLP-1 receptor agonists or similar drugs containing the sametarget, 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 dueto diet drug reduction/discontinuation, etc.;
History of pancreatitis
Have the currently uncontrolled thyroid diseases with stable treatment dose andclinically significant abnormal results of thyroid function test occurred atscreening
Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history ofother serious mental illness, or Any lifetime history of a suicide attempt
Study Design
Connect with a study center
Peking University People's Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
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