Phase
Condition
Liver Disease
Obesity
Primary Biliary Cholangitis
Treatment
semaglutide
IBI362
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, age 18 years or older at the time of signing informed consent
diagnosed as MAFLD according to the Chinese Guideline for the prevention andtreatment of metabolic dysfunction-associated (non-alcoholic) fatty liver disease (Version 2024)
liver fat content ≥8% measured by MRI-PDFF
BMI≥27 kg/m2
Weight change ≤5% within 3 months before screening
HbA1c≤10%
Exclusion
Exclusion Criteria:
Subjects who the investigator thinks may be allergic to the components in the studydrug or similar drugs
Used drugs or alternative therapies with weight loss effects within 3 months beforescreening, including but not limited to: GLP-1 receptor agonists, orlistat,phenylpropanolamine, chlorpheniramine, phentermine etc.
Received chronic (>2 weeks) systemic glucocorticoid treatment within 3 months beforescreening (excluding topical, intraocular, intranasal, and inhaled administration)
Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes)
Active or untreated malignant tumors within 5 years before screening, or patientsare in remission of clinical malignant tumors (except patients with skin basal cellcarcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostatecarcinoma in situ or papillary thyroid carcinoma who have no recurrence aftersurgery)
Mental illness existed in the past or at the time of screening, and the researcherthinks it is not suitable to participate in this study
Pregnant or lactating women, or men or women who are fertile and unwilling to usecontraception throughout the study period
Study Design
Connect with a study center
Beijing Hospital
Beijing, Beijing Municipality 100730
ChinaSite Not Available

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