Dyslipidemia, MASLD
Conditions
Interventions
BGT-002 group:BGT-002 tablets 200 mg, oral, BIW
placebo group:placebo tablets, oral, BIW
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged >=18 years old and =18 kg/m^2 and =100 mg/dL (2.6 mmol/L) and = 150 mg/dL (1.7 mmol/L) and =10% during screening period (MRI-PDFF); 7.No plans to have children during the trial and within 6 months after the last medication and able to take reliable contraceptive measures; 8.Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and be able to complete the entire trial process according to the trial requirements.
Exclusion criteria
Exclusion criteria: 1.Genetic or clinical diagnosis of homozygous familial hypercholesterolemia; 2.Those who are known to have a history of allergy, allergic disease or allergic constitution to the test preparation, any of its ingredients or related preparations; 3.The patient is known to have serious, uncontrolled concomitant diseases that may affect regimen compliance or have a significant impact on blood lipid levels, including but not limited to severe active infection, anemia, chronic kidney disease, peptic ulcer, colitis, hyperthyroidism, systemic lupus erythematosus and other systemic diseases; 4.History of malignant tumor before screening (Note: 1. Subjects with cervical carcinoma in situ that has been resected and has no recurrence or metastatic evidence for at least 3 years can participate in this study; 2. Subjects with basal cell or squamous cell carcinoma that has been completely resected and has no recurrence for at least 3 years can participate in this study); 5.Uncontrolled hypertension, defined as resting systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg, averaged over three replicates; 6.Patients diagnosed with acute or chronic heart failure and New York Heart Association (NYHA) class III or IV, or with a left ventricular ejection fraction of less than 40% detected in the past three months; 7.Severe cardiovascular and cerebrovascular events occurred within 3 months before screening, including but not limited to uncontrolled or severe arrhythmias (such as ventricular fibrillation, atrial fibrillation, etc.), acute myocardial infarction, congestive heart failure, coronary artery intervention (including stent thrombosis or coronary artery bypass grafting), peripheral vascular intervention, stroke (excluding lacunar infarction), and transient ischemic attack; 8.Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c >= 10% at screening); 9.Presence of gastrointestinal diseases or postoperative conditions that affect drug absorption; 10.Patients who are currently taking or have a history of the following medications/treatments: • Statins or cholesterol absorption inhibitors taken within 6 weeks prior to the screening visit; • ATP citrate lyase (ACLY) inhibitors taken within 4 weeks prior to the screening visit; • Cholesterol ester transfer protein (CETP) inhibitors taken within 2 years prior to the screening visit; • Plan to change the type of systemic steroid hormones or the original dose during the study; stable doses of systemic steroid hormones and topical steroid hormones are allowed within 12 weeks prior to the screening visit; • Patients who have used proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors (such as Evolocumab, Alirocumab) within 4 weeks prior to the screening visit, or who have used inclisiran sodium within 6 months prior to the screening visit; • Lipoprotein plasma exchange performed 12 weeks prior to the screening visit; • Patients who had taken cholesterol-lowering drugs other than statins and cholesterol absorption inhibitors, or drugs or health products with lipid-regulating effects as determined by the investigator within 4 weeks before the screening visit, such as red yeast rice, Xuezhikang, niacin > 200 mg/day, omega-3 fatty acids > 1000 mg/day, stanols or lipid-regulating drugs (such as bile acid sequestrants, fibrates, and niacin and its derivatives). 11.Plan to start the following medications during the clinical trial or change medications before randomization: • Use ho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL cholesterol; | — |
Secondary
| Measure | Time frame |
|---|---|
| Triglycerides;Fibroscan stiffness;Total cholesterol;renal function parameters;Physical examination (height?weight,waist circumference,hip circumference);ECG;Liver fat content by MRI-PDFF;liver enzymes;Fibroscan CAP value;AE and SAE;Vital sign;Non-HDL cholesterol; | — |
Countries
China
Contacts
Public ContactXIA MINGFENG
Zhongshan Hospital, Fudan University
Outcome results
None listed