Non-alcoholic steatohepatitis
Conditions
Interventions
50mg-A:take BGT-002 orally
50mg-B:take BGT-002 placebo orally
75mg-A:take BGT-002 orally
75mg-B:take BGT-002 placebo orally
100mg-A:take BGT-002 orally
100mg-B:take BGT-002 placebo orally
125mg-A:take BGT-002 orally
125mg-B:take BGT-002 placebo orally
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)18-year-old =65-year-old, male or female; 2)BMI =25 kg/m^2 at screening; 3)subjects met the following criteria: a) Alt was greater than the upper limit of normal once within 3 months (no other obvious reason for ALT elevation); b) mean liver fat content=10%(MRI-PDFF) at the end of screening and induction period; 4)body weight was stable 4-8 weeks before treatment, defined as weight gain or loss =5%; 5)systolic blood pressure =160mmhg and diastolic blood pressure =95mmhg before drug administration; 6)the same medication and lifestyle (diet and/or exercise) were maintained at the time of enrollment during the trial; 7)no family planning and voluntary adoption of reliable contraception measures within 6 months after screening to the last drug administration; 8)fully understanding the objectives and requirements of the trial, voluntarily participating in the clinical trial and signing a written informed consent, and able to complete the whole trial according to the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1) known history of allergy, allergic disease or allergic constitution to the test preparation and any of its components or related preparations; 2) high alcohol intake for 3 consecutive months or more within 1 year prior to screening, defined as: average daily alcohol intake of women>20 g, average daily alcohol intake of men>30 g, or uncontrolled alcohol intake; 3) liver biopsy indicating cirrhosis or clinical diagnosis of cirrhosis; 4) other comorbid liver diseases including but not limited to: drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, hemochromatosis, Wilson disease, suspected or confirmed liver cancer; 5) history of liver transplantation or planned liver transplantation; 6) previous or planned bariatric surgery during the study period; 7) Type 1 diabetes and poorly controlled type 2 diabetes (HbA1c > 10.5% at screening) 8) diabetic patients using hypoglycemic agents other than metformin; 9) history of malignancy within 5 years before screening (Note: Participants with cervical carcinoma in situ who had been resected and had no evidence of recurrence or metastasis for at least 3 years were eligible for this study. 2. Participants with basal cell or squamous cell carcinoma who had been completely resected and had no recurrence for at least 3 years were eligible to participate in the study; 10) had a serious cardio-cerebrovascular event within 6 months before screening, including, but not limited to, uncontrolled or severe arrhythmias (e.g., ventricular fibrillation, atrial fibrillation, etc.), unstable angina, acute myocardial infarction, heart failure, coronary intervention (including stent thrombosis) or coronary artery bypass surgery, peripheral vascular intervention, stroke (except lacunar infarction) , transient cerebral ischemia; 11) presence of gastrointestinal disease that affects drug absorption; 12) being on medication that may cause steatosis steatohepatitis; 13 Those who have used targeted ACLY drugs (including NEXLETOL, etc.), or are taking statins (lovastatin, simvastatin, pravastatin, mevastatin, fluvastatin, Atorvastatin, cilastatin, rovastatin, pitavastatin, etc.) , Atorvastatin (non-Norbert, Gemfibrozil) , probucol, Warfarin, systemic steroids, cyclosporine, or other immunosuppressants, or tacked other investigational drugs within 1 month or 5 half-lives of the drug before BGT-002 administration(whichever is longer) 14) Drugs with potential Nash effects were used 1 month before the screening period and during the trial period (e.g., GLP-1 receptor agonists, DPP4 inhibitors, SGLT2 inhibitors, or other drugs known to affect liver function and steatosis as decided by the investigators) ; 15) TG>6.0 mmol/L, direct bilirubin>2 × ULN, creatinine clearance<60 mL/min (calculated using Cockcroft Gault formula) ; 16) platelet count<75 × 10 ^ 9/L; 17) positive and clinically significant Ana confirmation during the screening period; 18) history of hypothyroidism, hyperthyroidism, or subclinical thyroid disease (except those TSH < 10 mu/L, free T3, T4 in normal range, and without hypothyroidism symptoms); 19) patients with contraindications MRI scanning; 20) those who had blood donation or blood loss =400 mL within 3 months before screening; 21) those who had participated in other drug clinical trials within 1 month before screening; 22) pregnant/lactating women or those with positive serum pregnancy tests (women); 23) those who had positive urine drug screenin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms and physical examination;Clinical laboratory examination;Vital signs;12-lead ECG; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) parameters;Pharmacokinetic (PD) parameters; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed