The tofogliflozin-pemafibrate combination therapy for metabolic dysfunction-associated fatty liver disease complicated with type 2 diabetes and hyperlipidemia (TOP-COMACHI study)

未提供0 个研究点目标入组 38 人开始时间: 待定最近更新: 2024年9月5日

试验速览

暂无简介。

•Men and women over 18 years old
•Patients diagnosed with type 2 diabetes
•Patients with HbA1c of 6.0-9.0% at screening (within 12 weeks of enrollment)
•Patients diagnosed with dyslipidemia (hyperlipidemia)
•Patients with ALT between 31 IU/L and 100 IU/L at screening (within 12 weeks of enrollment)
•Patients with fatty liver on previous imaging such as ultrasonography and CT
•Written consent has been obtained prior to the study

•Patients deemed by the physician to be inappropriate for study participation (e.g., excessive alcohol consumption, uncontrolled malignancy)
•Patients with contraindications to pemafibrate
•Patients with contraindications to tofogliflozin
•Patients receiving other SGLT2 inhibitors or PPAR-alpha agonists within 6 months of enrollment
•Patients with viral hepatitis
•Patients with fasting or nonfasting triglyceride levels greater than 500 mg/dL at screening (within 12 weeks of enrollment)

Percent change from baseline in ALT at 24 weeks (between groups)

percent change from baseline in ALT at 24 weeks for each group(24 weeks)
percent change from baseline in ALT at 12 weeks(12 weeks)
percent change from baseline in ALT at 12 weeks for each group(12 weeks)
percent change from baseline in various biochemical parameters at 24 weeks(24 weeks)
percent change from baseline in various biochemical tests at 24 weeks for each group(24 weeks)
percent change from baseline in various biochemical parameters (excluding special tests) at 12 weeks(12 weeks)
percent change from baseline in biochemical parameters (excluding special tests) at 12 weeks for each group(12 weeks)

发起方

未提供