The tofogliflozin-pemafibrate combination therapy for metabolic dysfunction-associated fatty liver disease

JRCT ID: jRCTs021240006

Registered date:01/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes,dyslipidemia,MAFLD
• Date of first enrollment: 01/05/2024
• Target sample size: 38
• Study type: Interventional
• Intervention(s): The principal investigator or research associate obtains written consent to participate in the study and determines eligibility by confirming that subjects meet the selection criteria and do not violate the exclusion criteria as a result of screening tests. For subjects determined to be eligible, case enrollment will be conducted and allocation will be made. Based on the allocation results, subjects in the "tofogliflozin group" will start to receive 20 mg/day of tofogliflozin, and subjects in the "tofogliflozin + pemafibrate group" will receive 20 mg/day of tofogliflozin and 0.2 mg/day of pemafibrate simultaneously. The observation points will be before the start of treatment, 12 weeks after the start of treatment, and 24 weeks after the start of treatment, and the allowable data acquisition period for each observation point will be 4 weeks before and after the start of treatment. Additional blood samples will be taken at the pre-initiation and at the 12- and 24-week observation points when blood samples are taken at the usual clinic visit.

Outcome(s)

• Primary Outcome: Percent change from baseline in ALT at 24 weeks (between groups)

Secondary Outcome

1. percent change from baseline in ALT at 24 weeks for each group (before/after comparison)
2. percent change from baseline in ALT at 12 weeks (between group comparison)
3. percent change from baseline in ALT at 12 weeks for each group (before/after comparison)
4. percent change from baseline in various biochemical parameters at 24 weeks (group comparison) .
5. percent change from baseline in various biochemical tests at 24 weeks for each group (before/after comparison)
6. percent change from baseline in various biochemical parameters (excluding special tests) at 12 weeks (group comparison)
7. percent change from baseline in biochemical parameters (excluding special tests) at 12 weeks for each group (before and after comparison)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Waki Hironori
• Source(s) of Monetary Support: Kowa Company, Ltd.