臨床研究等提出・公開システム

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

TOP-COMACHI study

Waki Hironori

Akita University Hospital

44-2 Hasunuma Hiroomote, Akita-shi, Japan

dm-akita@gipc.akita-u.ac.jp

Nishida Hirokazu

Iwama pharmacy

3-11-60 Yokomori, Akita City, Akita Prefecture

+81-18-827-4884

infotrial@iwama-ph.co.jp

Recruiting

May. 01, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

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)

Both

Type 2 diabetes,dyslipidemia,MAFLD

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.

Type 2 diabetes,dyslipidemia,MAFLD

E11,E78.5

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

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)

+81-18-884-6461

Jan. 17, 2024

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