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Efficacy and safety of imeglimin hydrochloride for non-alcoholic fatty liver disease with type 2 diabetes: single-center, single-arm phase II study (IMELD Study)

Imeglimin hydrochloride for NAFLD with type 2 diabetes: phase II study (IMELD Study)

Kitano Masayuki

Wakayama Medical University Hospital

811-1 Kimiidera, Wakayama City, Wakayama, Japan

kitano@wakayama-med.ac.jp

Yamada Hiroki

Wakayama Medical University Hospital

811-1 Kimiidera, Wakayama City, Wakayama, Japan

+81-73-447-2300

h-yamada@wakayama-med.ac.jp

Not Recruiting

Sept. 15, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Patients with NAFLD.
(2) Patients with ALT value of 31U/L or higher.
(3) Patients with type 2 diabetes with HbA1c level of 6.5% or higher.
(4) Patients aged 18 years or older at the time of providing consent.
(5) Patients who have provided written consent to inclusion in this study.

(1) Patients with a habit of drinking alcohol (30 g/day or more of ethanol for men, 20 g/day or more of ethanol for women).
(2) Patients diagnosed with viral hepatitis, with the exception of the following cases, which are allowed:
-Persistent virological response (SVR) after hepatitis C treatment.
-HCV-RNA is not detected even if HCV antibody is positive.
-The following cases of past hepatitis B virus infection:
-HBsAg negative and HBs antibody positive.
-HBsAg negative and HBc antibody positive.
(3) Patients diagnosed with drug-induced liver injury, autoimmune hepatitis, or primary biliary cholangitis.
(4) Patients with decompensated cirrhosis (Child-Pugh classification B or C).
(5) Patients with eGFR < 45mL/min/1.73m2.
(6) Patients with type 1 diabetes.
(7) Patients diagnosed with mitochondrial diabetes.
(8) Patients receiving corticosteroid treatment by oral administration or injection.
(9) Patients with severe ketosis or diabetic coma/precoma.
(10) Patients with malignant tumors, or who have been treated for malignant tumors within the past year (however, treatment history for basal cell carcinoma of the skin, squamous cell carcinoma in situ is acceptable).
(11) Patients who have started or changed vitamin E preparations or diabetes treatments within 24 weeks before the time of enrollment.
(12) Patients on insulin treatment or considered to be an absolute indication for insulin.
(13) Patients with active infections requiring systemic treatment.
(14) Patients with severe trauma.
(15) Patients with a history of surgery within the last 12 weeks from the time of enrollment.
(16) Patients with acute coronary syndrome, heart failure, stroke, or transient ischemic attack within 12 weeks before enrollment.
(17) Patients with a history of hypersensitivity to imeglimin hydrochloride components.
(18) Patients who are pregnant, breastfeeding, or may be pregnant.
(19) Patients unable to undergo MRI examination and those for whom it is contraindicated (pacemaker placement, claustrophobia, or difficulty holding breath, etc).
(20) Patients who are otherwise judged to be inappropriate for this study by the principal investigator or research co-investigator.

Both

NAFLD with type 2 diabetes

After providing written consent, patients with NAFLD with type 2 diabetes will undergo an eligibility test during the screening period and eligible cases will be registered. The registered cases will be treated for 24 (+-2)weeks. After the end of the treatment period, the usefulness of 24-week administration of imeglimin hydrochloride in patients with NAFLD and type 2 diabetes will be examined using the decrease in ALT value (primary endpoint) after administration of imeglimin hydrochloride administration as an index.

Reduction in ALT after 24-week administration of imeglimin hydrochloride.

(1) Amount of decrease in ALT value after 12-week administration of imeglimin hydrochloride.
(2) Changes in the following values after 12 and 24 weeks of administration of imeglimin hydrochloride.
-AST,GGTP
-HbA1c
-HOMA-B,HOMA-IR
-BMI
-Body weight
-Body fat mass
-Body fat percentage
-Marker of liver fibrosis (M2BPGi, FIB-4 index, NAFLD fibrosis score, Ultrasonic elastography: Shear Wave Elastography)
-Liver fat mass (Ultrasonic attenuation method [Attenuation Imaging:ATI],MRI-PDFF [LiverLab])
(3) Normalization rate of ALT value after 12-week administration and after 24-week administration of imeglimin hydrochloride (rate of improvement of ALT value to 30U/L or less).
(4) Frequency and severity of side effects (hypoglycemia, nausea, diarrhea, constipation, etc.), evaluated using CTCAEver5.0).

+81-73-441-0896

Aug. 31, 2022

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