NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061210009

Registered date:03/06/2021

Additional effect of luseogliflozin on semaglutide for non-alcoholic steatohepatitis patients with type 2 diabetes

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedNonalcoholic steatohepatitis
Date of first enrollment05/08/2021
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Intervention group After obtaining a written consent and completing baseline examination, Ozempic (0.25 mg) will be injected subcutaneously once a week. After 2 weeks of Ozempic treatment, one Lusefi (2.5 mg) tablet will be added once daily by orally before or after breakfast. After 4 weeks of the initial Ozempic treatment, the dose of the Ozempic (0.25 mg) will be increased to 0.5 mg. Ozempic injection will be remained once a week. Medication will be continued until 52 weeks. Control group After obtaining a written consent and completing baseline examination, Ozempic (0.25 mg) will be injected subcutaneously once a week. After 4 weeks of Ozempic treatment, the dose of the Ozempic (0.25 mg) will be increased to 0.5 mg. Ozempic injection will be remained once a week. Medication will be continued until 52 weeks.

Outcome(s)

Primary Outcome1. Resolution of NASH (defined by the NASH Clinical Research Network as no more than mild residual inflammatory cells [score of 0 or 1] and no hepatocyte ballooning [score of 0]) without worsening of liver fibrosis (with worsening defined as an increase of one stage or more on the Kleiner fibrosis classification scale) after 52 weeks, in line with regulatory perspectives 2. Improvement of at least one point in NAFLD activity score and no worsening of NASH without worsening of liver fibrosis 3. Improvement of at least one fibrosis stage and no worsening of NASH (with worsening defined as an increase of 1 point or more in either the lobular inflammation score or the hepatocyte ballooning score according to the NASH Clinical Research Network criteria)
Secondary Outcome1. Proportion of cases with progression of liver fibrosis (improvement/instability/worsening) 2. Change from baseline in liver stiffness according to FibroScan 3. Change from baseline in steatosis according to FibroScan 4. Change from baseline in weight, BMI, and body composition 5. Change from baseline in HbA1c 6. Change from baseline in liver enzymes (AST, ALT, GGT)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteriaNASH with type 2 diabetes 1. Patients aged 20 to 75 years at the time of consent 2. Patients with type 2 diabetes who were diagnosed with NASH with stage 1 or more and NAS 4 or more according to the classification of the NASH Clinical Research Network (NASH CRN) by liver biopsy within 6 months (180 days) before pre-examination or consent acquisition 3. Patients with HbA1c 6.5% or more (HbA1c 6% or more for those undergoing drug treatment) and 10.5% or less in the preliminary examination 4. Patients who provided written consent to participate in this study
Exclude criteria1. Patients who received SGLT2 inhibitors or GLP-1 receptor agonists within 3 months (90 days) prior to the start of the drug administration study or after liver biopsy 2. Patients who used other SGLT2 inhibitors or GLP-1 receptor agonists during the study period 3. Patients with a history of serious adverse reactions to SGLT2 inhibitors or GLP-1 receptor agonists in the past 4. Patients with uncompensated liver cirrhosis (Child-Pugh B or C) 5. Patients with serious renal disease (serum Cr > 2.0 mg/dL or CKD stage 4 or higher) 6. Patients with malignant tumor 7. Patients with a history of severe hypoglycemia 8. Patients with a history of ketoacidosis 9. Patients with a history of cerebral infarction with paralysis 10. Patients with urinary tract/genital infections or repeated urinary tract/genital infections 11. Patients with the following complications: hepatitis due to other causes such as viral hepatitis, autoimmune hepatitis, primary cholestatic cholangitis, psychiatric disorders, seizures, and paroxysmal diseases 12. Patients who were hospitalized for acute coronary syndrome, unstable angina, acute myocardial infarction, acute cerebral infarction, or transient ischemic attack within 3 months (90 days) prior to obtaining consent 13. Pregnant or lactating women, women who may become pregnant, or women who wish to become pregnant 14. Patients who had started or changed the dose of pioglitazone or vitamin E within 6 months (180 days) prior to starting the study drug, or within 3 months (90 days) prior to liver biopsy until starting the study drug 15. Patients who regularly use oral steroids or injectable steroids 16. Patients who are participating or intend to participate in other clinical studies using the study drug while participating in this study 17. If, in the opinion of the Principal Investigator, or others, participation in the research is not in the best interest of the research subject (e.g., to the detriment of the welfare of the research subject), or if it is judged to interfere with, limit, or confuse the specific evaluation of the clinical research protocol 18. A person under the direction of the Principal Investigator or the medical institution conducting the research, an employee of the Principal Investigator or of the medical institution directly involved in this or other clinical research, or family members of such employees or the Principal Investigator

Related Information

Contact

Public contact
Name Teruki Miyake
Address 454, Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5308
E-mail miyake.teruki.mg@ehime-u.ac.jp
Affiliation Ehime University Hospital
Scientific contact
Name Yoichi Hiasa
Address 454, Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5308
E-mail hiasa@m.ehime-u.ac.jp
Affiliation Ehime University Hospital