Obesity patients with MASLD
Conditions
Interventions
Tirzepatide
Sponsors
nagano red cross hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 18 and 75 years Body mass index (BMI) over 27 kg/m2, consistent with domestic regulatory criteria Diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) according to current clinical practice guidelines The principal investigator determines that tirzepatide is clinically indicated Basic Conditions Diagnosis of hypertension, dyslipidemia, or type 2 diabetes mellitus Lifestyle Modification Insufficient response to at least 6 months of lifestyle intervention, including dietary and exercise therapy BMI and Obesity-Related Comorbidities Eligible participants must meet one of the following conditions: BMI over 35 kg/m2, or BMI over 27 kg/m2 with two or more obesity-related comorbidities, including: Impaired glucose tolerance (diabetes, borderline diabetes, etc.) Dyslipidemia Hypertension Hyperuricemia or gout Coronary artery disease (myocardial infarction, angina pectoris) Cerebral infarction or transient ischemic attack Nonalcoholic fatty liver disease (NAFLD) / Nonalcoholic steatohepatitis (NASH) Menstrual disorders or female infertility Obstructive sleep apnea syndrome (SAS) Obesity hypoventilation syndrome Musculoskeletal disorders (e.g., osteoarthritis of the knee or hip) Obesity-related kidney disease Written informed consent obtained prior to enrollment Baseline liver biopsy performed within 3 months before study initiation or scheduled to be performed prior to treatment
Exclusion criteria
Exclusion criteria: Decompensated liver cirrhosis (Child-Pugh class B or C) History of pancreatitis, or active gallstones or cholecystitis Planned initiation of other anti-obesity or incretin-based medications within the next 6 months Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2, severe heart failure, active malignancy, or pregnancy/lactation Any other condition that the principal investigator considers inappropriate for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Percent change in body weight from baseline at 6 months. 2)Percent change in alanine aminotransferase (ALT) from baseline at 6 months. 3)Proportion of patients showing a over 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis on repeat liver biopsy at 6-12 months. | — |
Countries
Japan
Contacts
Public ContactYuki Yamashita
nagano red cross hospital Gastroenterology
Outcome results
None listed