obesity and steatotic liver disease
Conditions
Interventions
Tirzepatide will be administered for 24 weeks to patients with obesity and steatotic liver disease after curative treatment for hepatocellular carcinoma (HCC).
Sponsors
Tateishi Ryosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who have achieved a complete response (CR) for hepatocellular carcinoma (HCC) through curative local therapies such as hepatic resection or radiofrequency ablation. (2) Patients with no signs of HCC recurrence at the time of informed consent. (3) Patients with obesity complicated by hypertension, dyslipidemia, or type 2 diabetes mellitus, who have not achieved sufficient results despite diet and exercise therapy, and meet either of the following a) BMI >= 27 kg/m2 with two or more obesity-related health disorders. b) BMI >= 35 kg/m2 (4) Patients who have received continuous nutritional guidance from a registered dietitian along with diet and exercise therapy for 6 months or longer. However, guidance regarding diet therapy must have been conducted at least once every 2 months. (5) Patients with Child Pugh class A. (6) Patients aged 18 years or older at the time of informed consent. (7) Sex Not specified. (8) Patients who have provided voluntary written informed consent after receiving sufficient explanation and achieving full understanding regarding participation in this study. (9) Patients capable of attending outpatient visits according to the research implementation schedule.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of pancreatitis, biliary tract disease (cholecystitis, cholangitis), or ileus. (2) Patients with a history of decompensated liver cirrhosis. (3) Patients with severe gastrointestinal disorders. (4) Patients with a history of diabetic ketoacidosis, diabetic coma, or pre-coma, or patients with type 1 diabetes mellitus. (5) For patients with type 2 diabetes mellitus, those in a state requiring emergency response such as severe infection or surgery. (6) Patients who are pregnant, breastfeeding, or possibly pregnant. (7) Patients with a history of hypersensitivity to the components of tirzepatide. (8) Patients with a personal or family history of medullary thyroid carcinoma, or patients with multiple endocrine neoplasia type 2 (MEN2) (9) Other patients judged by the principal investigator or sub-investigator to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious acute pancreatitis regardless of causality | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Percent change in body weight (2) Changes in body composition parameters (3) Change in HbA1c, lipids (LDL cholesterol, triglycerides), and blood pressure (4) Change in liver function markers (AST, ALT) (5) Fluctuations in liver functional reserve markers (Child-Pugh score, ALBI score ) (6) Change in liver stiffness (LS) and controlled attenuation parameter (CAP) measured by FibroScan (7) Change in serum fibrosis and hepatocyte injury markers (ELF score, CK-18F, FIB-4 index) (8) Recurrence rate of hepatocellular carcinoma (9) Discontinuation rate (10) Incidence of drug-specific serious adverse events (11) Incidence of liver decompensation events (12) Incidence of all adverse events | — |
Contacts
Public ContactYuki Matushita
The University of Tokyo Hospital
Outcome results
None listed