Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059367) titled 'A Single-Center Prospective Interventional Study of Tirzepatide in Obese Patients with steatotic liver disease: Exploring Its Effects on Body Weight, Liver Function, and Histology' on Oct. 17.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - nagano red cross hospital
Condition:
Condition - Obesity patients with MASLD
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to systematically assess the short- to mid-term efficacy and safety of tirzepatide in obese patients with MASLD, using body weight, liver function, and liver histology as co-primary endpoints.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Tirzepatide
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key 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
Key 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
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 29 Day
Date of IRB - 2025 Year 09 Month 29 Day
Anticipated trial start date - 2025 Year 10 Month 17 Day
Last follow-up date - 2030 Year 10 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067900
Disclaimer: Curated by HT Syndication.
