Tirzepatide's Effect on Liver Health in Obesity
Tirzepatide
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Other Study
Summary
Study start date: June 30, 2025
Actual date on which the first participant was enrolled.Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a widespread liver condition that mainly affects those with obesity, type 2 diabetes, and heart-related issues. Tirzepatide, a drug commonly used for treating type 2 diabetes and obesity, shows promise in helping with MASLD. This study aims to explore how tirzepatide impacts the liver health of individuals suffering from MASLD. By understanding how this medication works in the liver, the study hopes to find better ways to manage or treat this common liver disease. Participants in the study will take tirzepatide for a year. They will visit the clinic every three months and undergo blood tests at the start, halfway through, and at the end of the study. Additionally, participants will have a liver ultrasound both at the beginning and the end of the study period. These steps help researchers evaluate how the liver responds to tirzepatide over time, providing valuable insights into the medication's effectiveness and safety for those with MASLD.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Men and women * Age 18-75 * Diagnosis of MASLD based on the following criteria: * Presence of at least 1 out of the 5 following cardiometabolic criteria: * BMI \>25 kg/m2 OR waist circumference \>94 cm (men) or 80cm (women) * Fasting serum glucose \>100 mg/dL OR 2-hour post-prandial glucose levels \>140mg/dL OR AbA1c \>5.7% OR type 2 diabetes OR treatment for type 2 diabetes * Blood pressure \>130/85 mmHg OR specific antihypertensive drug treatment * Plasma triglycerides \>150mg/dL OR on lipid lowering treatment * Plasma HDL-cholesterol \<40mg/dL (men) and \<50mg/dL (women) OR on lipid lowering medication * No other identified causes of steatosis * Evidence of steatotic liver disease (hepatic steatosis identified by imaging or biopsy) * English speaking Exclusion Criteria: * Pregnancy or breast feeding * Premenopausal women not on any form of contraception * Reports alcohol intake \>50g/day or 350g/week for women and \>60g/day or 420g/week for men or an AUDIT score \>8 * Other identifiable causes of steatosis * Documented allergic reaction to tirzepatide or any other GLP1 RA * Decompensated liver disease * Decompensated renal disease requiring hemodialysis * Decompensated heart failure * Active malignancy * Prior history of pancreatitis * Serum triglyceride levels \>500 mg/dL * Personal or family history of medullary thyroid cancer or MEN2a or MEN2b * Concurrent use of other ant-obesity medications * Use of other GLP1 RAs within 3 months of study enrollment * Unable to obtain the medication due to cost or insurance coverage restrictions.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of New Mexico Health Sciences Center
Albuquerque, United StatesOpen University of New Mexico Health Sciences Center in Google Maps