MASLD, Obesity
Conditions
Brief summary
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease worldwide and predominately affects individuals with overweight and obesity, as well as those with type 2 diabetes and cardiovascular disease. Tirzepatide is a medication used to treat type 2 diabetes and obesity. It has also been shown to help with MASLD. The purpose of this study is to study how tirzepatide affects the liver in patients with MASLD. Participants will be asked to: * Take tirzepatide for 12 months. * Come in for clinic visits every 3 months. * Have blood drawn at baseline, 6, and 12 months. * Complete a liver ultrasound at baseline and at 12 months.
Interventions
DRUGTirzepatide
The drug is being studied to better understand the biological effects of tirzepatide on MASLD.
Sponsors
University of New Mexico
American Cancer Society, Inc.
University of New Mexico Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers associated with MASLD | 12 months | Identification of an changes in biomarkers associated with MASLD with tirzepatide use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver Fat Content | 12 months | Change in liver fat content with use of tirzepatide |
| Liver Stiffness | 12 months | Change in liver stiffness with use of tirzepatide |
| Body weight | 12 months | Change in body weight with use of tirzepatide |
| Metabolic markers | 12 months | Changes in lipid profiles, glycemic measures (A1c), inflammatory markers and cytokines, and gut hormones |
Countries
United States
Contacts
CONTACTKristen Gonzales, MD
PRINCIPAL_INVESTIGATOREliseo Castillo
UNM Cancer Center
Outcome results
None listed