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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention Arm 		Individuals in the intervention arm (only arm) will receive tirzepatide for 12 months.
  • Drug: Tirzepatide
    The drug is being studied to better understand the biological effects of tirzepatide on MASLD.
    Other names:
    • Zepbound
    • Mounjaro

Recruiting Locations

University of New Mexico Health Sciences Center
Albuquerque, New Mexico 87131
Contact:
Kristen Gonzales, MD
505-272-3840
KrGonzales@salud.unm.edu

More Details

Status
Recruiting
Sponsor
University of New Mexico

Study Contact

Kristen Gonzales, MD
15052723840
KrGonzales@salud.unm.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.