Actively Recruiting
Effect of Tirzepatide on Markers of MASLD in Patients With Obesity: A Pilot Study
Led by University of New Mexico · Updated on 2025-07-14
8
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of New Mexico
Lead Sponsor
A
American Cancer Society, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a common chronic liver condition that mostly affects people who are overweight, have obesity, type 2 diabetes, or cardiovascular disease. Researchers are studying how tirzepatide, a medication used for type 2 diabetes and obesity, affects the liver in patients with MASLD. This study is an early phase 1 clinical trial aiming to understand the biological effects of tirzepatide on MASLD markers. Participants will take tirzepatide for 12 months as part of an intervention arm. They will attend clinic visits every 3 months during this time. Blood samples will be collected at the start, 6 months, and 12 months to monitor changes. Liver ultrasounds will be performed at the beginning and end of the study to assess liver health. During the study, researchers will measure biomarkers associated with MASLD, liver fat content, liver stiffness, body weight, and metabolic markers over the 12-month period. Participants will have regular check-ups to track these outcomes and monitor safety. The total study duration for each participant is one year.
CONDITIONS
Brief Title
Effect of Tirzepatide on Markers of MASLD in Patients With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women
- Age 18 to 75 years
- Diagnosis of MASLD with at least one of these cardiometabolic criteria: BMI over 25 kg/m2 or waist circumference over 94 cm (men) or 80 cm (women)
- Elevated fasting serum glucose over 100 mg/dL, 2-hour post-prandial glucose over 140 mg/dL, HbA1c over 5.7%, type 2 diabetes, or treatment for type 2 diabetes
- Blood pressure over 130/85 mmHg or on antihypertensive treatment
- Plasma triglycerides over 150 mg/dL or on lipid-lowering treatment
- Plasma HDL-cholesterol below 40 mg/dL (men) or below 50 mg/dL (women) or on lipid-lowering medication
- No other identified causes of steatosis
- Evidence of steatotic liver disease by imaging or biopsy
- English speaking
You will not qualify if you...
- Pregnancy or breastfeeding
- Premenopausal women not using any contraception
- Alcohol intake above 50 g/day or 350 g/week for women, above 60 g/day or 420 g/week for men, or AUDIT score above 8
- Other identifiable causes of steatosis
- Allergic reaction to tirzepatide or other GLP-1 receptor agonists
- Decompensated liver disease
- Decompensated renal disease requiring hemodialysis
- Decompensated heart failure
- Active cancer
- Prior history of pancreatitis
- Serum triglyceride levels above 500 mg/dL
- Personal or family history of medullary thyroid cancer or MEN2a or MEN2b
- Use of other anti-obesity medications
- Use of other GLP-1 receptor agonists within 3 months before enrollment
- Unable to access medication due to cost or insurance coverage restrictions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive tirzepatide to study its biological effects on MASLD.
Regular visits during the 12 months of treatment
Trial Site Locations
Total: 1 location
1
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
Research Team
K
Kristen Gonzales, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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