Status:
RECRUITING
Effect of Tirzepatide on Markers of MASLD in Patients With Obesity
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
American Cancer Society, Inc.
University of New Mexico Cancer Center
Conditions:
MASLD
Obesity
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06934642
Start Date
June 30 2025
End Date
August 1 2026
Last Update
July 14 2025
Active Locations (1)
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1
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131