Effect of Tirzepatide on Markers of MASLD in Patients With Obesity
NCT ID: NCT06934642
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
8 participants
INTERVENTIONAL
2025-06-30
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Intervention Arm
Individuals in the intervention arm (only arm) will receive tirzepatide for 12 months.
Tirzepatide
The drug is being studied to better understand the biological effects of tirzepatide on MASLD.
Interventions
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Tirzepatide
The drug is being studied to better understand the biological effects of tirzepatide on MASLD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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American Cancer Society, Inc.
OTHER
University of New Mexico Cancer Center
OTHER
University of New Mexico
OTHER
Responsible Party
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Principal Investigators
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Eliseo Castillo
Role: PRINCIPAL_INVESTIGATOR
UNM Cancer Center
Locations
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University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25-072
Identifier Type: -
Identifier Source: org_study_id
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