RECRUITING

Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Tirzepatide on Markers of MASLD in Patients With Obesity: A Pilot Study

Quick Facts

Study Start:2025-05

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06934642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Kristen Gonzales, MD

CONTACT

15052723840

KrGonzales@salud.unm.edu

Principal Investigator

Eliseo Castillo

PRINCIPAL_INVESTIGATOR

UNM Cancer Center

Study Locations (Sites)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131

United States

Collaborators and Investigators

Sponsor: University of New Mexico

Eliseo Castillo, PRINCIPAL_INVESTIGATOR, UNM Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-05

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

MASLD
Obesity