Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

NCT ID: NCT06934642

Last Updated: 2025-07-14

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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MASLD Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Arm

Individuals in the intervention arm (only arm) will receive tirzepatide for 12 months.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Zepbound Mounjaro

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

University of New Mexico Cancer Center

OTHER

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristen Gonzales, MD

Role: CONTACT

15052723840

Facility Contacts

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Kristen Gonzales, MD

Role: primary

505-272-3840

Other Identifiers

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25-072

Identifier Type: -

Identifier Source: org_study_id

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