Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; MASLD
• Intervention / Treatment: Drug: Tirzepatide

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Kristen Gonzales, MD; Phone Number: 15052723840; Email: KrGonzales@salud.unm.edu

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Recruiting
      • University of New Mexico Health Sciences Center
      • Contact: Kristen Gonzales, MD; Phone Number: 505-272-3840; Email: KrGonzales@salud.unm.edu
      • Principal Investigator: Kristen Gonzales, MD
      • Principal Investigator: Eliseo Castillo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Individuals in the intervention arm (only arm) will receive tirzepatide for 12 months.	Drug: Tirzepatide; The drug is being studied to better understand the biological effects of tirzepatide on MASLD.; Other Names: Mounjaro; Zepbound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers associated with MASLD	Identification of an changes in biomarkers associated with MASLD with tirzepatide use	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Fat Content	Change in liver fat content with use of tirzepatide	12 months
Liver Stiffness	Change in liver stiffness with use of tirzepatide	12 months
Body weight	Change in body weight with use of tirzepatide	12 months
Metabolic markers	Changes in lipid profiles, glycemic measures (A1c), inflammatory markers and cytokines, and gut hormones	12 months

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: American Cancer Society, Inc.; University of New Mexico Cancer Center
• Investigators: Principal Investigator: Eliseo Castillo, UNM Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: 25-072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers. Data will only be available to study team members.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes