Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT06934642

Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

Led by University of New Mexico · Updated on 2025-07-14

8

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

Sponsors

U

University of New Mexico

Lead Sponsor

A

American Cancer Society, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women
  • Age between 18 and 75 years
  • Diagnosis of MASLD with at least one of the following cardiometabolic criteria:
  • BMI greater than 25 kg/m2 or waist circumference over 94 cm for men or 80 cm for women
  • Fasting glucose over 100 mg/dL, 2-hour post-meal glucose over 140 mg/dL, A1c over 5.7%, type 2 diabetes, or treatment for type 2 diabetes
  • Blood pressure over 130/85 mmHg or on antihypertensive treatment
  • Triglycerides over 150 mg/dL or on lipid-lowering treatment
  • HDL cholesterol less than 40 mg/dL in men or less than 50 mg/dL in women or on lipid-lowering medication
  • No other identified causes of liver fat accumulation
  • Evidence of fatty liver disease by imaging or biopsy
  • Able to speak English
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Premenopausal women not using contraception
  • Alcohol intake over 50g/day or 350g/week for women, over 60g/day or 420g/week for men, or AUDIT score over 8
  • Other known causes of liver fat accumulation
  • Allergic reaction to tirzepatide or other GLP-1 receptor agonists
  • Decompensated liver disease
  • Decompensated kidney disease needing hemodialysis
  • Decompensated heart failure
  • Active cancer
  • History of pancreatitis
  • Triglyceride levels over 500 mg/dL
  • Personal or family history of medullary thyroid cancer or MEN2a or MEN2b
  • Use of other anti-obesity medications
  • Use of other GLP-1 receptor agonists within 3 months before joining
  • Unable to get the medication due to cost or insurance restrictions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

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Research Team

K

Kristen Gonzales, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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