Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06934642

Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

MASLD Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location status: Recruiting

Location contact

Eliseo Castillo, PhD

PRINCIPAL_INVESTIGATOR

Kristen Gonzales, MD

CONTACT

[email protected]

505-272-3840

Kristen Gonzales, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

The drug is being studied to better understand the biological effects of tirzepatide on MASLD.

Other names: Zepbound, Mounjaro

Primary outcomes

  1. Biomarkers associated with MASLD

    Time frame: 12 months

    Identification of an changes in biomarkers associated with MASLD with tirzepatide use

Secondary outcomes

  1. Liver Fat Content

    Time frame: 12 months

    Change in liver fat content with use of tirzepatide

  2. Liver Stiffness

    Time frame: 12 months

    Change in liver stiffness with use of tirzepatide

  3. Body weight

    Time frame: 12 months

    Change in body weight with use of tirzepatide

  4. Metabolic markers

    Time frame: 12 months

    Changes in lipid profiles, glycemic measures (A1c), inflammatory markers and cytokines, and gut hormones

Study contacts

Contact information is provided by the study sponsor or research team.

Kristen Gonzales, MD

CONTACT

[email protected]

15052723840

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • American Cancer Society, Inc.
  • University of New Mexico Cancer Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.