Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

NCT06934642 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 25-072
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

MASLD; Obesity

Outcome Measures

Primary Outcomes (1)

• Biomarkers associated with MASLD

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

  12 months

Secondary Outcomes (4)

• Liver Fat Content

  12 months

• Liver Stiffness

  12 months

• Body weight

  12 months

• Metabolic markers

  12 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

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

Also known as: Zepbound, Mounjaro

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Eliseo Castillo

  UNM Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Gonzales, MD

CONTACT

15052723840; KrGonzales@salud.unm.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)