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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
New Mexico
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
Contact Information
Primary
Kristen Gonzales, MD
KrGonzales@salud.unm.edu
15052723840
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2026-08
Participants
Target number of participants: 8
Treatments
Experimental: Intervention Arm
Individuals in the intervention arm (only arm) will receive tirzepatide for 12 months.
Related Therapeutic Areas
Sponsors
Leads: University of New Mexico
Collaborators: University of New Mexico Cancer Center, American Cancer Society, Inc.

This content was sourced from clinicaltrials.gov