Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

Early Phase 1

Recruiting

• Conditions: MASLD; Obesity
• Interventions: Drug: Tirzepatide

• Registration Number: NCT06934642
• Lead Sponsor: University of New Mexico

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Study Start: 2025-05
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Tirzepatide	Individuals in the intervention arm (only arm) will receive tirzepatide for 12 months.

Primary Outcome Measures

Name	Time	Method
Biomarkers associated with MASLD	12 months	Identification of an changes in biomarkers associated with MASLD with tirzepatide use

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States