Tirzepatide's effect on liver health in obese patients

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

This study tests if tirzepatide can improve liver health in obese patients who have a condition called MASLD.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of New Mexico (Academic / other)
• Locations: 1 site (Albuquerque, New Mexico)
• Trial ID: NCT06934642 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of tirzepatide, a medication used for treating type 2 diabetes and obesity, on markers of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in patients with obesity. Participants will take tirzepatide for 12 months and attend clinic visits every three months, during which blood samples will be collected and liver ultrasounds performed. The study aims to determine how tirzepatide influences liver health in individuals diagnosed with MASLD.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 18-75 with a diagnosis of MASLD and obesity or related cardiometabolic conditions.

Not a fit: Patients who are pregnant, breastfeeding, or have significant alcohol intake may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with MASLD, potentially improving liver health and overall metabolic function.

How similar studies have performed: While tirzepatide has shown promise in treating obesity and type 2 diabetes, its specific effects on MASLD are still being explored, making this approach relatively novel.

Eligibility criteria

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.

Where this trial is running

Albuquerque, New Mexico

• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (Recruiting)

Study contacts

• Principal investigator: Eliseo Castillo — UNM Cancer Center
• Study coordinator: Kristen Gonzales, MD

Conditions MASLD; Obesity