Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

ConditionsMASLDObesity
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of New Mexico

About this trial

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 criteria

Qualifiers

Men and women

Age 18-75

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tirzepatide

Treatment groups

8 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of New Mexico

Lead sponsor

American Cancer Society, Inc.

Collaborator

University of New Mexico Cancer Center

Collaborator