Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

University of New Mexico (UNM)

Status and phase: Enrolling; Early Phase 1

Conditions: Obesity; MASLD

Treatments: Drug: Tirzepatide

Study type: Interventional

Funder types: Other

Identifiers

NCT06934642

25-072

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Intervention Arm

Experimental group

Description:

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

Treatment:

Drug: Tirzepatide