Clinical trial NCT06934642: Effect of Tirzepatide on Markers of MASLD in Patients With Obesity
Official title: Effect of Tirzepatide on Markers of MASLD in Patients With Obesity: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: MASLD
Obesity
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: University of New Mexico Cancer Center
First posted: 2025-04-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Biomarkers associated with MASLD
timeFrame: 12 months
Secondary outcomes:
measure: Liver Fat Content
timeFrame: 12 months
measure: Liver Stiffness
timeFrame: 12 months
measure: Body weight
timeFrame: 12 months
measure: Metabolic markers
timeFrame: 12 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
Study officials:
affiliation: UNM Cancer Center
name: Eliseo Castillo
role: PRINCIPAL_INVESTIGATOR
References: