Recruiting
Early Phase 1

Tirzepatide

Sponsor:

University of New Mexico

Code:

NCT06934642

Conditions

MASLD

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

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.

Conditions

MASLD

Obesity

Study ID

NCT06934642

Start date

Jun 30, 2025

Status verified date

Sep, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

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

Interventions

Tirzepatide

The drug is being studied to better understand the biological effects of tirzepatide on MASLD.

Primary outcome measure

  • Biomarkers associated with MASLD [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Kristen Gonzales, MD

15052723840KrGonzales@salud.unm.edu

Locations

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Kristen Gonzales, MD

505-272-3840KrGonzales@salud.unm.edu

Principal Investigator:

Kristen Gonzales, MD

More Information

Sponsor

University of New Mexico

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-09-04.