NCT06934642 · University of New Mexico
Effect of Tirzepatide on Markers of MASLD in Patients With Obesity
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Men and women
- 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
- Albuquerque, New Mexico
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2025 · Source of record for eligibility and locations