NCT06934642 Effect of Tirzepatide on Markers of MASLD in Patients With Obesity
| NCT ID | NCT06934642 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of New Mexico |
| Condition | MASLD |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2025-06-30 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Eliseo Castillo
PRINCIPAL INVESTIGATOR
UNM Cancer Center
Frequently Asked Questions
Who can join the NCT06934642 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying MASLD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06934642 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06934642 currently recruiting?
Yes, NCT06934642 is actively recruiting participants. Contact the research team at KrGonzales@salud.unm.edu for enrollment information.
Where is the NCT06934642 trial being conducted?
This trial is being conducted at Albuquerque, United States.
Who is sponsoring the NCT06934642 clinical trial?
NCT06934642 is sponsored by University of New Mexico. The principal investigator is Eliseo Castillo at UNM Cancer Center. The trial plans to enroll 8 participants.