NCT06934642RecruitingEarly phase 1
Effect of Tirzepatide on Markers of MASLD in Patients With Obesity
Effect of Tirzepatide on Markers of MASLD in Patients With Obesity: A Pilot Study
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 11 Apr 2025
- Start date
- 30 Jun 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- University of New Mexico
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06934642
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 8
- From 30 Jun 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of pancreatitis
- Concurrent use of other ant-obesity medications
- Unable to obtain the medication due to cost or insurance coverage restrictions.
Other illness
- Documented allergic reaction to tirzepatide or any other GLP1 RA
- Decompensated liver disease
- Decompensated renal disease requiring hemodialysis
- Decompensated heart failure
- Active malignancy
- Personal or family history of medullary thyroid cancer or MEN2a or MEN2b
Lab values
- Serum triglyceride levels \>500 mg/dL
Other
- 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
- Use of other GLP1 RAs within 3 months of study enrollment
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Mexico Health Sciences Center Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.