MASLDEarly Phase 1NCT06934642
Effect of Tirzepatide on Markers of MASLD in Patients With Obesity
A Early Phase 1 study testing Tirzepatide in people with MASLD and Obesity, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Tirzepatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to Oct 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Kristen Gonzales, MD, 505-272-3840, KrGonzales@salud.unm.edu
Kristen Gonzales, MD
About this study
Official title: Effect of Tirzepatide on Markers of MASLD in Patients With Obesity: A Pilot Study
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.
- Being tested
- Tirzepatide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Zepbound, Mounjaro
The drug is being studied to better understand the biological effects of tirzepatide on MASLD.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Individuals in the intervention arm (only arm) will receive tirzepatide for 12 months. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers associated with MASLD
Identification of an changes in biomarkers associated with MASLD with tirzepatide use
Measured: 12 months
Secondary outcomes (4)
Liver Fat Content
Change in liver fat content with use of tirzepatide
Measured: 12 months
Liver Stiffness
Change in liver stiffness with use of tirzepatide
Measured: 12 months
Body weight
Change in body weight with use of tirzepatide
Measured: 12 months
Metabolic markers
Changes in lipid profiles, glycemic measures (A1c), inflammatory markers and cytokines, and gut hormones
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start30 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., University of New Mexico Cancer Center
- Responsible party
- Sponsor
- Investigators
- Eliseo Castillo, Principal investigator, UNM Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934642
- Sponsor's protocol ID
- 25-072
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers. Data will only be available to study team members.