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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tirzepatide on Markers of MASLD in Patients With Obesity: A Pilot Study
- ClinicalTrials.gov ID
- NCT06934642
- Acronym / sponsor ID
- 25-072
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., University of New Mexico Cancer Center
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: TirzepatideIndividuals in the intervention arm (only arm) will receive tirzepatide for 12 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women
- Age 18-75
- Diagnosis of MASLD based on the following 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: Zepbound, MounjaroThe drug is being studied to better understand the biological effects of tirzepatide on MASLD. | Drug | Intervention Arm |
Primary outcome
Biomarkers associated with MASLD
Time frame: 12 months
Identification of an changes in biomarkers associated with MASLD with tirzepatide use
4 secondary outcomes
Liver Fat Content
Time frame: 12 months
Liver Stiffness
Time frame: 12 months
Body weight
Time frame: 12 months
Metabolic markers
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers. Data will only be available to study team members.
Related trials for MASLD
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NAFLD Clinical Care Pathway
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eliseo Castillo principal investigator
UNM Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen Gonzales, MD (15052723840, KrGonzales@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers associated with MASLD (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.