RecruitingPhase EARLY_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

Lead sponsor

University of New Mexico

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Eligibility highlights

•BMI ≥25

Primary endpoint

•Biomarkers associated with MASLD

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06934642

Org study ID25-072

Timeline

Milestones

Study first posted2025-04-18actual

Study start2025-06-30actual

Last update posted2025-07-14actual

Primary completion2026-08estimated (month precision)

Study completion2026-08estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver

Weight & body composition

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Body weight

Time frame:12 months

Body weight, absolute change (kg)

change from baseline, improvement

MASH / liver

3 endpoints

Primary/protocol endpoint/low confidence

Biomarkers associated with MASLD

Time frame:12 months

descriptive, improvement

Secondary/protocol endpoint

Liver Fat Content

Time frame:12 months

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Liver Stiffness

Time frame:12 months

Liver stiffness (VCTE), change

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Metabolic markers

Time frame:12 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.