Current partner codePEPTIDESDE
NCT06934642·Early Phase 1·INTERVENTIONAL

Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

Status

Recruiting

Phase

Early Phase 1

Enrollment

8

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Tirzepatide

The drug is being studied to better understand the biological effects of tirzepatide on MASLD.

Timeline

From registration to results.

  1. First posted

    Apr 18, 2025

  2. Study start

    Jun 30, 2025

  3. Primary completion

    Aug 2026

  4. Study completion

    Aug 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 15, 2026

Outcomes

What the study measures.

Primary outcomes

Biomarkers associated with MASLD

Time frame · 12 months

Identification of an changes in biomarkers associated with MASLD with tirzepatide use

Secondary outcomes

Liver Fat Content

Time frame · 12 months

Change in liver fat content with use of tirzepatide

Liver Stiffness

Time frame · 12 months

Change in liver stiffness with use of tirzepatide

Body weight

Time frame · 12 months

Change in body weight with use of tirzepatide

Metabolic markers

Time frame · 12 months

Changes in lipid profiles, glycemic measures (A1c), inflammatory markers and cytokines, and gut hormones

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

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