Health TrialsbyHealthPanel

Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

ConditionsMASLDObesity
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of New Mexico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women

Age 18-75

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Tirzepatide

    Drug

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

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: Intervention ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Biomarkers associated with MASLD

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

Time frame
12 months

Secondary outcomes

1

Liver Fat Content

Change in liver fat content with use of tirzepatide

Time frame
12 months
2

Liver Stiffness

Change in liver stiffness with use of tirzepatide

Time frame
12 months
3

Body weight

Change in body weight with use of tirzepatide

Time frame
12 months
4

Metabolic markers

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of New Mexico

Lead sponsor

American Cancer Society, Inc.

Collaborator

University of New Mexico Cancer Center

Collaborator

Source ClinicalTrials.gov
Apply now