A study testing whether a new weekly shot from Ali Aminian, tirzepatide, can improve fatty liver disease.
- Who can join
- Adults 18 to 75, have fatty liver disease (also called MASH or NASH) with liver scarring (fibrosis), BMI 35+.
- What you take
- tirzepatide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
- How long it lasts
- The full study runs about 5.4 years; your own time in it is usually shorter.
- What you get
- The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
What this study is for
Primary condition: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD). Also studied in: Non-Alcoholic Fatty Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis (MASH), Liver Fibrosis, Obesity.
Full scientific study title: Fibrosis Lessens After Metabolic Surgery.
Who can join
Adults 18 to 75, have fatty liver disease (also called MASH or NASH) with liver scarring (fibrosis), BMI 35+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.
Full medical eligibility (for you and your doctor)verbatim from the registry
This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.
Key inclusion criteria
- Is a candidate for general anesthesia
- Is eligible for metabolic surgery (RYGB or SG) based on the ASMBS/IFSO 2022 guidelines
- Has insurance coverage for metabolic surgery (the requirements may vary in each country)
- Is >=18 and <=75 years old at the time of signing the informed consent
- Has a BMI >=35 and <=70 kg/m2 at the time of first study visit
Key exclusion criteria
- Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic):
- Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg)
- Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA (in case the screening test for hepatitis C is positive, the confirmative test is decisive)
- Autoimmune liver disease as diagnosed by antibodies or compatible liver histology
- Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts)
Where this study is enrolling
This trial has 4 sites across 4 states. Contact a site coordinator directly to start screening.
Arizona1 site
- Banner Health CenterPhoenix, ArizonaFarah Husain, MDFarah.husain@bannerhealth.com
Indiana1 site
- Indiana UniversityIndianapolis, IndianaDimitrios Stefanidis, MD, PhDdstefanidis@iuhealth.org
Minnesota1 site
- Mayo ClinicRochester, MinnesotaOmar Ghanem, MDghanem.omar@mayo.edu
Ohio1 site
- Cleveland ClinicCleveland, OhioAli Aminian, MDaminiaa@ccf.org
Timeline
Started enrolling: 2024-07-11. Expected completion: 2029-12-31. Last updated on ClinicalTrials.gov: 2025-08-22.
Official source
We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:
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