A study testing whether a new weekly shot from Regeneron Pharmaceuticals, tirzepatide, can improve fatty liver disease.
- Who can join
- Adults 18 to 75, have fatty liver disease (also called MASH or NASH), BMI 30+.
- 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 3.8 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).
Full scientific study title: A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD.
Who can join
Adults 18 to 75, have fatty liver disease (also called MASH or NASH), BMI 30+. 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
- Homozygous for the PNPLA3 p.I148M genotype
- Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) >=15% at visit 3
- Has a Body Mass Index (BMI) >=30 to <45 kg/m^2 at visit 2
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <=3 × Upper Limit of Normal (ULN) as described in the protocol
- On a stable dose of tirzepatide at randomization (>=5 mg weekly)
Key exclusion criteria
- Evidence or diagnosis of portal hypertension or cirrhosis from any cause, including cirrhosis due to MASH, as determined by the investigator, based on medical history, clinical assessment, imaging, and/or liver biopsy
- Known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol
- Contraindications to MRI examinations, including but not limited to persons with MRI-incompatible cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions
- Any contraindication listed in the Zepbound United States Prescribing Information (USPI), as defined in the protocol
Where this study is enrolling
This trial has 5 sites across 3 states. Contact a site coordinator directly to start screening.
California2 sites
- Southern California Research CenterCoronado, California
- California Liver Research InstitutePasadena, California
Louisiana1 site
- Tandem Clinical Research, Plaza IIMetairie, Louisiana
Texas2 sites
- Advanced Medical TrialsGeorgetown, Texas
- American Research Corporation at The Texas Liver InstituteSan Antonio, Texas
Timeline
Started enrolling: 2026-05-22. Expected completion: 2030-03-15. Last updated on ClinicalTrials.gov: 2026-06-26.
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:
Other GLP-1 clinical trials
Back to the full directory → or take the matching quiz if you want clinical trials filtered to your conditions and location.
