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RECRUITING Phase 2 ClinicalTrials.gov

A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07527910

Registry updated: 2026-09-29
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Description

This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty liver disease. ALN-PNP reduces the amount of Patatin-like phospholipase domain-containing protein 3 (PNPLA3), a protein that liver cells make, which may help decrease liver fat if there is an abnormal PNPLA3 protein. The goal of this study is to understand the effect of ALN-PNP with or without tirzepatide on reducing liver fat. The study is looking at: * How well ALN-PNP with and without tirzepatide works * What side effects ALN-PNP might cause * How much ALN-PNP is in the blood at different times * How the body and the liver change after having ALN-PNP, which can help researchers understand why ALN-PNP works better in some people than others

Interventions

  • ALN-PNP (Drug)
    Administered per the protocol
  • Tirzepatide (Drug)
    Administered per the protocol
  • Placebo (Drug)
    Administered per the protocol Placebo matching ALN-PNP

Eligibility criteria

Key Inclusion Criteria: Part A and Part B: 1. Homozygous for the PNPLA3 p.I148M genotype 2. Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥15% at visit 3 3. Has a Body Mass Index (BMI) ≥30 to \<45 kg/m\^2 at visit 2 Part A: To be eligible for randomization on study day 1: 1. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3 × Upper Limit of Normal (ULN) as described in the protocol 2. On a stable dose of tirzepatide at randomization (≥5 mg weekly) Key Exclusion Criteria: 1. 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 2. Known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol 3. Contraindications to MRI examinations, including but not limited to persons with MRI-incompatible cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions 4. Any contraindication listed in the Zepbound United States Prescribing Information (USPI), as defined in the protocol NOTE: Other protocol-defined inclusion/exclusion criteria apply.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Locations

  • Arizona Liver Health - Tucson — Tucson, Arizona, United States
  • Southern California Research Center — Coronado, California, United States
  • California Liver Research Institute — Pasadena, California, United States
  • Health Awareness, Inc — Jupiter, Florida, United States
  • Evolution Clinical Trials — Miami, Florida, United States
  • Tandem Clinical Research, Plaza II — Metairie, Louisiana, United States
  • American Research Corporation — Austin, Texas, United States
  • Advanced Medical Trials — Georgetown, Texas, United States
  • American Research Corporation at The Texas Liver Institute — San Antonio, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record