RecruitingPhase 2NCT07527910

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

A Two-Part, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of ALN-PNP With and Without a GLP1R Agonist in Adults With Homozygous PNPLA3-Related Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)


Sponsor

Regeneron Pharmaceuticals

Enrollment

204 participants

Start Date

May 22, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ALN-PNP, a drug called Placebo, and others for people with metabolic dysfunction–associated steatotic liver disease (masld). The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALN-PNP

Administered per the protocol

DRUGTirzepatide

Administered per the protocol

DRUGPlacebo

Administered per the protocol Placebo matching ALN-PNP


Locations(5)

Southern California Research Center

Coronado, California, United States

California Liver Research Institute

Pasadena, California, United States

Tandem Clinical Research, Plaza II

Metairie, Louisiana, United States

Advanced Medical Trials

Georgetown, Texas, United States

American Research Corporation at The Texas Liver Institute

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07527910


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