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

NCT07527910 · Not yet recruiting

Last updated 2026-05-28

This clinical trial is testing a new medication called ALN-PNP in adults with a specific liver condition (MASLD) caused by a genetic mutation, both with and without another diabetes medication (GLP1R agonist).

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 204 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2026-04 · est. completion 2029-11

What this study is testing ClinicalTrials.gov NCT07527910 ↗

Description as written by the study sponsor.

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

Treatments tested

ALN-PNP Drug

Administered per the protocol
Tirzepatide also known as Zepbound® Drug

Administered per the protocol
Placebo Drug

Administered per the protocol Placebo matching ALN-PNP

Main thing measured	Percent change in liver fat
Sponsor	Regeneron Pharmaceuticals
Conditions studied	Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07527910 ↗