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

NCT07527910 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-04-14

No results posted yet for this study

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

Conditions

  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Interventions

DRUG

ALN-PNP

Administered per the protocol

DRUG

Tirzepatide

Administered per the protocol

DRUG

Placebo

Administered per the protocol Placebo matching ALN-PNP

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2029-11-27
Completion
2029-11-27
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07527910 on ClinicalTrials.gov