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

Part of paid clinical trials in Coronado, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07527910
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ALN-PNP — DRUG
    Administered per the protocol
  • Tirzepatide — DRUG
    Administered per the protocol
  • Placebo — DRUG
    Administered per the protocol Placebo matching ALN-PNP

Study Details

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

Key Dates

First listed
Apr 14, 2026
Start date
May 22, 2026
Status verified
Jun 2026
Primary completion
Mar 15, 2030
Completion
Mar 15, 2030

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: A1
  • Experimental: Part A: A2
  • Experimental: Part B: B1
  • Experimental: Part B: B2
  • Experimental: Part B: B3
  • Placebo Comparator: Part B: B4

Primary Outcome Measure

Percent change in liver fat [ Time Frame: From baseline at week 24 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Southern California Research CenterCoronadoCalifornia92118-
California Liver Research InstitutePasadenaCalifornia91105-
Tandem Clinical Research, Plaza IIMetairieLouisiana70006-
Advanced Medical TrialsGeorgetownTexas78628-
American Research Corporation at The Texas Liver InstituteSan AntonioTexas78215-

Find similar trials in Coronado, CA

By research site
Southern California Research Center· Coronado, CACalifornia Liver Research Institute· Pasadena, CATandem Clinical Research, Plaza II· Metairie, LAAdvanced Medical Trials· Georgetown, TXAmerican Research Corporation at The Texas Liver Institute· San Antonio, TX

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