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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

StatusRecruiting
PhasePhase 2
Started2026-05-22
View on ClinicalTrials.gov ↗

Amendment history

2026-09-30
Trial sites expanded: 6 → 9 locations
2026-08-06
Study Status, Contacts/Locations v2
Study sites5→6
2026-06-23
Study Status, Outcome Measures, Eligibility, Contacts/Locations v1
Recruitment opened
Trial sites expanded: 0 → 5 locations
Primary completion pushed: 2029-11-27 → 2030-03-15
Completion pushed: 2029-11-27 → 2030-03-15
Start dateestimated 2026-04-20→confirmed 2026-05-22
Eligibility criteria-1 characters
[...] ize restrictions Any contraindication listed in the Zepbound® United States Prescribing Information (USPI), as defined in [...]
Secondary endpoints3 entries, revised
OccurenceOccurrence of Treatment-Emergent Adverse Events (TEAEs)
2026-04-07
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
NASH / MASH
645 trials monitored
See 22 trials at risk
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
Trial Details
NCT Number NCT07527910
Lead Sponsor Regeneron Pharmaceuticals
Conditions Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Enrollment 204 participants
Start Date 2026-05-22
Primary Completion 2030-03-15 (estimated)
Study Completion 2030-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-29