A Phase 2 interventional study of ALN-PNP and Tirzepatide in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), sponsored by Regeneron Pharmaceuticals. Recruiting at 9 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
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:
Key Inclusion Criteria:
Part A and Part B:
Part A: To be eligible for randomization on study day 1:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria apply.
Drug: ALN-PNP · Drug: Tirzepatide
Drug: Tirzepatide · Drug: Placebo
Drug: ALN-PNP · Drug: Tirzepatide
Drug: Tirzepatide · Drug: Placebo
Drug: ALN-PNP
Drug: Placebo
Administered per the protocol
Administered per the protocol
Also known as: Zepbound®
Administered per the protocol Placebo matching ALN-PNP
Percent change in liver fat
Part A
Time frame: From baseline at week 24
Percent change in liver fat
Part B
Time frame: From baseline at week 48
Achievement of liver fat <5%
Time frame: At weeks 24 and 48
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through week 72
Severity of TEAEs
Time frame: Through week 72
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
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Non-alcoholic Fatty Liver Disease→
Regeneron Pharmaceuticals