A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: liver
- Who it enrolls
- age 18 Years to 75 Years; BMI ≥30 required; conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- Interventions
- ALN-PNP; Tirzepatide; Placebo
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- Phase and size
- Phase 2 · 204 participants
- Dates
- Start 2026-05-22
Primary completion 2030-03-15 - Sponsor
- Regeneron Pharmaceuticals (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Percent change in liver fatFrom baseline at week 24
- Percent change in liver fatFrom baseline at week 48
02Eligibility
Who can take part
Key Inclusion Criteria: Part A and Part B: 1. Homozygous for the PNPLA3 p.I148M genotype 2. Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥15% at visit 3 3. Has a Body Mass Index (BMI) ≥30 to \<45 kg/m\^2 at visit 2 Part A: To be eligible for randomization on study day 1: 1. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3 × Upper Limit of Normal (ULN) as described in the protocol 2. On a stable dose of tirzepatide at randomization (≥5 mg weekly) Key Exclusion Criteria: 1. Evidence or diagnosis of portal hypertension or cirrhosis from any cause, including cirrhosis due to MASH, as determined by the investigator, based on medical history, clinical assessment, imaging, and/or liver biopsy 2. Known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol 3. Contraindications to MRI examinations, including but not limited to persons with MRI-incompatible cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions 4. Any contraindication listed in the Zepbound United States Prescribing Information (USPI), as defined in the protocol NOTE: Other protocol-defined inclusion/exclusion criteria apply.
03Change log
Registry changes
No changes recorded since the trial was added.