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Clinical Trials in the USA / NCT07527910
Recruiting Phase 2

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

NCT07527910 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 2
Started
2026-05-22
Last updated
2026-09-29

Condition(s) studied

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Investigational drug(s) / intervention(s)

ALN-PNP →Tirzepatide →Placebo

ALN-PNP: Administered per the protocol

Tirzepatide: Administered per the protocol

Placebo: Administered per the protocol Placebo matching ALN-PNP

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percent change in liver fat — From baseline at week 24
    Part A
  • Percent change in liver fat — From baseline at week 48
    Part B

Trial sites (9)

FacilityCityRegionStatus
Arizona Liver Health - Tucson Tucson Arizona Recruiting
Southern California Research Center Coronado California Recruiting
California Liver Research Institute Pasadena California Recruiting
Health Awareness, Inc Jupiter Florida Recruiting
Evolution Clinical Trials Miami Florida Recruiting
Tandem Clinical Research, Plaza II Metairie Louisiana Recruiting
American Research Corporation Austin Texas Recruiting
Advanced Medical Trials Georgetown Texas Recruiting
American Research Corporation at The Texas Liver Institute San Antonio Texas Recruiting

On this site

📄 Mounjaro (tirzepatide) drug profile →

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Other trials for the same condition

A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07527910 on ClinicalTrials.gov ↗ ← All trials in the USA