Recruiting
Phase 2

ALN-PNP with Tirzepatide

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07527910

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALN-PNP

Tirzepatide

Placebo

Study Details

Brief 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

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Study ID

NCT07527910

Start date

May 22, 2026

Status verified date

Aug, 2026

Completion date

Mar 15, 2030

Anticipated

Primary completion date

Mar 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

ALN-PNP

Administered per the protocol

Tirzepatide

Administered per the protocol

Placebo

Administered per the protocol Placebo matching ALN-PNP

Primary outcome measure

  • Percent change in liver fat [ Time Frame: From baseline at week 24 ]
  • Percent change in liver fat [ Time Frame: From baseline at week 48 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Southern California Research Center

Recruiting

Coronado, California, United States, 92118

California Liver Research Institute

Recruiting

Pasadena, California, United States, 91105

Tandem Clinical Research, Plaza II

Recruiting

Metairie, Louisiana, United States, 70006

American Research Corporation

Recruiting

Austin, Texas, United States, 78757

Advanced Medical Trials

Recruiting

Georgetown, Texas, United States, 78628

American Research Corporation at The Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Homozygous PNPLA3-Related MASLD
  • Fatty Liver Disease
  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)
  • Non-Alcoholic Fatty Liver Disease (NAFLD)
  • Nonalcoholic Steatohepatitis (NASH)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-10.