NCT07527910RecruitingPhase 2
A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD
A Two-Part, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of ALN-PNP With and Without a GLP1R Agonist in Adults With Homozygous PNPLA3-Related Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- 22 May 2026
- Primary completion date
- 15 Mar 2030
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07527910
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 204
- From 22 May 2026 to the primary completion date, 15 Mar 2030
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol
- Contraindications to MRI examinations, including but not limited to persons with MRI-incompatible cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions
Other
- Any contraindication listed in the Zepbound United States Prescribing Information (USPI), as defined in the protocol
- NOTE: Other protocol-defined inclusion/exclusion criteria apply.
Who the study is looking for
- Part A and Part B:
- Homozygous for the PNPLA3 p.I148M genotype
- Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥15% at visit 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:
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3 × Upper Limit of Normal (ULN) as described in the protocol
- On a stable dose of tirzepatide at randomization (≥5 mg weekly)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| American Research Corporation Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Southern California Research Center Coordinator of this site? Confirm its status | Coronado | United States | Recruiting |
| Advanced Medical Trials Coordinator of this site? Confirm its status | Georgetown | United States | Recruiting |
| Health Awareness, Inc Coordinator of this site? Confirm its status | Jupiter | United States | Recruiting |
| Tandem Clinical Research, Plaza II Coordinator of this site? Confirm its status | Metairie | United States | Recruiting |
| Evolution Clinical Trials Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| California Liver Research Institute Coordinator of this site? Confirm its status | Pasadena | United States | Recruiting |
| American Research Corporation at the Texas Liver Institute Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Arizona Liver Health - Tucson Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.