A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD (NCT07527910)
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)
๐ฉบ Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Southern California Research Center โ Coronado, California
Age range: 18 Years to 75 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (6 Sites)
- Southern California Research Center โ Coronado, California
- California Liver Research Institute โ Pasadena, California
- Tandem Clinical Research, Plaza II โ Metairie, Louisiana
- American Research Corporation โ Austin, Texas
- Advanced Medical Trials โ Georgetown, Texas
- American Research Corporation at The Texas Liver Institute โ San Antonio, Texas
๐ Contact the Study Coordinator
Phone: (844) 734-6643
Email: clinicaltrials@regeneron.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- Isocaloric Navy-Bean Substitution in Adults With MASLD โ New York, New York
- Fibrosis Lessens After Metabolic Surgery โ Phoenix, Arizona
- Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver. โ Sherbrooke, Quebec
Explore by condition: All Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.