How different chemical versions of LEQVIO (inclisiran) change its effects
Comprehensive assessment of the diastereomer composition of LEQVIO (Inclisiran) to determine how chemical synthesis impacts biological activity
This project looks at whether different chemical forms created during LEQVIO (inclisiran) manufacturing change how well the medicine works for people with high LDL cholesterol.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Maryland Baltimore NIH-funded |
| Lab location | 1 site (Baltimore, United States) |
| Project ID | NIH-11178623 on NIH RePORTER |
What this research studies
You would hear how researchers are mapping the specific chemical forms (diastereomers) that appear when inclisiran is synthesized. They will study how those different forms affect stability, protein interactions, delivery to the liver, and the drug's ability to lower PCSK9 and LDL using chemical analysis and lab-based biological tests. The work will compare different manufacturing batches and may use cell-based systems or biological samples to link chemistry to activity. The goal is to find whether tighter control of these chemical variants could make the medicine more consistent and safer for patients.
Who could benefit from this research
Good fit: Adults with elevated LDL cholesterol who are receiving or are eligible for inclisiran (LEQVIO) and willing to provide samples or clinical information would be the most relevant participants.
Not a fit: People who are not treated with inclisiran or whose cholesterol is managed exclusively by other therapies are unlikely to directly benefit from this project.
Why it matters
Potential benefit: If successful, this work could lead to more consistent, effective, and safer inclisiran dosing for people treated to lower LDL cholesterol.
How similar studies have performed: Studies on related oligonucleotide drugs have shown that diastereomer composition can change activity, but applying this detailed analysis specifically to inclisiran is relatively new.
Where this research is happening
Baltimore, United States
- University of Maryland Baltimore — Baltimore, United States (Active)
Researchers
- Principal investigator: Jones, Jace W — University of Maryland Baltimore
- Study coordinator: Jones, Jace W
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.