A Study of STX-1150 in Participants With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
Recruiting · NCT07428473 · Interventional (participants receive a specific treatment) · Lead sponsor: Monash University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
STX-1150 is an investigational therapy designed to lower LDL-C by silencing a gene called PCSK9 in the liver. STX-1150 does not edit or permanently change the gene. STX-1150 comprises an mRNA and guide RNA (gRNA) delivered via lipid nanoparticles (LNP) for intravenous infusion. The mRNA produces a protein that switches off the PCSK9 gene expression without altering the DNA sequence. This process leverages natural mechanisms that regulate gene activity. The study will enroll up to 64 participants with elevated LDL-C across sites in Australia and New Zealand. The follow-up period will be up to 1- year post-treatment.
Who can take part
Inclusion criteria
- Elevated serum LDL-C with or without LDL-C lowering medication
- Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures
Exclusion criteria
- Patients with history of an ASCVD event \</= 6 months.
- Any uncontrolled or serious disease, or any medical or surgical condition that may interfere with participation
- Diagnosis of familial hypercholesterolemia
- Active or history of liver disease
- Previous treatment with PCSK9-inhibitor or other prior treatment within a specified timeframe
- Clinically significant abnormal laboratory values
Where it is running
2 locations listed.
- New Zealand Clinical Research (NZCR) - Christchurch, Christchurch, New Zealand
- Monash Health/ Victorian Heart Hospital (VHH) - Clayton, Victoria, Australia