STX-1150, a Gene-Silencing Treatment, for Adults With High LDL Cholesterol
Tests STX-1150, which silences the PCSK9 gene, in adults with high LDL cholesterol.
Plain-language title generated from the registry record
Registry title: A Study of STX-1150 in Participants With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
Key facts
- Where
- Clayton, AustraliaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07428473, who can take part
Where in Australia
- Monash Health/ Victorian Heart Hospital (VHH)Clayton, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Monash University
- Trial code
- NCT07428473
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 1 Open-Label Single Ascending Dose (Part 1) and Single or Multi-Dose Expansion (Part 2) Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of STX-1150 in Participants With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
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.
Inclusion: 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: Previous treatment with PCSK9-inhibitor or other prior treatment within a specified timeframe; 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; Active or history of liver disease; Clinically significant abnormal laboratory values; Diagnosis of familial hypercholesterolemia.