STX-1150 to lower LDL cholesterol in people with high LDL-C
Official title: 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)
Run by Monash University · NCT07428473 · Data updated 2026-11-12
This study tests STX-1150, an injectable therapy that silences the PCSK9 gene in the liver to lower LDL-C in adults with high LDL-C.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Monash University Academic / other |
| Locations | 3 sites (Clayton, Victoria and 2 other locations) |
| Status | Recruiting |
| Started | June 30, 2026 |
| Main results expected | December 30, 2028 |
| Study ends | December 30, 2028 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07428473 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates have elevated LDL-C, are willing to consent, and can comply with study procedures.
✕Probably not a fit
Patients with recent ASCVD events, significant liver disease, familial hypercholesterolemia, or prior PCSK9 inhibitor treatment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
STX-1150 uses mRNA and guide RNA delivered in lipid nanoparticles to epigenetically silence PCSK9 in the liver, reducing circulating PCSK9 and LDL-C. The treatment is given by intravenous infusion and aims for durable LDL-C reduction. Up to 64 participants will be enrolled at sites in Australia and New Zealand, with follow-up through roughly one year after treatment. The study focuses on adults with elevated LDL-C, with exclusions including recent ASCVD events and liver disease.
Why it matters
Potential benefit: If successful, patients could see a meaningful reduction in LDL-C and potentially lower ASCVD risk.
How similar studies have gone: This approach is exploratory; similar gene-silencing strategies have shown LDL-C reductions in early research but are not yet proven clinically.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Monash Health/ Victorian Heart Hospital (VHH)
Clayton, Victoria, Australia Recruiting -
Aotearoa Clinical Trials/Middlemore Hospital
Papatoetoe, Auckland, New Zealand Recruiting -
New Zealand Clinical Research (NZCR)
Christchurch, Christchurch, New Zealand Recruiting
Study contacts
- Study coordinator: Domenic Sacca
- Email: domenic.sacca@monash.edu
- Phone: +61 423245187
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.