A Phase 1 interventional study of STX-1150 in Elevated LDL-C and High Cholesterol, sponsored by Monash University. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Monash University · Phase 1, Interventional, and Treatment
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.
STX-1150 is an investigational product designed to epigenetically silence the PCSK9 gene. It comprises an mRNA and a guide RNA (gRNA) delivered in a lipid nanoparticle (LNP) for intravenous (IV) infusion.
STX-1150 epigenetically silences the expression of the PCSK9 gene in the liver, thereby reducing circulating PCSK9 and LDL-C levels. The active components, an mRNA and a gRNA are encapsulated in lipid nanoparticles (LNPs) for targeted hepatic delivery. The gRNA precisely guides the complex to a specific locus within the PCSK9 gene promoter.
By reducing PCSK9 expression, STX-1150 prevents the degradation of LDL receptors (LDL-R), leading to increased LDL-R levels on hepatocytes and enhanced clearance of LDL-C from the bloodstream. This targeted and durable epigenetic silencing represents a promising therapeutic strategy for long-term LDL-C reduction, particularly benefiting patients with elevated LDL-C or a high risk for Atherosclerotic Cardiovascular Disease (ASCVD).
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 64 is below the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Monash University is the lead sponsor of 83 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part 1: An open-label, single ascending dose will serve to identify the Dose-Limiting Toxicities (DLTs) and Optimal Biological Dose (OBD) of STX-1150. Part 2: Following Part 1, an open-label, single or multi-dose expansion of the OBD cohort will be conducted to further characterize the effect of STX-1150 and obtain additional safety data at the OBD.
Drug: STX-1150
Drug: STX-1150 is an investigational product designed to epigenetically silence the PCSK9 gene. Epigenome modulation offers a way to silence genes without changing their underlying DNA sequence.
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 52 from administration of STX-1150
Incidence and Severity of Serious Adverse Events (SAEs)
Time frame: Up to Week 52 from administration of STX-1150
Incidence and Severity of Adverse Events of Special Interest (AESI)
Time frame: Up to Week 52 from administration of STX-1150
Incidence of dose-limiting toxicities (DLTs)
Time frame: Within 14 days from administration of STX-1150
Percent Change from Baseline in Plasma PCSK9 Concentration
Time frame: Up to Week 52
Percent Change from Baseline in LDL-C
Time frame: Up to 52 weeks
Plasma Concentrations of STX-1150 Lipid Components
Time frame: Up to 52 weeks
Number of Participants with Treatment-Induced Immunogenicity
Time frame: Up to 52 Weeks
Absolute Change from Baseline in LDL-C
Time frame: Up to 52 weeks
The Absolute Change from Baseline in Plasma PCSK9 Concentration
Time frame: Up to Week 52
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