Recruiting

A Study 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…

ClinicalTrials.gov IDNCT07428473

PhasePHASE1

Enrollment64

SponsorMonash University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Elevated LDL-C and High Cholesterol

About this study

Interventions

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.

Primary outcomes

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) (Up to Week 52 from administration of STX-1150)
Incidence and Severity of Serious Adverse Events (SAEs) (Up to Week 52 from administration of STX-1150)
Incidence and Severity of Adverse Events of Special Interest (AESI) (Up to Week 52 from administration of STX-1150)

Eligibility information

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

Study locations

Monash Health/ Victorian Heart Hospital (VHH), Clayton, Victoria 3168 Australia
Aotearoa Clinical Trials/Middlemore Hospital, Papatoetoe, Auckland 2025 New Zealand
New Zealand Clinical Research (NZCR), Christchurch, Christchurch 8011 New Zealand

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.