NCT07428473RecruitingPhase 1
A Study of STX-1150 in Participants With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
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)
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 1 Feb 2026
- Start date
- 30 Jun 2026
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Monash University
- NCT number
- NCT07428473
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 64
- From 30 Jun 2026 to the primary completion date, 30 Dec 2028
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with PCSK9-inhibitor or other prior treatment within a specified timeframe
Other illness
- 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
Lab values
- Clinically significant abnormal laboratory values
Other
- Diagnosis of familial hypercholesterolemia
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health/ Victorian Heart Hospital (VHH) Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| New Zealand Clinical Research (NZCR) Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| Aotearoa Clinical Trials/Middlemore Hospital Coordinator of this site? Confirm its status | Papatoetoe | New Zealand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.