Phase 2 study of SLN360 in participants with elevated lipoprotein(a)
Research type
Research Study
Full title
A multi-centre, randomised, double-blind placebo-controlled, Phase 2 study to investigate efficacy, safety and tolerability of SLN360 in participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events
IRAS ID
1006507
Contact name
Cristina D'Angeli
Contact email
Sponsor organisation
Silence Therapeutics plc
Eudract number
2022-001876-32
Clinicaltrials.gov Identifier
Research summary
SLN360 -002 is a multi-centre, randomised, double-blind, placebo-controlled phase 2 study to investigate efficacy, safety and tolerability of SLN360 in participants with elevated lipoprotein (a) and at high risk of ASCVD events.
Eligible participants will be randomised into one of the 5 treatment groups and will receive either placebo (25% chance) or SLN360 (300 mg or 450 mg doses) (75% chance) every 16 weeks or 24 weeks. SLN360 or placebo will be administered subcutaneously (injection under the skin). Participants will receive 1 or 2 injections on the dosing visits, the number of injections is based on which group participants are in.
Participation will include an optional pre-screening period, a screening period a treatment period and a follow-up period
About 15 study visits will be scheduled during participation.Investigational product SLN360:
SLN360 is a gene ‘silencing’ therapy (called short interfering RNA or siRNA for short) – one that is designed to temporarily stop a specific gene from working. In this case, it aims to ‘silence’ and stop the function of LPA, a gene that tells the body to make a specific protein that is only found in Lp(a). This is not to be confused with ‘gene therapy’ which is a type of therapy in which new DNA is introduced into the body to correct a missing or faulty gene. SLN360 is not gene therapy.
The primary objective is to evaluate the effect of SLN360 on circulating levels of Lp(a) in participants with elevated Lp(a) at high risk of ASCVD events.
The secondary objectives are to:
• Evaluate safety and tolerability of SLN360
• Evaluate the effects of SLN360 on LDL-C and apolipoprotein B (apoB) in these populations
Approximately 160 participants will take part in this study worldwide.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0232
Date of REC Opinion
15 Nov 2022
REC opinion
Further Information Favourable Opinion