Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2 study to evaluate the efficacy, safety and tolerability of SLN360 administered subcutaneously (SC) compared with placebo in adult participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Silence Therapeutics plc

Criteria

Inclusion Criteria:

• Lipoprotein(a) at screening equal to or greater than 125 nmol/L

• At high risk of ASCVD events

• A body mass index at screening in the range of 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria:

• Renal dysfunction with estimated glomerular filtration rate less than 30 mL/min/1.73 m2 at screening

• History or clinical evidence of hepatic dysfunction

• Malignancy within the 5 years before screening

• Fasting triglycerides >400 mg/dL (4.5 mmol/L) at screening

• Currently receiving or <12 weeks at Day 1 since receiving >200 mg/day niacin or niacin derivative drugs

• Treatment with lipid/lipoprotein apheresis within the 12 weeks before screening

• Any previous use of approved or experimental small interfering RNA (siRNA) therapy (e.g. inclisiran). NB: use of messenger RNA (mRNA) based vaccines for infectious diseases is permitted