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

Primary Purpose

Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

SLN360

Placebo

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

No Longer Recruiting
No Longer Recruiting
No Longer Recruiting
No Longer Recruiting
No Longer Recruiting
No Longer Recruiting
No Longer Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

SLN360 Dose 1

SLN360 Dose 2

SLN360 Dose 3

Placebo Dose 1

Placebo Dose 2 and 3

Arm Description

SLN360 for subcutaneous injection

Sodium chloride for subcutaneous injection

Outcomes

Primary Outcome Measures

Time averaged change in Lp(a) from Baseline

Secondary Outcome Measures

Change (time-averaged and by visit) in Lp(a) from Baseline

Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline

Full Information

NCT ID

NCT05537571

First Posted

September 6, 2022

Last Updated

May 23, 2023

Sponsor

Silence Therapeutics plc

1. Study Identification

Unique Protocol Identification Number

NCT05537571

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 3, 2023 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Silence Therapeutics plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)

Keywords

Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SLN360 Dose 1

Arm Type

Experimental

Arm Description

SLN360 for subcutaneous injection

Arm Title

SLN360 Dose 2

Arm Type

Experimental

Arm Description

SLN360 for subcutaneous injection

Arm Title

SLN360 Dose 3

Arm Type

Experimental

Arm Description

SLN360 for subcutaneous injection

Arm Title

Placebo Dose 1

Arm Type

Placebo Comparator

Arm Description

Sodium chloride for subcutaneous injection

Arm Title

Placebo Dose 2 and 3

Arm Type

Placebo Comparator

Arm Description

Sodium chloride for subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

SLN360

Intervention Description

SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Sodium chloride, solution for injection

Primary Outcome Measure Information:

Title

Time averaged change in Lp(a) from Baseline

Time Frame

Week 36

Secondary Outcome Measure Information:

Title

Change (time-averaged and by visit) in Lp(a) from Baseline

Time Frame

Week 48

Title

Change (time-averaged and by visit) in Lp(a) from Baseline

Time Frame

Week 60

Title

Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline

Time Frame

Week 36

Title

Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline

Time Frame

Week 48

Title

Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline

Time Frame

Week 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

No Longer Recruiting

City

Perth

Country

Australia

Facility Name

No Longer Recruiting

City

Prague

Country

Czechia

Facility Name

No Longer Recruiting

City

Hellerup

Country

Denmark

Facility Name

No Longer Recruiting

City

Amsterdam

Country

Netherlands

Facility Name

No Longer Recruiting

City

Bardejov

Country

Slovakia

Facility Name

No Longer Recruiting

City

Cape Town

Country

South Africa

Facility Name

No Longer Recruiting

City

London

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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