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Monoclonal Antibodies
Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)
Phase 1
Waitlist Available
Research Sponsored by Silence Therapeutics plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 150 and day 201
Summary
This trial will test a new treatment called SLN360 in patients with high levels of Lp(a). The treatment is given through an injection under the skin. Researchers will check if it is safe and how it affects the body. The treatment has shown promise in reducing Lp(a) levels significantly.
Eligible Conditions
- Dyslipidemia
- Hyperlipidemia
- Elevated Lipoprotein
- High Cholesterol
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 150 and day 201
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 150 and day 201
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of treatment-emergent adverse events
Secondary study objectives
Pharmacodynamic: Change in Lp(a)
Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)
Pharmacokinetic: area under the plasma concentration (AUC)
+1 moreTrial Design
11Treatment groups
Experimental Treatment
Placebo Group
Group I: 900 mgExperimental Treatment1 Intervention
Group II: 600 mg multi doseExperimental Treatment1 Intervention
Group III: 600 mgExperimental Treatment1 Intervention
Group IV: 300 mg multi doseExperimental Treatment1 Intervention
Group V: 300 mgExperimental Treatment1 Intervention
Group VI: 30 mgExperimental Treatment1 Intervention
Group VII: 200 mg multi doseExperimental Treatment1 Intervention
Group VIII: 100 mg multi doseExperimental Treatment1 Intervention
Group IX: 100 mgExperimental Treatment1 Intervention
Group X: Placebo multi dosePlacebo Group1 Intervention
Group XI: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SLN360
2023
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
Silence Therapeutics plcLead Sponsor
5 Previous Clinical Trials
313 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
96 Previous Clinical Trials
29,807 Total Patients Enrolled
1 Trials studying Dyslipidemia
44 Patients Enrolled for Dyslipidemia