This study is researching an experimental drug called ALN-APOC3 (called "study drug"). The study is focused on participants who have dyslipidemia (abnormal amounts of fats in the blood, including triglycerides and cholesterol), but who are otherwise healthy. The aim of the study is to see how safe and effective the study drug is. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * How the study drug changes lipid levels in the blood
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Administered as per the protocol
Administered as per the protocol
Arensia Exploratory Medicine at the Republican Clinical Hospital
Chisinau, Moldova
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Through Week 44
Severity of TEAEs
Time frame: Through Week 44
Percent changes in fasting concentrations of High-Density Lipoprotein Cholesterol (HDL-C)
Part B Only
Time frame: Baseline to week 24
Concentration of combined ALN-APOC3 and metabolites in plasma
Time frame: Through Week 44
Urinary excretion of combined ALN-APOC3 and metabolites
Part A Only
Time frame: Through 24 Hours, After Treatment
Percent change in fasting concentrations of APOC3
Time frame: Baseline to Week 12
Absolute change in fasting concentrations of APOC3
Time frame: Baseline to Week 12
Percent change in fasting concentrations of APOC3
Part B Only
Time frame: Baseline to Week 24
Absolute change in fasting concentrations of APOC3
Part B Only
Time frame: Baseline to Week 24
Percent change in fasting concentrations of HDL-C
Time frame: Baseline to Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Absolute change in fasting concentrations of HDL-C
Time frame: Baseline to Week 12
Absolute change in fasting concentrations of HDL-C
Part B Only
Time frame: Baseline to Week 24
Percent change in fasting concentrations of Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline to Week 12
Absolute change in fasting concentrations of LDL-C
Time frame: Baseline to Week 12
Percent change in fasting concentrations of LDL-C
Part B Only
Time frame: Baseline to Week 24
Absolute change in fasting concentrations of LDL-C
Part B Only
Time frame: Baseline to Week 24
Percent change in fasting concentrations of Triglycerides (TG)
Time frame: Baseline to Week 12
Absolute change in fasting concentrations of TG
Time frame: Baseline to Week 12
Percent change in fasting concentrations of TG
Part B Only
Time frame: Baseline to Week 24
Absolute change in fasting concentrations of TG
Part B Only
Time frame: Baseline to Week 24
Percent change in fasting concentrations of non-HDL-C
Time frame: Baseline to Week 12
Absolute change in fasting concentrations of non-HDL-C
Time frame: Baseline to Week 12
Percent change in fasting concentrations of non-HDL-C
Part B Only
Time frame: Baseline to Week 24
Absolute change in fasting concentrations of non-HDL-C
Part B Only
Time frame: Baseline to Week 24
Percent change in fasting concentrations of Apolipoprotein-B (APOB)
Time frame: Baseline to Week 12
Absolute change in fasting concentrations of APOB
Time frame: Baseline to Week 12
Percent change in fasting concentrations of APOB
Part B Only
Time frame: Baseline to Week 24
Absolute change in fasting concentrations of APOB
Part B Only
Time frame: Baseline to Week 24