Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) of single-dose ARO-DIMERPA and multiple doses of ARO-DIMERPA in adult participants with mixed hyperlipidemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
Subcutaneous (SC) injection
Calculated volume to match active treatment by SC injection
Research Site 1
Christchurch, New Zealand
RECRUITINGNumber of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 36
Percent Change from Baseline in Fasting LDL-C
Time frame: Baseline to Week 36
Percent Change from Baseline in Fasting TGs
Time frame: Baseline to Week 36
Percent Change from Baseline in Serum apoC-III
Time frame: Baseline to Week 36
Percent Change from Baseline in Serum PCSK9
Time frame: Baseline to Week 36
PK of ARO-DIMERPA: Maximum Observed Plasma Concentration (Cmax)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Time to Maximum Plasma Concentration (Tmax)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Area Under the Plasma Concentration (AUC) Versus Time Curve From Time Zero to 24 Hours (AUC0-24)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUC0-t)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Apparent Terminal Elimination Half-life (t1/2)
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Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Apparent Systemic Clearance (CL/F)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Apparent Terminal-phase Volume of Distribution (Vz/F)
Time frame: Through 24 hours postdose
PK of ARODIMERPA: Recovery of Unchanged Drug (Ae) in Urine From Time Zero to 24 Hours Postdose
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Percentage of Administered Drug Recovered (Fe) in Urine From Time Zero to 24 Hours Postdose
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Renal Clearance (CLR)
Time frame: Through 24 hours postdose