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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARO-DIMERPA | Experimental | ARO-DIMERPA in single or multiple ascending doses |
|
| Placebo | Placebo Comparator | Placebo (normal saline, 0.9%) in single or multiple matching doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARO-DIMERPA | Drug | Subcutaneous (SC) injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Fasting LDL-C | Baseline to Week 36 | |
| Percent Change from Baseline in Fasting TGs | Baseline to Week 36 | |
| Percent Change from Baseline in Serum apoC-III |
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Inclusion Criteria:
Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply per protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Contact | 626-304-3400 | ARODIMERPA-1001@arrowheadpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 7 | Recruiting | Charlestown | New South Wales | 2290 | Australia | |
| Research Site 5 |
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| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Drug |
Calculated volume to match active treatment by SC injection |
|
| Baseline to Week 36 |
| Percent Change from Baseline in Serum PCSK9 | Baseline to Week 36 |
| PK of ARO-DIMERPA: Maximum Observed Plasma Concentration (Cmax) | Through 24 hours postdose |
| PK of ARO-DIMERPA: Time to Maximum Plasma Concentration (Tmax) | 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) | Through 24 hours postdose |
| PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUC0-t) | Through 24 hours postdose |
| PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) | Through 24 hours postdose |
| PK of ARO-DIMERPA: Apparent Terminal Elimination Half-life (t1/2) | Through 24 hours postdose |
| PK of ARO-DIMERPA: Apparent Systemic Clearance (CL/F) | Through 24 hours postdose |
| PK of ARO-DIMERPA: Apparent Terminal-phase Volume of Distribution (Vz/F) | Through 24 hours postdose |
| PK of ARODIMERPA: Recovery of Unchanged Drug (Ae) in Urine From Time Zero to 24 Hours Postdose | Through 24 hours postdose |
| PK of ARO-DIMERPA: Percentage of Administered Drug Recovered (Fe) in Urine From Time Zero to 24 Hours Postdose | Through 24 hours postdose |
| PK of ARO-DIMERPA: Renal Clearance (CLR) | Through 24 hours postdose |
| Recruiting |
| Morayfield |
| Queensland |
| 4506 |
| Australia |
| Research Site 8 | Recruiting | East Melbourne | Victoria | 3002 | Australia |
| Research Site 4 | Recruiting | Melbourne | Victoria | 3153 | Australia |
| Research Site 9 | Recruiting | Perth | Western Australia | 6009 | Australia |
| Research Site 11 | Recruiting | Clayton | 3168 | Australia |
| Research Site 10 | Recruiting | Calgary | T2N 4N1 | Canada |
| Research Site 6 | Recruiting | Grafton | Auckland | 1023 | New Zealand |
| Research Site 3 | Recruiting | Auckland | 2025 | New Zealand |
| Research Site 2 | Recruiting | Auckland | 622 | New Zealand |
| Research Site 1 | Recruiting | Christchurch | 8011 | New Zealand |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |