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Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia

RecruitingPhase 1, Phase 2

Sponsor: Arrowhead Pharmaceuticals

Conditions: Hyperlipidemia; Mixed

Interventions: ARO-DIMERPA, Placebo

Countries: Australia, Canada, Georgia, New Zealand

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Willing to follow diet counseling as per Investigator judgment based on local standard of care
* Specific fasting TG, LDL-C, and non-high density lipoprotein cholesterol levels at Screening
* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later

Exclusion Criteria:

* Current use or use within last 365 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any hepatocyte-targeted siRNA
* Current use or use within last 90 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any antisense oligonucleotide therapy
* Current use or use within last 60 days from Day 1 of any PCSK9 inhibitor monoclonal antibodies (eg, evolocumab or alirocumab)
* Uncontrolled hypertension
* History of bleeding diathesis or coagulopathy
* Current diagnosis of nephrotic syndrome

Note: Additional inclusion/exclusion criteria may apply per protocol.

Locations (17)

Charlestown, New South Wales, Australia
Morayfield, Queensland, Australia
East Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Perth, Western Australia, Australia
Clayton, Australia
Calgary, Canada
Chicoutimi, Canada
Toronto, Canada
Tbilisi, Georgia
Tbilisi, Georgia
Tbilisi, Georgia
Grafton, Auckland, New Zealand
Auckland, New Zealand
Auckland, New Zealand
Christchurch, New Zealand
Wellington, New Zealand