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RecruitingPhase 1Phase 2NCT07223658

Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia

Phase 1/2a, Double-blind, Placebo-controlled, Single and Multiple Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ARO-DIMERPA in Adult Subjects With Mixed Hyperlipidemia

Sponsor

Arrowhead Pharmaceuticals

Enrollment

78 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Hyperlipidemia; Mixed

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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

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Interventions

DRUGARO-DIMERPA

Subcutaneous (SC) injection

DRUGPlacebo

Calculated volume to match active treatment by SC injection

Locations(1)

Research Site 1

Christchurch, New Zealand

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NCT07223658