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NCT Number: NCT07223658

Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia

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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Key information

Conditions

Hyperlipidemia; Mixed Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site 7, Charlestown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARO-DIMERPA

Drug

Subcutaneous (SC) injection

Placebo

Drug

Calculated volume to match active treatment by SC injection

Primary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to Week 36

Secondary outcomes

  1. Percent Change from Baseline in Fasting LDL-C

    Time frame: Baseline to Week 36

  2. Percent Change from Baseline in Fasting TGs

    Time frame: Baseline to Week 36

  3. Percent Change from Baseline in Serum apoC-III

    Time frame: Baseline to Week 36

  4. Percent Change from Baseline in Serum PCSK9

    Time frame: Baseline to Week 36

  5. PK of ARO-DIMERPA: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Through 24 hours postdose

  6. PK of ARO-DIMERPA: Time to Maximum Plasma Concentration (Tmax)

    Time frame: Through 24 hours postdose

  7. 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

  8. 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

  9. PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf)

    Time frame: Through 24 hours postdose

  10. PK of ARO-DIMERPA: Apparent Terminal Elimination Half-life (t1/2)

    Time frame: Through 24 hours postdose

  11. PK of ARO-DIMERPA: Apparent Systemic Clearance (CL/F)

    Time frame: Through 24 hours postdose

  12. PK of ARO-DIMERPA: Apparent Terminal-phase Volume of Distribution (Vz/F)

    Time frame: Through 24 hours postdose

  13. PK of ARODIMERPA: Recovery of Unchanged Drug (Ae) in Urine From Time Zero to 24 Hours Postdose

    Time frame: Through 24 hours postdose

  14. 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

  15. PK of ARO-DIMERPA: Renal Clearance (CLR)

    Time frame: Through 24 hours postdose

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Monitor

CONTACT

[email protected]

626-304-3400

Sponsors and collaborators

Lead sponsor

Arrowhead Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 3, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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