Recruiting
Phase 1
Phase 2

ARO-DIMERPA

Sponsor:

Arrowhead Pharmaceuticals

Code:

NCT07223658

Conditions

Hyperlipidemia; Mixed

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ARO-DIMERPA

Placebo

Study Details

Brief 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.

Conditions

Hyperlipidemia; Mixed

Study ID

NCT07223658

Start date

Dec 22, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ARO-DIMERPA

ARO-DIMERPA in single or multiple ascending doses

placebo comparator: Placebo

Placebo (normal saline, 0.9%) in single or multiple matching doses

Interventions

ARO-DIMERPA

Subcutaneous (SC) injection

Placebo

Calculated volume to match active treatment by SC injection

Primary outcome measure

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 36 ]

Central Contacts and Locations

Central contacts

Medical Monitor

626-304-3400ARODIMERPA-1001@arrowheadpharma.com

Locations

Research Site 10

Recruiting

Calgary, Canada, T2N 4N1

Research Site 17

Recruiting

Chicoutimi, Canada, G7H 7K9

Research Site 16

Recruiting

Toronto, Canada, M1S 3V6

More Information

Sponsor

Arrowhead Pharmaceuticals

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arrowhead Pharmaceuticals on 2026-08-18.