Clinical trial Recruiting at 19 sites Phase1; Phase2 Interventional Ages 18 and up

ARO-DIMERPA for adults with mixed high cholesterol and triglycerides

Official 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

Run by Arrowhead Pharmaceuticals · NCT07223658 · Data updated 2026-11-12

This trial tests whether ARO-DIMERPA, given as a single dose or repeated doses, can lower LDL cholesterol and triglycerides in adults with mixed hyperlipidemia.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment78 (estimated)
SponsorArrowhead Pharmaceuticals
Industry-sponsored
Drugs / interventionsevolocumab, alirocumab
Locations19 sites (Charlestown, New South Wales and 18 other locations)
StatusRecruiting
StartedDecember 22, 2025
Main results expectedJuly 2027
Study endsJuly 2027
Registry record updatedOctober 13, 2026
Trial IDNCT07223658 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with mixed hyperlipidemia who meet specified fasting LDL-C, triglyceride, and non‑HDL thresholds, are willing to follow diet counseling, and agree to the study's contraception requirements are appropriate candidates.

Probably not a fit

People currently using hepatocyte‑targeted siRNA or antisense oligonucleotide therapies, or those who fail to meet the lipid or other eligibility criteria, are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional study enrolls adults with mixed hyperlipidemia to receive single or multiple doses of ARO-DIMERPA or placebo and follows them for safety, tolerability, pharmacokinetics, and pharmacodynamics. Lipid endpoints include changes in LDL-C and triglycerides, with regular laboratory monitoring. The design includes placebo controls and predefined cohorts for single‑dose and multiple‑dose administration. Participants must follow diet counseling per investigator judgment and comply with contraception rules if of childbearing potential.

Why it matters

Potential benefit: If successful, ARO-DIMERPA could provide a new treatment option that lowers both LDL cholesterol and triglycerides for people with mixed hyperlipidemia.

How similar studies have gone: Other hepatocyte‑targeted siRNA and antisense oligonucleotide agents have shown lipid‑lowering effects in clinical studies, but ARO-DIMERPA itself is a novel agent with limited prior human data.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Research Site 7
    Charlestown, New South Wales, Australia
    Recruiting
  • Research Site 5
    Morayfield, Queensland, Australia
    Recruiting
  • Research Site 8
    East Melbourne, Victoria, Australia
    Recruiting
  • Research Site 4
    Melbourne, Victoria, Australia
    Recruiting
  • Research Site 9
    Perth, Western Australia, Australia
    Recruiting
  • Research Site 11
    Clayton, Australia
    Recruiting
Show 13 more locations
  • Research Site
    Penticton, British Columbia, Canada
    Recruiting
  • Research Site 17
    Chicoutimi, Canada
    Recruiting
  • Research Site 16
    Toronto, Canada
    Recruiting
  • Research Site
    Toronto, Canada
    Recruiting
  • Research Site 13
    Tbilisi, Georgia
    Recruiting
  • Research Site 14
    Tbilisi, Georgia
    Recruiting
  • Research Site 15
    Tbilisi, Georgia
    Recruiting
  • Research Site
    Chisinau, Moldova
    Recruiting
  • Research Site 6
    Grafton, Auckland, New Zealand
    Recruiting
  • Research Site 3
    Auckland, New Zealand
    Recruiting
  • Research Site 2
    Auckland, New Zealand
    Recruiting
  • Research Site 1
    Christchurch, New Zealand
    Recruiting
  • Research Site 12
    Wellington, New Zealand
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.