ClinicalTrials.gg
RecruitingNCT07223658Updated Oct 13, 2026

Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia

A Phase 1/2 interventional study of ARO-DIMERPA and Placebo in Hyperlipidemia; Mixed, sponsored by Arrowhead Pharmaceuticals. Recruiting at 19 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Arrowhead Pharmaceuticals · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Updated Oct 13, 2026First site in MoldovaPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperlipidemia; Mixed
03

In context

Hyperlipoproteinemia Type II

249 studies on the registry are indexed under Hyperlipoproteinemia Type II; 56 are open to participants now.

This study's planned enrollment of 78 is below the median of 134 across 178 interventional studies indexed under Hyperlipoproteinemia Type II.

Browse Hyperlipoproteinemia Type II studies →

Lead sponsor

Arrowhead Pharmaceuticals is the lead sponsor of 50 studies on the registry; 9 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 12 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 must agree to use highly effective 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

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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    ARO-DIMERPA

    ARO-DIMERPA in single or multiple ascending doses

    Drug: ARO-DIMERPA

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugARO-DIMERPA

    Subcutaneous (SC) injection

  • DrugPlacebo

    Calculated volume to match active treatment by SC injection

06

What researchers measure

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

07

Study locations

19 of 19 sites recruiting
  • Research Site 7
    Charlestown, New South Wales 2290, Australia
    Recruiting
  • Research Site 5
    Morayfield, Queensland 4506, Australia
    Recruiting
  • Research Site 8
    East Melbourne, Victoria 3002, Australia
    Recruiting
  • Research Site 4
    Melbourne, Victoria 3153, Australia
    Recruiting
  • Research Site 9
    Perth, Western Australia 6009, Australia
    Recruiting
  • Research Site 11
    Clayton, 3168, Australia
    Recruiting
  • Research Site
    Penticton, British Columbia V2A 5L5, Canada
    Recruiting
  • Research Site 17
    Chicoutimi, G7H 7K9, Canada
    Recruiting
  • Research Site 16
    Toronto, M1S 3V6, Canada
    Recruiting
  • Research Site
    Toronto, M4G 3E8, Canada
    Recruiting
  • Research Site 13
    Tbilisi, 102, Georgia
    Recruiting
  • Research Site 14
    Tbilisi, 144, Georgia
    Recruiting
  • Research Site 15
    Tbilisi, 191, Georgia
    Recruiting
  • Research Site
    Chisinau, MD-2025, Moldova
    Recruiting
  • Research Site 6
    Grafton, Auckland 1023, New Zealand
    Recruiting
  • Research Site 3
    Auckland, 2025, New Zealand
    Recruiting
  • Research Site 2
    Auckland, 622, New Zealand
    Recruiting
  • Research Site 1
    Christchurch, 8011, New Zealand
    Recruiting
  • Research Site 12
    Wellington, 6021, New Zealand
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
3 sites added, 1 site removed — first site in Moldova
Show 3 added (2 Canada, 1 Moldova)
  • Research Site · Penticton, Canada
  • Research Site · Toronto, Canada
  • Research Site · Chisinau, Moldova
Show 1 removed
  • Research Site 10 · Calgary, Canada
Oct 13, 2026
Primary completion
Sep 30, 2026→Jul 2027
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    3 sites added, 1 site removed — first site in Moldova
    Show 3 added (2 Canada, 1 Moldova)
    • Research Site · Penticton, Canada
    • Research Site · Toronto, Canada
    • Research Site · Chisinau, Moldova
    Show 1 removed
    • Research Site 10 · Calgary, Canada
    Primary completion Sep 30, 2026→Jul 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07223658
Responsible party
Sponsor
First posted
Nov 3, 2025
Start date
Dec 22, 2025
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Medical Monitor
Contact
ARODIMERPA-1001@arrowheadpharma.com
626-304-3400

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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