NCT07223658

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P75+ for phase_1

Timeline
12mo left

Started Dec 2025

Geographic Reach
4 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Jul 2027

First Submitted

Initial submission to the registry

October 30, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 22, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

October 30, 2025

Last Update Submit

July 10, 2026

Conditions

Hyperlipidemia; Mixed

Outcome Measures

Primary Outcomes (1)

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

    Up to Week 36

Secondary Outcomes (15)

  • Percent Change from Baseline in Fasting LDL-C

    Baseline to Week 36

  • Percent Change from Baseline in Fasting TGs

    Baseline to Week 36

  • Percent Change from Baseline in Serum apoC-III

    Baseline to Week 36

  • Percent Change from Baseline in Serum PCSK9

    Baseline to Week 36

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

    Through 24 hours postdose

  • +10 more secondary outcomes

Study Arms (2)

ARO-DIMERPA

EXPERIMENTAL

ARO-DIMERPA in single or multiple ascending doses

Drug: ARO-DIMERPA

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ARO-DIMERPADRUG

Subcutaneous (SC) injection

ARO-DIMERPA
PlaceboDRUG

Calculated volume to match active treatment by SC injection

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

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 10

Calgary, T2N 4N1, 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 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

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Medical Monitor

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2025

First Posted

November 3, 2025

Study Start

December 22, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

NZ(5)CA(1)AU(6)GE(3)