Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia

NCT07223658 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ARODIMERPA-1001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

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

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-DIMERPA DRUG

Subcutaneous (SC) injection

ARO-DIMERPA

Placebo DRUG

Calculated volume to match active treatment by SC injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (1)

Research Site 1

Christchurch, 8011, New Zealand

RECRUITING

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Medical Monitor

CONTACT

626-304-3400; ARODIMERPA-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): June 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)