Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia

NCT ID: NCT07223658

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-22
• Study Completion Date: 2027-07-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ARO-DIMERPA

ARO-DIMERPA in single or multiple ascending doses

Group Type: EXPERIMENTAL

ARO-DIMERPA

Intervention Type: DRUG

Subcutaneous (SC) injection

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Calculated volume to match active treatment by SC injection

Interventions

ARO-DIMERPA

Subcutaneous (SC) injection

Intervention Type: DRUG

Placebo

Calculated volume to match active treatment by SC injection

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arrowhead Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site 1

Christchurch, , New Zealand

Site Status: RECRUITING

Countries

New Zealand

Central Contacts

Medical Monitor

Role: CONTACT

ARODIMERPA-1001@arrowheadpharma.com

626-304-3400

Other Identifiers

ARODIMERPA-1001

Identifier Type: -

Identifier Source: org_study_id