Status:
RECRUITING
Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Hyperlipidemia; Mixed
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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-DIME...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT07223658
Start Date
December 22 2025
End Date
July 1 2027
Last Update
January 9 2026
Active Locations (1)
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1
Research Site 1
Christchurch, New Zealand, 8011