Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Hyperlipidemia; Mixed
In brief
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.
Key facts
- Study ID
- NCT07223658
- Run by
- Arrowhead Pharmaceuticals
- People needed
- 78
- Starts
- 2025-12-22
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- Note: Additional inclusion/exclusion criteria may apply per protocol.
Where it is running
- Research Site 7 — Charlestown, New South Wales, Australia (enrolling)
- Research Site 5 — Morayfield, Queensland, Australia (enrolling)
- Research Site 8 — East Melbourne, Victoria, Australia (enrolling)
- Research Site 4 — Melbourne, Victoria, Australia (enrolling)
- Research Site 9 — Perth, Western Australia, Australia (enrolling)
- Research Site 11 — Clayton, Australia (enrolling)
- Research Site 10 — Calgary, Canada (enrolling)
- Research Site 13 — Tbilisi, Georgia (enrolling)
- Research Site 14 — Tbilisi, Georgia (enrolling)
- Research Site 15 — Tbilisi, Georgia (enrolling)
- Research Site 6 — Grafton, Auckland, New Zealand (enrolling)
- Research Site 3 — Auckland, New Zealand (enrolling)
- Research Site 2 — Auckland, New Zealand (enrolling)
- Research Site 1 — Christchurch, New Zealand (enrolling)
- Research Site 12 — Wellington, New Zealand (enrolling)
Full record on ClinicalTrials.gov
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