ARO-DIMERPA for adults with mixed high cholesterol and triglycerides

Phase 1/2a, Double-blind, Placebo-controlled, Single and Multiple Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ARO-DIMERPA in Adult Subjects With Mixed Hyperlipidemia

This trial tests whether ARO-DIMERPA, given as a single dose or repeated doses, can lower LDL cholesterol and triglycerides in adults with mixed hyperlipidemia.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Arrowhead Pharmaceuticals (Industry-sponsored)
• Drugs / interventions: evolocumab, alirocumab
• Locations: 1 site (Christchurch)
• Trial ID: NCT07223658 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 interventional study enrolls adults with mixed hyperlipidemia to receive single or multiple doses of ARO-DIMERPA or placebo and follows them for safety, tolerability, pharmacokinetics, and pharmacodynamics. Lipid endpoints include changes in LDL-C and triglycerides, with regular laboratory monitoring. The design includes placebo controls and predefined cohorts for single‑dose and multiple‑dose administration. Participants must follow diet counseling per investigator judgment and comply with contraception rules if of childbearing potential.

Who should consider this trial

Good fit: Adults with mixed hyperlipidemia who meet specified fasting LDL-C, triglyceride, and non‑HDL thresholds, are willing to follow diet counseling, and agree to the study's contraception requirements are appropriate candidates.

Not a fit: People currently using hepatocyte‑targeted siRNA or antisense oligonucleotide therapies, or those who fail to meet the lipid or other eligibility criteria, are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, ARO-DIMERPA could provide a new treatment option that lowers both LDL cholesterol and triglycerides for people with mixed hyperlipidemia.

How similar studies have performed: Other hepatocyte‑targeted siRNA and antisense oligonucleotide agents have shown lipid‑lowering effects in clinical studies, but ARO-DIMERPA itself is a novel agent with limited prior human data.

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

Note: Additional inclusion/exclusion criteria may apply per protocol.

Where this trial is running

Christchurch

• Research Site 1 — Christchurch, New Zealand (Recruiting)

Study contacts

• Study coordinator: Medical Monitor

Conditions Hyperlipidemia; Mixed