ARO-DIMERPA for adults with mixed high cholesterol and triglycerides
Official title: 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
Run by Arrowhead Pharmaceuticals · NCT07223658 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | Arrowhead Pharmaceuticals Industry-sponsored |
| Drugs / interventions | evolocumab, alirocumab |
| Locations | 19 sites (Charlestown, New South Wales and 18 other locations) |
| Status | Recruiting |
| Started | December 22, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07223658 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Research Site 7
Charlestown, New South Wales, Australia Recruiting -
Research Site 5
Morayfield, Queensland, Australia Recruiting -
Research Site 8
East Melbourne, Victoria, Australia Recruiting -
Research Site 4
Melbourne, Victoria, Australia Recruiting -
Research Site 9
Perth, Western Australia, Australia Recruiting -
Research Site 11
Clayton, Australia Recruiting
Show 13 more locations
-
Research Site
Penticton, British Columbia, Canada Recruiting -
Research Site 17
Chicoutimi, Canada Recruiting -
Research Site 16
Toronto, Canada Recruiting -
Research Site
Toronto, Canada Recruiting -
Research Site 13
Tbilisi, Georgia Recruiting -
Research Site 14
Tbilisi, Georgia Recruiting -
Research Site 15
Tbilisi, Georgia Recruiting -
Research Site
Chisinau, Moldova Recruiting -
Research Site 6
Grafton, Auckland, New Zealand Recruiting -
Research Site 3
Auckland, New Zealand Recruiting -
Research Site 2
Auckland, New Zealand Recruiting -
Research Site 1
Christchurch, New Zealand Recruiting -
Research Site 12
Wellington, New Zealand Recruiting
Study contacts
- Study coordinator: Medical Monitor
- Email: ARODIMERPA-1001@arrowheadpharma.com
- Phone: 626-304-3400
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating HST101 for lowering cholesterol in Chinese patients
This study is testing if a new drug called HST101 can lower cholesterol levels in Chinese patients who have high cholesterol and are at risk for heart disease.
-
Enlicitide (MK-0616) for adults with high cholesterol in India
This study tests whether enlicitide helps lower bad cholesterol (LDL-C) compared with placebo in adults with hyperlipidemia/hypercholesterolemia.
-
HRS-7249 extension study for people with high triglycerides
This extension study tests whether repeat injections of HRS-7249 are safe and keep triglyceride levels low in adults who previously completed the parent study or have high fasting triglycerides.
-
Bacillus subtilis and Enterococcus faecium Probiotic Plus Lipid-Lowering Therapy for HTG-AP
This trial tests whether adding a probiotic capsule to standard lipid-lowering therapy helps people with mild HTG-AP see lower triglycerides and better recovery.
-
EHR-guided LDL cholesterol optimization after a heart event
A pharmacist-guided program using electronic health records to help adults in Alberta reach LDL goals after a heart event by adjusting medications and ordering tests.
-
Spermidine supplement for lipid and weight changes in adults with obesity and high cholesterol
This study tests whether taking spermidine daily for 1 month can improve blood lipids and body weight in adults who are overweight or obese with high cholesterol, while monitoring safety.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.