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NCT05413135
Study of ARO-APOC3 in Adults With Dyslipidemia
Phase 2 trial testing ARO-APOC3 in Dyslipidemias in 418 participants. Completed in 18 September 2025.
18 September 2025
Quick facts
| Lead sponsor | Arrowhead Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 418 |
| Start date | 7 July 2022 |
| Primary completion | 18 September 2025 |
| Estimated completion | 18 September 2025 |
| Sites | 60 locations across New Zealand, Netherlands, Hungary, Poland, Canada, Australia, United States |
Drugs / interventions tested
- ARO-APOC3 — full drug profile →
Conditions studied
- Dyslipidemias — all drugs for Dyslipidemias →
Sponsor
Arrowhead Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Dyslipidemias. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continued to meet eligibility criteria had the option to be enrolled into this study. Eligible enrolled participants initially received open-label ARO-APOC3 every three or six months at the assigned dose level of the parent study until a final dose of 25 mg was selected, at which point all participants transitioned to the selected dosing regimen of 25 mg every 3 months.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Exploring apolipoprotein C-III: pathophysiological and pharmacological relevance.
Packard CJ, Pirillo A, Tsimikas S, Ference BA, et al · · 2024 · cited 33× · PMID 38039351 · DOI 10.1093/cvr/cvad177 -
Hepatocyte targeting <i>via</i> the asialoglycoprotein receptor.
Ramírez-Cortés F, Ménová P. · · 2025 · cited 22× · PMID 39628900 · DOI 10.1039/d4md00652f -
New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2023.
Tamargo J, Agewall S, Borghi C, Ceconi C, et al · · 2024 · cited 13× · PMID 38379024 · DOI 10.1093/ehjcvp/pvae013 -
Current RNA strategies in treating cardiovascular diseases.
Chia SPS, Pang JKS, Soh BS. · · 2024 · cited 13× · PMID 38291757 · DOI 10.1016/j.ymthe.2024.01.028 -
New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2024.
Tamargo J, Agewall S, Ambrosio G, Borghi C, et al · · 2025 · cited 6× · PMID 40058879 · DOI 10.1093/ehjcvp/pvaf012 -
RNA interference therapy in cardiology: will new targets improve therapeutic goals?
Fazoli RT, Drager LF, Kalil-Filho R, Generoso G. · · 2024 · cited 4× · PMID 39188988 · DOI 10.7573/dic.2024-3-1 -
Realizing the therapeutic potential of rapid knockdown of transthyretin via RNA interference in transthyretin amyloidosis.
Grogan M, Sheikh FH, Sperry BW, Sweetser MT, et al · · 2025 · PMID 40686854 · DOI 10.1016/j.omtn.2025.102590
Verify or expand the search:
- PubMed search for NCT05413135
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ARO-APOC3
Trials testing the same drug.
- NCT04998201 — Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dyslipidemia · Phase 2 · completed
- NCT04720534 — Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia · Phase 2 · completed
- NCT03783377 — Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndr · Phase 1 · completed
Other recruiting trials for Dyslipidemias
Currently open trials in the same condition.
- NCT07308314 — Taining Golden Lake Comprehensive Chronic Disease Management Initiative · recruiting
- NCT06526273 — PILI 'Āina Household · NA · recruiting
- NCT06797401 — Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia · Phase 2 · recruiting
- NCT06380322 — Military Health and Nutrition Examination Study · recruiting
- NCT06183307 — Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia · NA · recruiting
Other Arrowhead Pharmaceuticals trials
Trials by the same sponsor.
- NCT07037771 — A Phase 3 Study of Zodasiran in Adolescent and Adult Subjects With Homozygous Familial Hypercholesterolemia (YOSEMITE) · Phase 3 · recruiting
- NCT05537025 — Study of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis · Phase 1, PHASE2 · completed
- NCT05533294 — Study of ARO-RAGE in Healthy Subjects · Phase 1 · completed
- NCT05276570 — Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease · Phase 1, PHASE2 · completed
- NCT05292950 — Study of ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung Disease · Phase 1, PHASE2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05413135 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Arrowhead Pharmaceuticals
- Last refreshed: 17 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05413135.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing