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NCT03783377
Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)
Phase 1 trial testing ARO-APOC3 in Hypertriglyceridemia in 112 participants. Completed in 11 February 2021.
11 February 2021
Quick facts
| Lead sponsor | Arrowhead Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 8 March 2019 |
| Primary completion | 11 February 2021 |
| Estimated completion | 11 February 2021 |
| Sites | 10 locations across New Zealand, Canada, Australia |
Drugs / interventions tested
- ARO-APOC3 — full drug profile →
- sterile normal saline (0.9% NaCl) — full drug profile →
Conditions studied
- Hypertriglyceridemia — all drugs for Hypertriglyceridemia →
- Familial Chylomicronemia — all drugs for Familial Chylomicronemia →
Sponsor
Arrowhead Pharmaceuticals — full company profile →
Who can join
Adults 18 to 70, any sex, with Hypertriglyceridemia or Familial Chylomicronemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and in patients with severe hypertriglyceridemia and familial chylomicronemia syndrome (FCS).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic siRNA: state of the art.
Hu B, Zhong L, Weng Y, Peng L, et al · · 2020 · cited 991× · PMID 32561705 · DOI 10.1038/s41392-020-0207-x -
Paving the Road for RNA Therapeutics.
Dammes N, Peer D. · · 2020 · cited 159× · PMID 32893005 · DOI 10.1016/j.tips.2020.08.004 -
The landscape of nanoparticle-based siRNA delivery and therapeutic development.
Moazzam M, Zhang M, Hussain A, Yu X, et al · · 2024 · cited 116× · PMID 38204162 · DOI 10.1016/j.ymthe.2024.01.005 -
Lipid Lowering Drugs: Present Status and Future Developments.
Ruscica M, Ferri N, Santos RD, Sirtori CR, et al · · 2021 · cited 54× · PMID 33694108 · DOI 10.1007/s11883-021-00918-3 -
New Therapies for Lowering Triglyceride-Rich Lipoproteins: JACC Focus Seminar 3/4.
Rosenson RS, Shaik A, Song W. · · 2021 · cited 48× · PMID 34711341 · DOI 10.1016/j.jacc.2021.08.051 -
Therapeutic RNA Delivery for COVID and Other Diseases.
Dobrowolski C, Paunovska K, Hatit MZC, Lokugamage MP, et al · · 2021 · cited 46× · PMID 33661555 · DOI 10.1002/adhm.202002022 -
RNA Interference Therapy Targeting Apolipoprotein C-III in Hypertriglyceridemia.
Gaudet D, Clifton P, Sullivan D, Baker J, et al · · 2023 · cited 43× · PMID 38320498 · DOI 10.1056/evidoa2200325 -
Antisense Oligonucleotides and Small Interfering RNA for the Treatment of Dyslipidemias.
Gareri C, Polimeni A, Giordano S, Tammè L, et al · · 2022 · cited 36× · PMID 35807171 · DOI 10.3390/jcm11133884
Verify or expand the search:
- PubMed search for NCT03783377
- 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.
- NCT05413135 — Study of ARO-APOC3 in Adults With Dyslipidemia · Phase 2 · completed
- 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
Other recruiting trials for Hypertriglyceridemia
Currently open trials in the same condition.
- NCT07406191 — WB-EMS Effects on Cardiometabolic Risk Factors · NA · recruiting
- NCT07004777 — Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition · NA · recruiting
- NCT07140809 — a Phase 1b/2a Study of JMT202 Injection in Participants With Hypertriglyceridemia · Phase 1, PHASE2 · recruiting
- NCT06494488 — Differential Thrombogenesis by EPA and DHA Mediated by HDL · EARLY_PHASE1 · recruiting
- NCT06783881 — Single-ascending Dose Study of Kylo-12 in Healthy Subjects · Phase 1 · active not 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
- NCT05413135 — Study of ARO-APOC3 in Adults With Dyslipidemia · Phase 2 · completed
- NCT05276570 — Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease · Phase 1, PHASE2 · completed
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 NCT03783377 (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: 24 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/NCT03783377.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing