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PALISADE
A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Familial Chylomicronemia Syndrome
Sponsor study identifier
interventional
75
21 countries
58
Study Start
December 14, 2021
Actual (reported)Primary Completion
April 29, 2024
Actual (reported)Study Completion
April 21, 2026
Actual (reported)The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 (plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive plozasiran.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 21, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2021
Actual (reported)October 22, 2021
Actual (reported)December 14, 2021
Actual (reported)April 29, 2024
Actual (reported)February 4, 2026
Actual (reported)April 21, 2026
Actual (reported)Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG)
Baseline, Month 10
Percent Change From Baseline in Fasting TG at Month 10 and Month 12 (Averaged)
Baseline, Month 10, Month 12
Percent Change From Baseline in Apolipoprotein C-III (APOC3) at Month 10
Baseline, Month 10
Percent Change From Baseline in Fasting APOC3 at Month 12
Baseline, Month 12
Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Randomized Period)
From first dose of study drug through Month 12 (Randomized Period)
Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Open-Label Period)
From first dose of study drug through Month 36 (Open-Label Period)
Randomized Period: plozasiran 25 mg Q3M for a total of 4 doses. Open-label Period (Parts A and B): plozasiran 25 mg Q3M for a total of 8 doses.
Randomized Period: volume-matched placebo every 3 months (Q3M) for a total of 4 doses. Open-label Period (Parts A and B): plozasiran 25 mg Q3M for a total of 8 doses.
ARO-APOC3 subcutaneous (SC) injection
Clinical Site 1
Boca Raton, Florida, 33434, United States
Clinical Site 2
Suwanee, Georgia, 30024, United States
Clinical Site 3
Indianapolis, Indiana, 46290, United States
Clinical Site 4
Elkridge, Maryland, 21075, United States
Clinical Site 5
St Louis, Missouri, 63110, United States
Clinical Site 7
New York, New York, 10016, United States
Clinical Site 6
New York, New York, 10029, United States
Loomba R, de-Madaria E, Afghani E, Singh VK, Leeper NJ. Clinical Trial: Plozasiran Prevents Recurrent Pancreatitis in Adults With Very Severe Hypertriglyceridemia-Results of a Post Hoc Analysis of the Phase 3 PALISADE Study. Aliment Pharmacol Ther. 2026 May;63(9):1236-1245. doi: 10.1111/apt.70623. Epub 2026 Apr 1.
Watts GF, Rosenson RS, Hegele RA, Goldberg IJ, Gallo A, Mertens A, Baass A, Zhou R, Muhsin M, Hellawell J, Leeper NJ, Gaudet D; PALISADE Study Group. Plozasiran for Managing Persistent Chylomicronemia and Pancreatitis Risk. N Engl J Med. 2025 Jan 9;392(2):127-137. doi: 10.1056/NEJMoa2409368. Epub 2024 Sep 2.
75 participants (actual enrollment reported by the registry).
First Submitted
October 11, 2021
First Posted
October 22, 2021
Study Start
December 14, 2021
Actual (reported)Randomized Period: plozasiran 25 mg Q3M for a total of 4 doses. Open-label Period: plozasiran 50 mg (Part A), then 25 mg (Part B) Q3M for a total of 8 doses.
Randomized Period: volume-matched placebo every 3 months (Q3M) for a total of 4 doses. Open-label Period: plozasiran 50 mg (Part A), then 25 mg (Part B) Q3M for a total of 8 doses.
sterile normal saline (0.9% NaCl) SC injection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Clinical Site 8
Austin, Texas, 78731, United States
Clinical Site 9
Norfolk, Virginia, 23510, United States
Clinical Site 10
Córdoba, X5003DCE, Argentina
Clinical Site 11
Formosa, 3600, Argentina
Clinical Site 14
Camperdown, New South Wales, 2050, Australia
Clinical Site 15
St Leonards, New South Wales, 2065, Australia
Clinical Site 16
Melbourne, Victoria, 3004, Australia
Clinical Site 12
Melbourne, 3081, Australia
Clinical Site 13
Nedlands, 6009, Australia
Clinical Site 17
Graz, 8036, Austria
Clinical Site 18
Edegem, 2650, Belgium
Clinical Site 19
Ghent, 9000, Belgium
Clinical Site 20
Leuven, 3000, Belgium
Clinical Site 21
Liège, 4000, Belgium
Clinical Site 22
London, Ontario, N6A 5B7, Canada
Clinical Site 23
Toronto, Ontario, M5G 2C4, Canada
Clinical Site 24
Chicoutimi, Quebec, G7H 7K9, Canada
Clinical Site 25
Montreal, Quebec, H2W 1R7, Canada
Clinical Site 26
Québec, Quebec, G1V 4W2, Canada
Clinical Site 27
Zagreb, 10000, Croatia
Clinical Site 29
Marseille, Cedez 05, 13385, France
Clinical Site 28
Paris, 75013, France
Clinical Site 30
Jena, 7740, Germany
Clinical Site 31
Leipzig, 4103, Germany
Clinical Site 32
Galway, H91 YR71, Ireland
Clinical Site 33
Jerusalem, 9112001, Israel
Clinical Site 34
Chiba, 260-8677, Japan
Clinical Site 35
Ishikawa, 920-8641, Japan
Clinical Site 36
Osaka, 598-0048, Japan
Clinical Site 37
Tochigi, 329-0498, Japan
Clinical Site 38
Tokyo, 113-8655, Japan
Clinical Site 39
Tokyo, Japan
Clinical Site 41
Tlalpan, Mexico DF, 14000, Mexico
Clinical Site 42
Cuernavaca, Morelos, 62250, Mexico
Clinical Site 40
Mexico City, 11650, Mexico
Clinical Site 44
Auckland, 1010, New Zealand
Clinical Site 43
Auckland, 2025, New Zealand
Clinical Site 45
Christchurch, 8011, New Zealand
Clinical Site 46
Muscat, Oman
Clinical Site 47
Lodz, 93-338, Poland
Clinical Site 48
Belgrade, 11000, Serbia
Clinical Site 49
Niš, 18000, Serbia
Clinical Site 50
Singapore, 119074, Singapore
Clinical Site 51
Gwangju, 61469, South Korea
Clinical Site 52
Seoul, 03080, South Korea
Clinical Site 53
A Coruña, 15001, Spain
Clinical Site 54
Granada, 18012, Spain
Clinical Site 55
Madrid, 28007, Spain
Clinical Site 56
Santiago de Compostela, 15706, Spain
Clinical Site 58
Melikgazi, Kayseri, 38030, Turkey (Türkiye)
Clinical Site 57
Izmir, 35100, Turkey (Türkiye)
Primary Completion
April 29, 2024
Actual (reported)Study Completion
April 21, 2026
Actual (reported)Last Updated
June 5, 2026
Results First Posted
February 4, 2026
Record last verified: 2026-05
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