Clinical trial • Phase III • Endocrinology

Synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues for Severe hypertriglyceridemia

Phase III trial of Synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing…

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Severe hypertriglyceridemia
Trial Stage
Phase III
Drug Modality
Oligonucleotide
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
05-06-2024
First CTIS Authorization Date
23-09-2024

Trial design

Randomised, test: aro-apoc3 pfs (plozasiran) — active investigational product (synthetic double-stranded sirna oligonucleotide directed against apolipoprotein c-iii mrna, covalently linked to tri-n-acetylgalactosamine ligand); product info: solution for injection in pre-filled syringe, route subcutaneous, dose uom mg, max daily dose 25 mg, max total dose 100 mg, max treatment period 12 (months). comparator/placebo: plozasiran injection placebo (placebo for ploza­siran).-controlled Phase III trial in Germany, Slovakia, Bulgaria and others.

Randomised
Yes
Comparator
Test: ARO-APOC3 PFS (plozasiran) — active investigational product (synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA, covalently linked to tri-N-acetylgalactosamine ligand); product info: SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, route SUBCUTANEOUS, dose UOM mg, max daily dose 25 mg, max total dose 100 mg, max treatment period 12 (months). Comparator/placebo: Plozasiran Injection Placebo (placebo for ploza­siran).
Target Sample Size
162
Trial Duration For Participant
365

Eligibility

Recruits 162 Vulnerable population selected (isVulnerablePopulationSelected = true). Informed consent is managed using subject information and informed consent forms (Main ICF and country-specific ICFs) provided for each country; there are specific ICFs for pregnant partners and optional genetic testing. Consent is obtained from adult participants (≥18 years) via the documented ICFs available in multiple country versions/languages as listed in the submission documents..

Pregnancy Exclusion
Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Informed consent is managed using subject information and informed consent forms (Main ICF and country-specific ICFs) provided for each country; there are specific ICFs for pregnant partners and optional genetic testing. Consent is obtained from adult participants (≥18 years) via the documented ICFs available in multiple country versions/languages as listed in the submission documents.

Inclusion criteria

  • {"criterion_text":"- Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening\n- Established diagnosis of SHTG and prior documented evidence (medical history) of fasting TG levels of ≥500 mg/dL (≥5.65 mmol/L)\n- Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period\n- Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening\n- Screening HbA1c ≤9.0%\n- Willing to follow diet counseling and maintain a stable low-fat diet\n- Subjects must be on standard of care lipid-and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels.)"}

Exclusion criteria

  • {"criterion_text":"- Use of any hepatocyte-targeted siRNA that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks.\n- Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer.\n- Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 hyperlipoproteinemia) by documentation of confirmed homozygote, compound heterozygote or double heterozygote for loss-of-function mutations in type 1-causing genes\n- Acute pancreatitis within 4 weeks prior to screening (S1).\n- Body mass index >45 kg/m2"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent change in fasting serum TG levels from baseline to Month 12 (V10 and V11) compared to placebo","definition_or_measurement_approach":"Percent change in fasting serum triglyceride (TG) levels measured from baseline to Month 12 (visits V10 and V11); comparison versus placebo arm."}

Secondary endpoints

  • {"endpoint_text":"- Percent change in fasting serum TG levels from baseline to Month 10 (V8 and V9) compared to placebo","definition_or_measurement_approach":"Percent change in fasting serum TG from baseline to Month 10 (visits V8 and V9) compared to placebo."}
  • {"endpoint_text":"- Proportion of subjects who achieve fasting TG levels of <500 mg/dL (<5.65 mmol/L) at Month 12 (V10 and V11) compared to placebo","definition_or_measurement_approach":"Proportion of participants with fasting TG <500 mg/dL at Month 12 (V10 and V11) compared to placebo."}
  • {"endpoint_text":"- Proportion of subjects who achieve fasting TG levels of <150 mg/dL (<1.69 mmol/L) at Month 12 (V10 and V11) compared to placebo","definition_or_measurement_approach":"Proportion of participants with fasting TG <150 mg/dL at Month 12 (V10 and V11) compared to placebo."}
  • {"endpoint_text":"- Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 (V11) compared to placebo","definition_or_measurement_approach":"Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 (visit V11) compared to placebo."}
  • {"endpoint_text":"- Percent change in non-HDL-C from baseline to Month 12 (V11) compared to placebo","definition_or_measurement_approach":"Percent change in non-HDL cholesterol from baseline to Month 12 (visit V11) compared to placebo."}
  • {"endpoint_text":"- Adjudicated AP event rate during the treatment period compared to placebo from day 1 to Month 12 (V11)","definition_or_measurement_approach":"Adjudicated acute pancreatitis (AP) event rate during treatment period (Day 1 to Month 12, visit V11) compared between plozasiran and placebo arms."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
162
Recruitment Window Months
24
Consent Approach
Informed consent obtained from adult participants (participants must be ≥18). Multiple subject information and informed consent form documents are provided (Main ICF and country-specific ICFs), including optional ICFs for genetic testing, optional FSR, and a Pregnant Partner ICF. ICFs are available in multiple country/language versions as listed in the submission (e.g., EN, BG, FR, ES, HU, LT, PL, SK, SLV variants), and consent is captured per site using the country-appropriate ICFs.

Methods

  • Digital Waiting Room Ads (digital adverts for clinic waiting rooms) — materials present (country-specific versions) for patient awareness
  • Patient Posters and Patient Brochures — printed site materials for patient-facing recruitment
  • Doctor-to-Patient Letters — site/physician outreach to inform potentially eligible patients
  • Study Hub / Setup Patient Instructions / Mobile View — online Study Hub and mobile-optimized content to support decentralized recruitment and participant onboarding
  • Pre-screening Website Content and ePR Participant Journey Emails — online pre-screening and email communication pathways to engage potential participants
  • Referral Hub and Outreach & Advertising — referral pathways and broader outreach campaigns
  • Site Posters and Talking Points Guides for site staff (site-based recruitment materials)
  • Materials are localized/country-specific (document manualVersion codes indicate country tailoring: e.g., DEU (Germany), SVK (Slovakia), BGR (Bulgaria), ESP (Spain), POL (Poland), FRA (France), CZE (Czechia), LTU (Lithuania), LVA (Latvia), HUN (Hungary), etc.)

Geography

Total Number Of Sites
72
Total Number Of Participants
138

Germany

Earliest CTIS Part Ii Submission Date
06-08-2024
Latest Decision Or Authorization Date
14-08-2025
Processing Time Days
373
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Gemeinschaftspraxis Dres. Grosskopf
Contact Person Name
Josef Grosskopf
Site Name
Charite Universitaetsmedizin Berlin KöR
Contact Person Name
Ursula Kassner
Contact Person Email
Ursula.kassner@charite.de
Site Name
Rostock University Medical Center
Department Name
Lipidambulanz, Institut für Klinische Chemie und Laboratoriumsmedizin
Contact Person Name
Elisabeth Steinhagen-Thiessen
Site Name
Smo Md GmbH
Contact Person Name
Falk Schlichthaar
Contact Person Email
fsc@smo-md.de
Site Name
Medizinisches Versorgungszentrum Jung GbR
Contact Person Name
Thomas Jung
Contact Person Email
dr.thomas.jung@drs-jung.de

Slovakia

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
11-08-2025
Processing Time Days
348
Number Of Sites
4
Number Of Participants
2

Sites

Site Name
Cardioinvest s.r.o.
Department Name
Correct Site address is Cardioamb s.r.o, M. Flengera 10, Nove Zamky 94002, Slovakia
Contact Person Name
Tibor Duris
Contact Person Email
tiborduris@pobox.sk
Site Name
Kardiovaskularne centrum s.r.o.
Department Name
Kardiologicka ambulancia
Contact Person Name
Katarina Dulkova
Contact Person Email
kardio.dul@gmail.com
Site Name
Tatratrial s.r.o.
Department Name
Ambulancia diabetologie a poruch latkovej premeny a vyzivy
Contact Person Name
Dalibor Sosovec
Contact Person Email
diarv@azet.sk
Site Name
Medispol s.r.o.
Department Name
Interna a kardiologicka ambulancia
Contact Person Name
Daniela Vinanska
Contact Person Email
dana.vinanska@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
12-08-2025
Processing Time Days
337
Number Of Sites
14
Number Of Participants
36

Sites

Site Name
Medical Center “Acad. Iv. Penchev” EOOD
Contact Person Name
Emil Nachev
Contact Person Email
enatchev@abv.bg
Site Name
UNIMED Medical Center EOOD
Contact Person Name
Mariyana Todorova Marinova
Contact Person Email
mtodorova1964@gmail.com
Site Name
Medical Center Hera EOOD
Contact Person Name
Iskren Garvanski
Site Name
Second Medical Center-Sofia Ltd.
Contact Person Name
Katerina Vitliyanova
Contact Person Email
k.vitlianova@abv.bg
Site Name
UMHAT Sofiamed OOD
Department Name
Clinic of Endocrinology and Metabolic Diseases
Contact Person Name
Anna-Maria Borissova-Ivanova
Contact Person Email
anmarbor@abv.bg
Site Name
Alexandrovska University Hospital
Department Name
Clinic of endocrinology and metabolic diseases
Contact Person Name
Zdravko Kamenov
Contact Person Email
zkamenov@hotmail.com
Site Name
Diamedical Medical Center 2013 Ltd.
Contact Person Name
Evgeni Georgiev
Contact Person Email
evgenigeorg75@gmail.com
Site Name
Medical Center Rusemed EOOD
Contact Person Name
Tsvetelina Alexandrova-Pashova
Contact Person Email
tsveti.pashova@gmail.com
Site Name
Multidisciplinary Hospital For Active Treatment Haskovo AD
Department Name
Department of Cardiology
Contact Person Name
Ivaylo Vasilev
Contact Person Email
ivovassilevmd@yahoo.com
Site Name
Medical Center Hera - Kyustendil EOOD
Contact Person Name
Borislav Kolomanov
Site Name
Kalimat Medical Center Ltd.
Contact Person Name
Tzvetan Dragoychev
Contact Person Email
dragoychev@abv.bg
Site Name
Multiprofessional Hospital For Active Treatment Iulia Vrevska-Byala EOOD
Department Name
Department of Internal diseases
Contact Person Name
Viktor Margaritov
Contact Person Email
viktormargaritov@gmail.com
Site Name
Medical Center-Sv. Dimitar EOOD
Contact Person Name
Tzvetelina Totomirova
Contact Person Email
cveti.totomirova@gmail.com
Site Name
Medical Center Zara-Med EOOD
Contact Person Name
Yanka Gineva
Contact Person Email
dr_gineva@abv.bg

Hungary

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
13-08-2025
Processing Time Days
383
Number Of Sites
7
Number Of Participants
4

Sites

Site Name
Da Vinci Spa Kft.
Contact Person Name
András Vorobcsuk
Contact Person Email
vorobcsukandras@gmail.com
Site Name
Belvarosi Egeszseghaz Kft.
Contact Person Name
Géza Lupkovics
Contact Person Email
lupkogeza@t-online.hu
Site Name
Obudai Egeszseguegyi Centrum Kft.
Contact Person Name
Andrea Várkonyi
Contact Person Email
vorobcsukandras@gmail.com
Site Name
Nyiro Gyula Orszagos Pszichiatriai es Addiktologiai Intezet
Department Name
Központi Intenzív és Aneszteziológiai Osztály
Contact Person Name
Beáta Csepregi
Contact Person Email
csepregib@nyiro-opai.hu
Site Name
IPR Hungary Kft.
Contact Person Name
Judit Hegedűs
Contact Person Email
judihegedus@gmail.com
Site Name
Belgyogyaszati es Kardiologiai Maganrendelo
Contact Person Name
Ferenc Lakatos
Contact Person Email
lakatosferenc@hotmail.com
Site Name
Coromed-Smo Kft.
Contact Person Name
Zsolt Sárszegi
Contact Person Email
sarszegizsolt@gmail.com

Lithuania

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
12-08-2025
Processing Time Days
347
Number Of Sites
7
Number Of Participants
23

Sites

Site Name
Inmedica UAB
Contact Person Name
Jolanta Elena Marcinkeviciene
Contact Person Email
jolantamar@yahoo.com
Site Name
Klinikiniai Sprendimai UAB
Contact Person Name
Rimvydas Slapikas
Contact Person Email
rimvydas.slapikas@gmail.com
Site Name
Kaunas City Polyclinic, Public Institution
Contact Person Name
Egle Urbanaviciene
Contact Person Email
egle.endo@gmail.com
Site Name
Pirmoji Viltis UAB
Contact Person Name
Nora Kupstyte-Kristapone
Contact Person Email
nora.kupstyte@yahoo.com
Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Centre of Cardiology and Angiology
Contact Person Name
Zaneta Petrulioniene
Contact Person Email
zaneta.petrulioniene@santa.lt
Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Center of Family Medicine
Contact Person Name
Lina Venceviciene
Contact Person Email
lina.venceviciene@santa.lt
Site Name
Saules seimos medicinos centras UAB
Contact Person Name
Gediminas Urbonas
Contact Person Email
g.urbonas@ssmc.lt

Latvia

Earliest CTIS Part Ii Submission Date
02-09-2024
Latest Decision Or Authorization Date
11-08-2025
Processing Time Days
343
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Pauls Stradins Clinical University Hospital
Department Name
Endocrinology
Contact Person Name
Valdis Pirags
Contact Person Email
pirags@latnet.lv
Site Name
Rutas Eglites Gimenes Arsta Prakse SIA
Department Name
Internal Medicine
Contact Person Name
Ruta Eglite
Contact Person Email
eglite_r@inbox.lv
Site Name
Daugavpils Regional Hospital SIA
Department Name
Internal medicine
Contact Person Name
Inga Morozova
Contact Person Email
merryinga@inbox.lv
Site Name
"Rīgas Austrumu klīniskā universitātes slimnīca" SIA
Department Name
Cardiology department
Contact Person Name
Aldis Strelnieks
Contact Person Email
aldis.strelnieks@aslimnica.lv
Site Name
Medispol s.r.o. (Tukums) / Inese Petrova General Practitioner Practice
Department Name
General Medicine
Contact Person Name
Inese Petrova
Contact Person Email
inese.petrova@gmail.com
Site Name
Daugavpils Regional Hospital SIA
Department Name
Cardiology
Contact Person Name
Natalja Pontaga
Contact Person Email
natalija.pontaga@inbox.lv
Site Name
Medical Centre DAP
Department Name
General Medicine
Contact Person Name
Rota Ritenberga
Contact Person Email
rota20@inbox.lv
Site Name
OLVI Medical Centre
Department Name
Pneumonology
Contact Person Name
Lilita Mitrofanova
Contact Person Email
lilita.m@inbox.eu

Poland

Earliest CTIS Part Ii Submission Date
23-08-2024
Latest Decision Or Authorization Date
18-08-2025
Processing Time Days
360
Number Of Sites
10
Number Of Participants
14

Sites

Site Name
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
Contact Person Name
Magdalena Wojanowska-Pindel
Contact Person Email
kontakt@klinikabadawcza.pl
Site Name
Indywidualna Specjalistyczna Praktyka Lekarska Włodzimierz Kuś
Contact Person Name
Włodzimierz Kuś
Contact Person Email
wlodzimierz.kus@wp.pl
Site Name
Velocity Nova Sp. z o.o.
Department Name
miejsce prowadzenia badnia: Velocity Zamość
Contact Person Name
Wojciech Czochra
Contact Person Email
wczochra@velocityclinical.com
Site Name
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Department Name
Oddział Kliniczny Kardiologii i Intensywnej Terapii Kardiologicznej
Contact Person Name
Grzegorz Skonieczny
Contact Person Email
kardiologia@wszz.torun.pl
Site Name
ZDROWIE S.C. AGNIESZKA I DONALD DROŻDŻ Kliniki Medyczne Zdrowie Wroclaw
Contact Person Name
Donald Drożdż
Contact Person Email
donalddrozdz@gmail.com
Site Name
Clinical Medical Research Sp. z o.o.
Contact Person Name
Piotr Wilczek
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Department Name
Podmiot leczniczy: Twoja Przychodnia SCM
Contact Person Name
Krzysztof Przybycień
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
Miejsce prowadzenia badania: MICS Centrum Medyczne Bydgoszcz
Contact Person Name
Wojciech Balak
Contact Person Email
wojbalak@gazeta.pl
Site Name
Pratia S.A.
Contact Person Name
Elżbieta Rosik
Contact Person Email
erosik@pratia.pl
Site Name
Wojewodzki Szpital Zespolony / other listed centres
Contact Person Name
Piotr Wilczek (additional contact listed)

France

Earliest CTIS Part Ii Submission Date
19-07-2024
Latest Decision Or Authorization Date
11-08-2025
Processing Time Days
388
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Hôpital de la Pitié Salpêtrière
Department Name
Nutrition
Contact Person Name
Antonio GALLO
Contact Person Email
antonio.gallo@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Endocrinology, Diabetology and Nutrition
Contact Person Name
Vincent RIGALLEAU
Site Name
Centre Hospitalier Saint Joseph Saint Luc
Department Name
Endocrinology and Diabetology
Contact Person Name
Lucien MARCHAND
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Cardiology
Contact Person Name
Jean-Baptiste BERNEAU
Contact Person Email
jbberneau@ch-cotebasque.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Nutrition, Metabolic diseases and Endocrinology
Contact Person Name
René VALERO
Contact Person Email
rene.valero@ap-hm.fr

Czechia

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
24-10-2025
Processing Time Days
421
Number Of Sites
8
Number Of Participants
17

Sites

Site Name
Unilabs Diagnostics k.s.
Contact Person Name
Petr Reichert
Contact Person Email
re.petr@seznam.cz
Site Name
MUDr. Jan Kvasnicka CSc
Contact Person Name
Jan Kvasnicka
Contact Person Email
jkvas@volny.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
I. Interni kardioangiologicka klinika
Contact Person Name
Vladimir Kincl
Contact Person Email
vladimir.kincl@fnusa.cz
Site Name
Kardiologicka ambulance MUDr. Ferkl s.r.o.
Contact Person Name
Richard Ferkl
Contact Person Email
ferklr@seznam.cz
Site Name
Nemocnice Slany
Department Name
Gastroenterologicka a hepatologicka ambulance
Contact Person Name
Martin Peterka
Contact Person Email
peterka.studie@seznam.cz
Site Name
Edumed s.r.o.
Contact Person Name
Jiri Vesely
Contact Person Email
vesely.edumed@gmail.com
Site Name
PreventaMed s.r.o.
Contact Person Name
Jiri Pumprla
Contact Person Email
research@vilazdravi.cz
Site Name
Additional listed Czech sites
Contact Person Name
Contacts listed in submission

Spain

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
588
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Endocrinología
Contact Person Name
José Luis Díaz
Contact Person Email
jose.luis.diaz.diaz@sergas.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Endocrinología
Contact Person Name
Agustín Blanco
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Endocrinología
Contact Person Name
Pilar Mazón Ramos
Contact Person Email
Pilar.Mazon.Ramos@sergas.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Endocrinología
Contact Person Name
Aurora González
Contact Person Email
aurora.gonzalez.e@gmail.com

Sponsor

Primary sponsor

Full Name
Arrowhead Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
IQVIA Limited
Responsibilities
Responsibilities coded: 1,10,11,12,13,2,5,6,8 (as listed in submission)
Name
Suvoda LLC
Responsibilities
Responsibilities coded: 3 (as listed in submission)
Name
Medpace Reference Laboratories LLC
Responsibilities
Biomarker analysis

Third parties

  • {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"Antibody testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"Biomarker analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Canada","full_name":"The University Of Western Ontario","duties_or_roles":"Genetic testing","organisation_type":"Educational Institution"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Responsibilities coded: 1,10,11,12,13,2,5,6,8 (as listed in submission)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Keystone Bioanalytical Inc.","duties_or_roles":"PK testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Sharp Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Manufacturing Packaging Farmaca (MPF) B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
ARO-APOC3 PFS
Active Substance
Synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues
Modality
Oligonucleotide
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (prodAuthStatus = 1)
Orphan Designation
Yes
Maximum Dose
100 mg total; max daily dose 25 mg
Investigational Product Name
Plozasiran Injection Placebo
Modality
Other

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