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 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
Hypertriglyceridemia
Trial Stage
Phase III
Drug Modality
Oligonucleotide

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
07-10-2024

Trial design

Randomised, plozasiran injection placebo (placebo comparator arm). active investigational product: aro-apoc3 pfs (subcutaneous). dose/schedule for placebo not specified in the provided data; product metadata for aro-apoc3 pfs lists max daily dose 25 mg and max total dose 100 mg but no explicit dosing schedule is provided.-controlled Phase III trial in Germany, Hungary, France and others.

Randomised
Yes
Comparator
Plozasiran Injection Placebo (placebo comparator arm). Active investigational product: ARO-APOC3 PFS (subcutaneous). Dose/schedule for placebo not specified in the provided data; product metadata for ARO-APOC3 PFS lists max daily dose 25 mg and max total dose 100 mg but no explicit dosing schedule is provided.
Target Sample Size
978
Trial Duration For Participant
365

Eligibility

Recruits 978 Vulnerable population flag is selected in trial metadata. Specific details on consent/assent handling are not provided in the JSON; subject information sheets and informed consent forms are listed for multiple countries (indicating formal ICF procedures), but explicit description of assent/consent procedures for vulnerable groups is not available in the provided data..

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 flag is selected in trial metadata. Specific details on consent/assent handling are not provided in the JSON; subject information sheets and informed consent forms are listed for multiple countries (indicating formal ICF procedures), but explicit description of assent/consent procedures for vulnerable groups is not available in the provided data.

Inclusion criteria

  • {"criterion_text":"- Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening"}
  • {"criterion_text":"- Established diagnosis of HTG and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L)"}
  • {"criterion_text":"- Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 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"}
  • {"criterion_text":"- Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening"}
  • {"criterion_text":"- Screening HbA1c ≤9.0%"}
  • {"criterion_text":"- Willing to follow diet counseling and maintain a stable low-fat diet"}
  • {"criterion_text":"- 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 due to 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 TGs 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Acute pancreatitis within 4 weeks prior to screening (S1)"}
  • {"criterion_text":"- Body mass index (BMI) >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 from baseline to Month 12 assessed at visits V10 and V11; compared versus placebo."}

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 levels from baseline to Month 10 assessed at visits V8 and V9; compared versus 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 achieving fasting TG <150 mg/dL at Month 12 (V10 and V11); comparison versus 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 (V11); compared versus 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-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Month 12 (V11); compared versus placebo."}

Recruitment

Digital Remote Recruitment
True — digital/remote methods are explicitly included (Study Hub with mobile view, pre-screening website content, ePR participant journey emails, Study Hub setup instructions and mobile views).
Planned Sample Size
978
Recruitment Window Months
23
Consent Approach
Informed consent is obtained using subject information sheets and informed consent forms (ICFs). Country-specific ICFs and related documents are provided (multiple versions/manual versions in languages for Germany (DEU), Hungary (HUN), Poland (POL), Slovakia (SVK), Czechia (CZE), Spain (ESP), Bulgaria (BGR), France (FRA), Italy (ITA) and English). Optional consent modules are listed (e.g., optional genetic testing ICF, optional FSR ICF, pregnant partner ICF, privacy/GDPR ICF), indicating separate consent options for specific procedures. Participants are adults (≥18) and therefore provide informed consent themselves; detailed assent procedures for minors are not applicable/are not described.

Methods

  • Doctor-to-Patient Letter (site-mediated recruitment via treating physicians).
  • Patient Brochure (print/digital informational brochure for potential participants).
  • Patient Poster (posters for display in clinics/sites to inform patients).
  • Study Hub (digital platform) including Setup Patient Instructions, Tip Sheet, Mobile View — used for decentralized recruitment and participant support.
  • ePR Participant Journey Emails (electronic participant emails to guide pre-screening/enrolment).
  • Pre-screening Website Content (online pre-screening tool/content to capture potential participants).
  • Patient ID Card and Thank You Card (site-provided materials to enrolled participants).
  • CRS (Clinical Research Staff) Brochure and other site-facing materials to support recruitment.

Geography

Total Number Of Sites
102
Total Number Of Participants
478

Germany

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
519
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Smo Md GmbH
Principal Investigator Name
Falk Schlichthaar
Principal Investigator Email
fsc@smo-md.de
Contact Person Name
Falk Schlichthaar
Contact Person Email
fsc@smo-md.de
Site Name
Gemeinschaftspraxis Dres. Grosskopf
Principal Investigator Name
Wilma Grosskopf
Principal Investigator Email
Dr.w.grosskopf@drs-grosskopf.de
Contact Person Name
Wilma Grosskopf
Site Name
Medizinisches Versorgungszentrum Jung GbR
Principal Investigator Name
Thomas Jung
Principal Investigator Email
dr.thomas.jung@drs-jung.de
Contact Person Name
Thomas Jung
Contact Person Email
dr.thomas.jung@drs-jung.de

Hungary

Earliest CTIS Part Ii Submission Date
15-08-2024
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
517
Number Of Sites
13
Number Of Participants
53

Sites

Site Name
Minoseg Orvoscsoport Kft.
Department Name
-
Principal Investigator Name
Margit Miléder
Principal Investigator Email
mileder.margit@gmail.com
Contact Person Name
Margit Miléder
Contact Person Email
mileder.margit@gmail.com
Site Name
Clinexpert Kft.
Department Name
-
Principal Investigator Name
Tamás Bárány
Principal Investigator Email
drbaranytamas@gmail.com
Contact Person Name
Tamás Bárány
Contact Person Email
drbaranytamas@gmail.com
Site Name
Belvaros-Lipotvaros Egeszseguegyi Szolgalat
Department Name
Belgyógyaszat-Kardiológia
Principal Investigator Name
Andrea Tumpek
Principal Investigator Email
tumpeka18@gmail.com
Contact Person Name
Andrea Tumpek
Contact Person Email
tumpeka18@gmail.com
Site Name
Obudai Egeszseguegyi Centrum Kft.
Department Name
-
Principal Investigator Name
Andrea Várkonyi
Principal Investigator Email
andrea.varkonyi@oec.hu
Contact Person Name
Andrea Várkonyi
Contact Person Email
andrea.varkonyi@oec.hu
Site Name
IPR Hungary Kft.
Department Name
-
Principal Investigator Name
Judit Hegedűs
Principal Investigator Email
judihegedus@gmail.com
Contact Person Name
Judit Hegedűs
Contact Person Email
judihegedus@gmail.com
Site Name
University Of Szeged
Department Name
Szent-Györgyi Albert Klinikai Központ, Családorvosi Intézet és Rendelő
Principal Investigator Name
Albert Varga
Principal Investigator Email
varga.albert@med.u-szeged.hu
Contact Person Name
Albert Varga
Contact Person Email
varga.albert@med.u-szeged.hu
Site Name
Belvarosi Egeszseghaz Kft.
Department Name
-
Principal Investigator Name
Géza Lupkovics
Principal Investigator Email
lupkogeza@t-online.hu
Contact Person Name
Géza Lupkovics
Contact Person Email
lupkogeza@t-online.hu
Site Name
Nyírő Gyula Országos Pszichiátriai es Addiktológiai Intézet
Department Name
Központi Intenzív es Aneszteziológiai Osztály
Principal Investigator Name
Beáta Csepregi
Principal Investigator Email
csepregib@nyiro-opai.hu
Contact Person Name
Beáta Csepregi
Contact Person Email
csepregib@nyiro-opai.hu
Site Name
Privat Doktor Egeszseguegyi Szolgaltato Zrt.
Department Name
-
Principal Investigator Name
András Vértes
Principal Investigator Email
andrasvertes.smo@gmail.com
Contact Person Name
András Vértes
Contact Person Email
andrasvertes.smo@gmail.com
Site Name
Belgyógyászati es Kardiológiai Magánrendelő
Department Name
-
Principal Investigator Name
Ferenc Lakatos
Principal Investigator Email
lakatosferenc@hotmail.com
Contact Person Name
Ferenc Lakatos
Contact Person Email
lakatosferenc@hotmail.com
Site Name
Uno Medical Trials Kft.
Department Name
-
Principal Investigator Name
Nikosz Kanakaridisz
Principal Investigator Email
kanakaridisznikosz@unomedicaltrials.hu
Contact Person Name
Nikosz Kanakaridisz
Site Name
Coromed-Smo Kft.
Department Name
-
Principal Investigator Name
Zsolt Sárszegi
Principal Investigator Email
sarszegizsolt@gmail.com
Contact Person Name
Zsolt Sárszegi
Contact Person Email
sarszegizsolt@gmail.com
Site Name
Da Vinci Spa Kft.
Department Name
-
Principal Investigator Name
András Vorobcsuk
Principal Investigator Email
vorobcsukandras@gmail.com
Contact Person Name
András Vorobcsuk
Contact Person Email
vorobcsukandras@gmail.com

France

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
530
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Endocrinology
Principal Investigator Name
René VALERO
Principal Investigator Email
RVALERO@mail.ap-hm.fr
Contact Person Name
René VALERO
Contact Person Email
RVALERO@mail.ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Endocrinology
Principal Investigator Name
Vincent RIGALLEAU
Principal Investigator Email
vincent.rigalleau@chu-bordeaux.fr
Contact Person Name
Vincent RIGALLEAU
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Lipidology
Principal Investigator Name
Antonio GALLO
Principal Investigator Email
Antonio.gallo@aphp.fr
Contact Person Name
Antonio GALLO
Contact Person Email
Antonio.gallo@aphp.fr
Site Name
Centre Hospitalier Saint Joseph Saint Luc
Department Name
Endocrinology
Principal Investigator Name
Lucien MARCHAND
Principal Investigator Email
lmarchand@saintjosephsaintluc.fr
Contact Person Name
Lucien MARCHAND

Italy

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
568
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Centro Dislipidemie
Principal Investigator Name
Giuliana Germana Mombelli
Principal Investigator Email
giuliana.mombelli@ospedaleniguarda.it
Contact Person Name
Giuliana Germana Mombelli
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
UOC Astanteria MCAU
Principal Investigator Name
Angelo Baldassare Cefalù
Principal Investigator Email
abaldassare.cefalu@unipa.it
Contact Person Name
Angelo Baldassare Cefalù
Contact Person Email
abaldassare.cefalu@unipa.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
UO Endocrinologia, Diabetologia, Andrologia
Principal Investigator Name
Marco Mirani
Principal Investigator Email
marco.mirani@humanitas.it
Contact Person Name
Marco Mirani
Contact Person Email
marco.mirani@humanitas.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical and Surgical Sciences Department
Principal Investigator Name
Arrigo Francesco Giuseppe Cicero
Principal Investigator Email
arrigo.cicero@unibo.it
Contact Person Name
Arrigo Francesco Giuseppe Cicero
Contact Person Email
arrigo.cicero@unibo.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Cardiologia
Principal Investigator Name
Savina Nodari
Principal Investigator Email
savina.nodari@unibs.it
Contact Person Name
Savina Nodari
Contact Person Email
savina.nodari@unibs.it

Poland

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
497
Number Of Sites
19
Number Of Participants
131

Sites

Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Department Name
Podmiot leczniczy: Twoja Przychodnia
Principal Investigator Name
Krzysztof Przybycien
Principal Investigator Email
przybycien@twojaprzychodnia.com
Contact Person Name
Krzysztof Przybycien
Site Name
Futuremeds Sp. z o.o. (Wroclaw)
Department Name
Site name: FutureMeds Wroclaw
Principal Investigator Name
Paulina Ludziak
Principal Investigator Email
paulina.ludziak@futuremeds.com
Contact Person Name
Paulina Ludziak
Contact Person Email
paulina.ludziak@futuremeds.com
Site Name
Clinical Medical Research Sp. z o.o.
Principal Investigator Name
Piotr Wilczek
Principal Investigator Email
p.wilczek@clinicalmedicalresearch.pl
Contact Person Name
Piotr Wilczek
Site Name
Futuremeds Sp. z o.o. (Lódź)
Department Name
Site name: FutureMeds Lódź
Principal Investigator Name
Katarzyna Bartnicka-Maslowska
Principal Investigator Email
katarzyna.bartnicka@amed.med.pl
Contact Person Name
Katarzyna Bartnicka-Maslowska
Site Name
Futuremeds Sp. z o.o. (Warszawa Centrum)
Department Name
Site name: FutureMeds Warszawa Centrum
Principal Investigator Name
Magda Fliszkiewicz
Principal Investigator Email
magda.fliszkiewicz@futuremeds.com
Contact Person Name
Magda Fliszkiewicz
Site Name
Pratia S.A.
Department Name
Site name: Pratia MCM Kraków
Principal Investigator Name
Magdalena Marzec
Principal Investigator Email
magdalena.marzec@pratia.com
Contact Person Name
Magdalena Marzec
Contact Person Email
magdalena.marzec@pratia.com
Site Name
Centrum Medyczne Serafin med
Principal Investigator Name
Ryszard Serafin
Principal Investigator Email
ryszard.serafin@op.pl
Contact Person Name
Ryszard Serafin
Contact Person Email
ryszard.serafin@op.pl
Site Name
Sedimed Sp. z o.o.
Department Name
Site name: CM Sedimed Wrocław
Principal Investigator Name
Anna Bienkiewicz
Principal Investigator Email
biuro@sedimed.pl
Contact Person Name
Anna Bienkiewicz
Contact Person Email
biuro@sedimed.pl
Site Name
Zdrowie S.C. Agnieszka i Donald Drozdz
Principal Investigator Name
Donald Drozdz
Principal Investigator Email
donalddrozdz@gmail.com
Contact Person Name
Donald Drozdz
Contact Person Email
donalddrozdz@gmail.com
Site Name
Futuremeds Sp. z o.o. (Targówek)
Department Name
Site name: FutureMeds Targówek
Principal Investigator Name
Agnieszka Jurek-Urbanowska
Principal Investigator Email
agnieszka.urbanowska@futuremeds.com
Contact Person Name
Agnieszka Jurek-Urbanowska
Site Name
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
Principal Investigator Name
Magdalena Wojanowska-Pindel
Principal Investigator Email
m.wojanowska-pindel@klinikabadawcza.pl
Contact Person Name
Magdalena Wojanowska-Pindel
Site Name
Ko-Med Centra Kliniczne Sp. z o.o.
Department Name
Site name: VELOCITY Zamość
Principal Investigator Name
Wojciech Czochra
Principal Investigator Email
wojciech.czochra@komed-ck.pl
Contact Person Name
Wojciech Czochra
Contact Person Email
wojciech.czochra@komed-ck.pl
Site Name
Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus
Principal Investigator Name
Wlodzimierz Kus
Principal Investigator Email
wlodzimierz.kus@wp.pl
Contact Person Name
Wlodzimierz Kus
Contact Person Email
wlodzimierz.kus@wp.pl
Site Name
Krakowskie Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Piotr Rozpondek
Principal Investigator Email
piotr.rozpondek@futuremeds.com
Contact Person Name
Piotr Rozpondek
Contact Person Email
piotr.rozpondek@futuremeds.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
Site name: MICS Centrum Medyczne Bydgoszcz
Principal Investigator Name
Wojciech Balak
Principal Investigator Email
wojbalak@gazeta.pl
Contact Person Name
Wojciech Balak
Contact Person Email
wojbalak@gazeta.pl
Site Name
Pratia S.A. (Gdynia)
Department Name
Site name: Centrum Medyczne Pratia Gdynia
Principal Investigator Name
Elżbieta Rosik
Principal Investigator Email
erosik@pratia.pl
Contact Person Name
Elżbieta Rosik
Contact Person Email
erosik@pratia.pl
Site Name
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Department Name
Site name: NZOZ Centrum Medyczne KERmed
Principal Investigator Name
Tomasz Ługowski
Principal Investigator Email
tomasz.lugowski@gmail.com
Contact Person Name
Tomasz Ługowski
Contact Person Email
tomasz.lugowski@gmail.com
Site Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Principal Investigator Name
Bożena Gornikiewicz-Brzezicka
Principal Investigator Email
b.gornikiewicz-brzezicka@ckb.elblag.pl
Contact Person Name
Bożena Gornikiewicz-Brzezicka
Site Name
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Department Name
Oddział Kliniczny Kardiologii i Intensywnej Terapii Kardiologicznej
Principal Investigator Name
Grzegorz Skonieczny
Principal Investigator Email
grzegorz.skonieczny@onet.eu
Contact Person Name
Grzegorz Skonieczny
Contact Person Email
grzegorz.skonieczny@onet.eu

Slovakia

Earliest CTIS Part Ii Submission Date
05-09-2024
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
494
Number Of Sites
10
Number Of Participants
49

Sites

Site Name
Tatratrial s.r.o.
Department Name
Ambulancia diabetologie a poruch latkovej premeny a vyzivy
Principal Investigator Name
Dalibor Sosovec
Principal Investigator Email
diarv@azet.sk
Contact Person Name
Dalibor Sosovec
Contact Person Email
diarv@azet.sk
Site Name
Medical group Kosice s.r.o.
Department Name
Kardiologicka a interna ambulacia
Principal Investigator Name
Ivan Majercak
Principal Investigator Email
majercak@medicalgroup.sk
Contact Person Name
Ivan Majercak
Contact Person Email
majercak@medicalgroup.sk
Site Name
Medispol s.r.o.
Department Name
Interna a kardiologicka ambulancia
Principal Investigator Name
Daniela Vinanska
Principal Investigator Email
dana.vinanska@gmail.com
Contact Person Name
Daniela Vinanska
Contact Person Email
dana.vinanska@gmail.com
Site Name
Cliniq s.r.o.
Department Name
Kardiologicka ambulancia
Principal Investigator Name
Alena Ftacnikova
Principal Investigator Email
ftacnikova@polibez.sk
Contact Person Name
Alena Ftacnikova
Contact Person Email
ftacnikova@polibez.sk
Site Name
Medi M&M s.r.o.
Department Name
Kardiologicka ambulancia
Principal Investigator Name
Michal Banik
Principal Investigator Email
banik.michal@gmail.com
Contact Person Name
Michal Banik
Contact Person Email
banik.michal@gmail.com
Site Name
Cardioinvest s.r.o.
Department Name
Correct site address is Cardioamb s.r.o., M.Flengera 10, Nove Zamky, 940 02, Slovakia
Principal Investigator Name
Tibor Duris
Principal Investigator Email
tiborduris@pobox.sk
Contact Person Name
Tibor Duris
Contact Person Email
tiborduris@pobox.sk
Site Name
Alian s.r.o.
Department Name
Kardiologicka ambulancia
Principal Investigator Name
Andrej Dzupina
Principal Investigator Email
dzupina@alian.sk
Contact Person Name
Andrej Dzupina
Contact Person Email
dzupina@alian.sk
Site Name
Kardiovaskularne centrum s.r.o.
Department Name
Kardiologicka ambulancia
Principal Investigator Name
Katarina Dulkova
Principal Investigator Email
kardiodul@gmail.com
Contact Person Name
Katarina Dulkova
Contact Person Email
kardiodul@gmail.com
Site Name
Kardiointerna s.r.o.
Department Name
Kardiologicka ambulancia
Principal Investigator Name
Peter Kurray
Principal Investigator Email
p.kurray@gmail.com
Contact Person Name
Peter Kurray
Contact Person Email
p.kurray@gmail.com
Site Name
Medivasa s.r.o.
Department Name
Angiologicka ambulancia
Principal Investigator Name
Viliam Bugan
Principal Investigator Email
bugan@medivasa.sk
Contact Person Name
Viliam Bugan
Contact Person Email
bugan@medivasa.sk

Bulgaria

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
535
Number Of Sites
26
Number Of Participants
124

Sites

Site Name
Medical Center Hera - Kyustendil EOOD
Principal Investigator Name
Borislav Kolomanov
Principal Investigator Email
borislav.kolomanov@heraclinics.com
Contact Person Name
Borislav Kolomanov
Site Name
Multidisciplinary Hospital For Active Treatment Haskovo AD
Department Name
Department of Cardiology
Principal Investigator Name
Ivaylo Vasilev
Principal Investigator Email
ivovassilevmd@yahoo.com
Contact Person Name
Ivaylo Vasilev
Contact Person Email
ivovassilevmd@yahoo.com
Site Name
Alexandrovska University Hospital
Department Name
Clinic of endocrinology and metabolic diseases
Principal Investigator Name
Zdravko Kamenov
Principal Investigator Email
zkamenov@hotmail.com
Contact Person Name
Zdravko Kamenov
Contact Person Email
zkamenov@hotmail.com
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Clinic of endocrinology and metabolic diseases for the treatment of metabolic disorders
Principal Investigator Name
Daniela Popova
Principal Investigator Email
dr.daniela.popova@gmail.com
Contact Person Name
Daniela Popova
Contact Person Email
dr.daniela.popova@gmail.com
Site Name
Multispecialty hospital for active treatment Sveta Sofia EOOD
Department Name
Department of Cardiology
Principal Investigator Name
Boyan Hristovski
Principal Investigator Email
bojanhristovski@yahoo.com
Contact Person Name
Boyan Hristovski
Contact Person Email
bojanhristovski@yahoo.com
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD (second contact)
Department Name
Clinic of Cardiology
Principal Investigator Name
Radostina Ilieva
Principal Investigator Email
radostilieva@yahoo.com
Contact Person Name
Radostina Ilieva
Contact Person Email
radostilieva@yahoo.com
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department Name
Department of Cardiology
Principal Investigator Name
Peyo Zhivkov
Principal Investigator Email
p.simeonov@mbalpuls.bg
Contact Person Name
Peyo Zhivkov
Contact Person Email
p.simeonov@mbalpuls.bg
Site Name
Medical Center Zara-Med EOOD
Principal Investigator Name
Yanka Gineva
Principal Investigator Email
yanka.gineva@mail.bg
Contact Person Name
Yanka Gineva
Contact Person Email
yanka.gineva@mail.bg
Site Name
Diamedical Medical Center 2013 Ltd.
Principal Investigator Name
Evgeni Georgiev
Principal Investigator Email
evgenigeorg75@gmail.com
Contact Person Name
Evgeni Georgiev
Contact Person Email
evgenigeorg75@gmail.com
Site Name
Kalimat Medical Center Ltd.
Principal Investigator Name
Tzvetan Dragoychev
Principal Investigator Email
dragoychev@abv.bg
Contact Person Name
Tzvetan Dragoychev
Contact Person Email
dragoychev@abv.bg
Site Name
Medical Center-Sv. Dimitar EOOD
Principal Investigator Name
Tzvetelina Totomirova
Principal Investigator Email
cveti.totomirova@gmail.com
Contact Person Name
Tzvetelina Totomirova
Contact Person Email
cveti.totomirova@gmail.com
Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
Clinic of cardiology
Principal Investigator Name
Yana Simova
Principal Investigator Email
ianasimova@gmail.com
Contact Person Name
Yana Simova
Contact Person Email
ianasimova@gmail.com
Site Name
Diagnostics And Consultation Center Convex Ltd.
Principal Investigator Name
Stefan Naydenov
Principal Investigator Email
snaydenov@gmail.com
Contact Person Name
Stefan Naydenov
Contact Person Email
snaydenov@gmail.com
Site Name
University Multidisciplinary Hospital for Active Treatment Sveta Ekaterina EAD
Department Name
Clinic of Cardiology
Principal Investigator Name
Borislav Atzev
Principal Investigator Email
dr.borislav.atzev@gmail.com
Contact Person Name
Borislav Atzev
Contact Person Email
dr.borislav.atzev@gmail.com
Site Name
Medical Center Hera EOOD
Principal Investigator Name
Iskren Garvanski
Principal Investigator Email
iskren.garvanski@heraclinics.com
Contact Person Name
Iskren Garvanski
Site Name
Medical Center Medconsult Pleven OOD
Principal Investigator Name
Maria Tzekova
Principal Investigator Email
mariatzekova@abv.bg
Contact Person Name
Maria Tzekova
Contact Person Email
mariatzekova@abv.bg
Site Name
Medical center 4LIFE Ltd.
Principal Investigator Name
Ismed Mehmedov
Principal Investigator Email
dr.mehmedov@gmail.com
Contact Person Name
Ismed Mehmedov
Contact Person Email
dr.mehmedov@gmail.com
Site Name
Medical Center Rusemed EOOD
Principal Investigator Name
Tsvetelina Alexandrova-Pashova
Principal Investigator Email
tsveti.pashova@gmail.com
Contact Person Name
Tsvetelina Alexandrova-Pashova
Contact Person Email
tsveti.pashova@gmail.com
Site Name
Second Medical Center-Sofia Ltd.
Principal Investigator Name
Katerina Vitliyanova
Principal Investigator Email
k.vitlianova@abv.bg
Contact Person Name
Katerina Vitliyanova
Contact Person Email
k.vitlianova@abv.bg
Site Name
Multiprofessional Hospital For Active Treatment Iulia Vrevska-Byala EOOD
Department Name
Department of internal diseases
Principal Investigator Name
Viktor Margaritov
Principal Investigator Email
viktormargaritov@gmail.com
Contact Person Name
Viktor Margaritov
Contact Person Email
viktormargaritov@gmail.com
Site Name
MBAL Sveta Karidad EAD
Department Name
Department of Cardiology
Principal Investigator Name
Ivan Manukov
Principal Investigator Email
manoukov@hotmail.com
Contact Person Name
Ivan Manukov
Contact Person Email
manoukov@hotmail.com
Site Name
UNIMED Medical Center EOOD
Principal Investigator Name
Mariyana Marinova
Principal Investigator Email
mtodorova1964@gmail.com
Contact Person Name
Mariyana Marinova
Contact Person Email
mtodorova1964@gmail.com
Site Name
UMHAT Sofiamed OOD
Department Name
Clinic of Endocrinology and Metabolic Diseases
Principal Investigator Name
Anna-Maria Borissova-Ivanova
Principal Investigator Email
anmarbor@abv.bg
Contact Person Name
Anna-Maria Borissova-Ivanova
Contact Person Email
anmarbor@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Clinic of Endocrinology and Metabolic Diseases
Principal Investigator Name
Georgi Levterov
Principal Investigator Email
glevterov@yahoo.com
Contact Person Name
Georgi Levterov
Contact Person Email
glevterov@yahoo.com
Site Name
Mbal Lyulin EAD
Department Name
Department of internal diseases
Principal Investigator Name
Stanislav Tsenov
Principal Investigator Email
steve58@abv.bg
Contact Person Name
Stanislav Tsenov
Contact Person Email
steve58@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Pulmed Ltd.
Department Name
Department of endocrinology and metabolic diseases at the Clinic of internal diseases
Principal Investigator Name
Mitko Mitkov
Principal Investigator Email
mitko_mitkov@yahoo.com
Contact Person Name
Mitko Mitkov
Contact Person Email
mitko_mitkov@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
487
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
Cardiology
Principal Investigator Name
Clara Bonanad Lozano
Principal Investigator Email
clarabonanad@gmail.com
Contact Person Name
Clara Bonanad Lozano
Contact Person Email
clarabonanad@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Cardiology
Principal Investigator Name
Jose Ramon Gonzalez Juanatey
Principal Investigator Email
jose.ramon.gonzalez.juanatey@sergas.es
Contact Person Name
Jose Ramon Gonzalez Juanatey
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Cardiology
Principal Investigator Name
Estíbaliz Jarauta
Principal Investigator Email
estijarauta@gmail.com
Contact Person Name
Estíbaliz Jarauta
Contact Person Email
estijarauta@gmail.com
Site Name
Hospital Quironsalud Barcelona
Department Name
Internal Medicine
Principal Investigator Name
Fernando Cereto Castro
Principal Investigator Email
fernando.cereto@quironsalud.es
Contact Person Name
Fernando Cereto Castro
Contact Person Email
fernando.cereto@quironsalud.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Internal Medicine
Principal Investigator Name
Jose Luiz Diaz Diaz
Principal Investigator Email
jose.luis.diaz.diaz@sergas.es
Contact Person Name
Jose Luiz Diaz Diaz
Contact Person Email
jose.luis.diaz.diaz@sergas.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Internal Medicine
Principal Investigator Name
Agustin Blanco Echevarria
Principal Investigator Email
ablanco2000es@yahoo.es
Contact Person Name
Agustin Blanco Echevarria
Contact Person Email
ablanco2000es@yahoo.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Endocrinology
Principal Investigator Name
Angel Michael Ortiz Zuñiga
Principal Investigator Email
angelmichael.ortiz@vallhebron.cat
Contact Person Name
Angel Michael Ortiz Zuñiga

Czechia

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
491
Number Of Sites
15
Number Of Participants
79

Sites

Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
I. Interni kardioangiologicka klinika
Principal Investigator Name
Vladimir Kincl
Principal Investigator Email
vladimir.kincl@fnusa.cz
Contact Person Name
Vladimir Kincl
Contact Person Email
vladimir.kincl@fnusa.cz
Site Name
MUDr. Jan Kvasnicka CSc
Principal Investigator Name
Jan Kvasnicka
Principal Investigator Email
jkvas@volny.cz
Contact Person Name
Jan Kvasnicka
Contact Person Email
jkvas@volny.cz
Site Name
CCR Ostrava s.r.o.
Principal Investigator Name
Sylva Brtnikova
Principal Investigator Email
sylva.brtnikova@ccrostrava.com
Contact Person Name
Sylva Brtnikova
Contact Person Email
sylva.brtnikova@ccrostrava.com
Site Name
PreventaMed s.r.o.
Principal Investigator Name
Jiri Pumprla
Principal Investigator Email
research@vilazdravi.cz
Contact Person Name
Jiri Pumprla
Contact Person Email
research@vilazdravi.cz
Site Name
CTC Hodonin s.r.o.
Principal Investigator Name
Jiri Matuska
Principal Investigator Email
jiri.matuska@matmed.cz
Contact Person Name
Jiri Matuska
Contact Person Email
jiri.matuska@matmed.cz
Site Name
Unilabs Diagnostics k.s.
Department Name
Lipidova poradna
Principal Investigator Name
Petr Reichert
Principal Investigator Email
re.petr@seznam.cz
Contact Person Name
Petr Reichert
Contact Person Email
re.petr@seznam.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
III. interni gerontometabolicka klinika
Principal Investigator Name
Vladimir Blaha
Principal Investigator Email
blaha@lfhk.cuni.cz
Contact Person Name
Vladimir Blaha
Contact Person Email
blaha@lfhk.cuni.cz
Site Name
Edumed s.r.o.
Principal Investigator Name
Jiri Vesely
Principal Investigator Email
vesely.edumed@gmail.com
Contact Person Name
Jiri Vesely
Contact Person Email
vesely.edumed@gmail.com
Site Name
Nemocnice Slany
Department Name
Gastroenterologicka a hepatologicka ambulance
Principal Investigator Name
Martin Peterka
Principal Investigator Email
peterka.studie@seznam.cz
Contact Person Name
Martin Peterka
Contact Person Email
peterka.studie@seznam.cz
Site Name
Diaint spol. s r.o.
Principal Investigator Name
Rene Turcinek
Principal Investigator Email
rene.turcinek@volny.cz
Contact Person Name
Rene Turcinek
Contact Person Email
rene.turcinek@volny.cz
Site Name
Krajska zdravotni a.s.
Department Name
Interni oddeleni
Principal Investigator Name
Jakub Sveceny
Principal Investigator Email
jakub.sveceny@kzcr.eu
Contact Person Name
Jakub Sveceny
Contact Person Email
jakub.sveceny@kzcr.eu
Site Name
Fakultni Thomayerova nemocnice
Department Name
Centrum kardiovaskularni prevence 1. LF UK a FTN
Principal Investigator Name
Renata Cifkova
Principal Investigator Email
renata.cifkova@ftn.cz
Contact Person Name
Renata Cifkova
Contact Person Email
renata.cifkova@ftn.cz
Site Name
Kardiologicka ambulance MUDr. Ferkl s.r.o.
Principal Investigator Name
Richard Ferkl
Principal Investigator Email
ferklr@seznam.cz
Contact Person Name
Richard Ferkl
Contact Person Email
ferklr@seznam.cz
Site Name
Institute For Clinical And Experimental Medicine
Department Name
Pracoviste preventivni kardiologie
Principal Investigator Name
Vera Adamkova
Principal Investigator Email
vera.adamkova@ikem.cz
Contact Person Name
Vera Adamkova
Contact Person Email
vera.adamkova@ikem.cz
Site Name
Medical Plus s.r.o.
Principal Investigator Name
Eva Dokoupilova
Principal Investigator Email
evadokoupil@gmail.com
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@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
Multiple sponsor duties/codes including study management functions (listed codes in sponsorDuties array)
Name
Suvoda LLC
Responsibilities
Code 3 (sponsorDuties)
Name
Medidata Solutions Inc.
Responsibilities
Code 7 (sponsorDuties)

Third parties

  • {"country":"Netherlands","full_name":"Manufacturing Packaging Farmaca (MPF) B.V.","duties_or_roles":"[{\"id\":832323,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"Biomarkers analysis (code 15)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"[{\"id\":832324,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"[{\"id\":832310,\"code\":\"1\"},{\"id\":832311,\"code\":\"10\"},{\"id\":832312,\"code\":\"11\"},{\"id\":832313,\"code\":\"12\"},{\"id\":832314,\"code\":\"13\"},{\"id\":832315,\"code\":\"14\"},{\"id\":832316,\"code\":\"2\"},{\"id\":832317,\"code\":\"5\"},{\"id\":832318,\"code\":\"6\"},{\"id\":832319,\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"[{\"id\":832320,\"code\":\"3\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"Antidrug Antibody Testing (code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Sharp Corp.","duties_or_roles":"[{\"id\":832321,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"[{\"id\":832308,\"code\":\"7\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"The University Of Western Ontario","duties_or_roles":"Genetic testing (code 15)","organisation_type":"Educational Institution"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement (code 15)","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
Maximum Dose
maxDailyDoseAmount 25 mg; maxTotalDoseAmount 100 mg
Investigational Product Name
Plozasiran Injection Placebo
Modality
Other

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