Clinical trial • Phase III • Endocrinology
Synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a GalNAc ligand (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 GalNAc ligand (th…
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, placebo (plozasiran injection placebo) comparator arm; specific placebo product named 'plozasiran injection placebo' (no dose/schedule specified in the ctis part i data).-controlled Phase III trial in Romania, Spain, Italy and others.
- Randomised
- Yes
- Comparator
- Placebo (Plozasiran Injection Placebo) comparator arm; specific placebo product named 'Plozasiran Injection Placebo' (no dose/schedule specified in the CTIS Part I data).
- Target Sample Size
- 276
- Trial Duration For Participant
- 365
Eligibility
Recruits 276 Vulnerable population is selected in the application. Informed consent is documented via subject information and informed consent forms; multiple country-specific ICFs are provided (main ICF, pregnant partner ICF, pregnant subject ICF, optional genetic testing ICF, optional FSR ICF, etc.). Participants are adults (≥18) and provide consent themselves; documents available in multiple local languages for participating Member States. No assent procedures for minors are provided in the submission materials..
- 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 is selected in the application. Informed consent is documented via subject information and informed consent forms; multiple country-specific ICFs are provided (main ICF, pregnant partner ICF, pregnant subject ICF, optional genetic testing ICF, optional FSR ICF, etc.). Participants are adults (≥18) and provide consent themselves; documents available in multiple local languages for participating Member States. No assent procedures for minors are provided in the submission materials.
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 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 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 from baseline to Month 12 (visits V10 and V11) compared with 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 (visits V8 and V9) compared with 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 subjects with fasting TG <500 mg/dL at Month 12 (V10 and V11) compared with 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 subjects with fasting TG <150 mg/dL at Month 12 (V10 and V11) compared with 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) vs 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) vs placebo."}
- {"endpoint_text":"- Adjudicated AP event rate during the treatment period compared to placebo from day 1 to at Month 12 (V11)","definition_or_measurement_approach":"Adjudicated acute pancreatitis (AP) event rate during treatment from Day 1 through Month 12 (V11) compared between treatment and placebo."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 276
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent obtained from each participant (participants are adults ≥18 years). Multiple subject information sheets and informed consent forms are provided, including country-specific and language-specific ICFs (main ICF, pregnant partner ICF, pregnant subject ICF, optional genetic testing ICF, optional FSR ICF). Consent materials are available in local languages for participating Member States; no assent for minors is indicated. Contact for sponsor/public queries listed (SUMMIT Study Team: plozasiran@arrowheadpharma.com).
Methods
- Digital Waiting Room Ads — digital advertisements placed in clinic/hospital 'waiting room' digital displays (documented as 'Digital Waiting Room Ad' materials).
- Study Hub / Decentralized Clinical Trials Study Hub — online/mobile Study Hub for participant setup and engagement; 'Study Hub Mobile View' and 'Setup Patient Instructions' referenced in recruitment materials.
- Doctor-to-Patient letters / site referral — 'Doctor to Patient Letter' materials for clinicians to refer potentially eligible patients.
- Patient brochures, posters and ID cards — printed materials for patients at sites ('Patient Brochure', 'Patient Poster', 'Patient ID card').
- Pre-screening website and ePR participant journey emails — online pre-screening content and participant journey email communications ('Patient Pre-screening Website Content', 'ePR Participant Journey Emails').
- Referral Hub and outreach — referral hub materials and outreach/advertising documents (country-specific supporting documents listed).
- Country-specific recruitment packs — multiple Member State-specific recruiter materials and translations (e.g., BG, HR, PL, SK, HU, CZ, IT, ES, BE).
Geography
- Total Number Of Sites
- 89
- Total Number Of Participants
- 276
Romania
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 18-08-2025
- Processing Time Days
- 354
- Number Of Sites
- 9
- Number Of Participants
- 9
Sites
- Site Name
- Diamed Obesity S.R.L.
- Department Name
- Medicina Interna
- Principal Investigator Name
- Magdalena Morosanu
- Principal Investigator Email
- magda_m28@yahoo.com
- Contact Person Name
- Magdalena Morosanu
- Contact Person Email
- magda_m28@yahoo.com
- Site Name
- CMI Dr. Busegeanu Mihaela Magdalena
- Department Name
- Medicina Interna
- Principal Investigator Name
- Mihaela-Magdalena Busegeanu
- Principal Investigator Email
- mi_busegeanu@yahoo.com
- Contact Person Name
- Mihaela-Magdalena Busegeanu
- Contact Person Email
- mi_busegeanu@yahoo.com
- Site Name
- Spitalul Judetean De Urgenta Deva
- Department Name
- Medicina Interna
- Principal Investigator Name
- Rodica-Ioana Avram
- Principal Investigator Email
- rodamail@gmail.com
- Contact Person Name
- Rodica-Ioana Avram
- Contact Person Email
- rodamail@gmail.com
- Site Name
- Centrul Medical Unirea S.R.L.
- Department Name
- Cardiologie
- Principal Investigator Name
- Codrut Ioan Ciurea
- Principal Investigator Email
- codrut_ciurea@yahoo.com
- Contact Person Name
- Codrut Ioan Ciurea
- Contact Person Email
- codrut_ciurea@yahoo.com
- Site Name
- Angiocare S.R.L.
- Department Name
- Cardiologie Interventionala
- Principal Investigator Name
- Stefan Dan Cezar Mot
- Principal Investigator Email
- aresmonzacluj@gmail.com
- Contact Person Name
- Stefan Dan Cezar Mot
- Contact Person Email
- aresmonzacluj@gmail.com
- Site Name
- Medicali's S.R.L.
- Department Name
- Medicina Interna/ Cardiologie
- Principal Investigator Name
- Gabriela Valentina Ciobotaru
- Principal Investigator Email
- medicaliss@gmail.com
- Contact Person Name
- Gabriela Valentina Ciobotaru
- Contact Person Email
- medicaliss@gmail.com
- Site Name
- Diana Barbonta S.R.L.
- Department Name
- Diabet, Nutritie, Boli Metabolice
- Principal Investigator Name
- Diana-Hortensia Barbonta
- Principal Investigator Email
- db@dianabarbonta.eu
- Contact Person Name
- Diana-Hortensia Barbonta
- Contact Person Email
- db@dianabarbonta.eu
- Site Name
- Clinica Medicala Data Plus S.R.L.
- Department Name
- Medicina Interna
- Principal Investigator Name
- Iulian Copaci
- Principal Investigator Email
- iulian_copaci@yahoo.com
- Contact Person Name
- Iulian Copaci
- Contact Person Email
- iulian_copaci@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Targu Mures
- Department Name
- Cardiologie; Medicina Interna;
- Principal Investigator Name
- Theodora Benedek
- Principal Investigator Email
- theodora.benedek@umfst.ro
- Contact Person Name
- Theodora Benedek
- Contact Person Email
- theodora.benedek@umfst.ro
Spain
- Earliest CTIS Part Ii Submission Date
- 07-08-2024
- Latest Decision Or Authorization Date
- 13-08-2025
- Processing Time Days
- 371
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Endocrinología
- Principal Investigator Name
- Clara Bonanad
- Principal Investigator Email
- clarabonanad@gmail.com
- Contact Person Name
- Clara Bonanad
- Contact Person Email
- clarabonanad@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Endocrinología
- Principal Investigator Name
- Angel Michel Ortiz
- Principal Investigator Email
- angelmichael.ortiz@vallhebron.cat
- Contact Person Name
- Angel Michel Ortiz
- Contact Person Email
- angelmichael.ortiz@vallhebron.cat
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Endocrinología
- Principal Investigator Name
- Fernando Cereto
- Principal Investigator Email
- fernando.cereto@quironsalud.es
- Contact Person Name
- Fernando Cereto
- Contact Person Email
- fernando.cereto@quironsalud.es
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Endocrinología
- Principal Investigator Name
- Estíbaliz Jarauta
- Principal Investigator Email
- informacion.sector2@salud.aragon.es
- Contact Person Name
- Estíbaliz Jarauta
- Contact Person Email
- informacion.sector2@salud.aragon.es
Italy
- Earliest CTIS Part Ii Submission Date
- 18-06-2024
- Latest Decision Or Authorization Date
- 13-08-2025
- Processing Time Days
- 421
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Endocrinology, Diabetology and Andrology
- 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
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Dyslipidemia
- Principal Investigator Name
- Giuliana Germana Mombelli
- Principal Investigator Email
- giuliana.mombelli@ospedaleniguarda.it
- Contact Person Name
- Giuliana Germana Mombelli
- Contact Person Email
- giuliana.mombelli@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- 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
- 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
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Center for Endocrine and Metabolic Diseases
- Principal Investigator Name
- Andrea Giaccari
- Principal Investigator Email
- andrea.giaccari@unicatt.it
- Contact Person Name
- Andrea Giaccari
- Contact Person Email
- andrea.giaccari@unicatt.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Cardiology
- Principal Investigator Name
- Savina Nodari
- Principal Investigator Email
- savina.nodari@unibs.it
- Contact Person Name
- Savina Nodari
- Contact Person Email
- savina.nodari@unibs.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto (additional listed site)
- Department Name
- Medical and Surgical Sciences Department
Czechia
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 13-08-2025
- Processing Time Days
- 348
- Number Of Sites
- 11
- Number Of Participants
- 18
Sites
- 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
- 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
- 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
- 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
- Kardiologie Vinohrady s.r.o.
- Principal Investigator Name
- Vladimir Hrabos
- Principal Investigator Email
- vlahra@yahoo.com
- Contact Person Name
- Vladimir Hrabos
- Contact Person Email
- vlahra@yahoo.com
- 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
- Fakultni Thomayerova nemocnice
- Department Name
- Klinicko-farmakologicka jednotka
- Principal Investigator Name
- Jiri Skopek
- Principal Investigator Email
- jiri.skopek1@ftn.cz
- Contact Person Name
- Jiri Skopek
- Contact Person Email
- jiri.skopek1@ftn.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
- Fakultni Thomayerova nemocnice (additional listed site)
- 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
- 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
- Site Name
- Medical Plus / other listed site
Croatia
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 13-08-2025
- Processing Time Days
- 348
- Number Of Sites
- 7
- Number Of Participants
- 12
Sites
- Site Name
- Clinical Hospital Dubrava
- Department Name
- Cardiology
- Principal Investigator Name
- Nikola Pavlović
- Principal Investigator Email
- nikolap12@yahoo.com
- Contact Person Name
- Nikola Pavlović
- Contact Person Email
- nikolap12@yahoo.com
- Site Name
- Opca Bolnica Zadar
- Department Name
- Cardiology
- Principal Investigator Name
- Zoran Bakotić
- Principal Investigator Email
- zbakotic@gmail.com
- Contact Person Name
- Zoran Bakotić
- Contact Person Email
- zbakotic@gmail.com
- Site Name
- Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
- Department Name
- Resuscitation and intensive care
- Principal Investigator Name
- Krunoslav Fučkar
- Principal Investigator Email
- krunoslavf93@gmail.com
- Contact Person Name
- Krunoslav Fučkar
- Contact Person Email
- krunoslavf93@gmail.com
- Site Name
- Opca Bolnica Karlovac
- Department Name
- Endocrinology
- Principal Investigator Name
- Ivana Šunić Grčić
- Principal Investigator Email
- ivanasunic@yahoo.com
- Contact Person Name
- Ivana Šunić Grčić
- Contact Person Email
- ivanasunic@yahoo.com
- Site Name
- University Hospital Centre Zagreb
- Department Name
- Internal Medicine
- Principal Investigator Name
- Željko Reiner
- Principal Investigator Email
- zreiner@kbc-zagreb.hr
- Contact Person Name
- Željko Reiner
- Contact Person Email
- zreiner@kbc-zagreb.hr
- Site Name
- Poliklinika Solmed d.o.o.
- Department Name
- Endocrinology
- Principal Investigator Name
- Ivan Kruljac
- Principal Investigator Email
- ivan.kruljac@solmed-clinic.com
- Contact Person Name
- Ivan Kruljac
- Contact Person Email
- ivan.kruljac@solmed-clinic.com
- Site Name
- Opca Bolnica (additional listed site)
- Department Name
- Endocrinology
Poland
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 18-08-2025
- Processing Time Days
- 353
- Number Of Sites
- 12
- Number Of Participants
- 28
Sites
- Site Name
- Futuremeds Sp. z o.o. (Wroclaw)
- Department Name
- FutureMeds Wroclaw - site
- Principal Investigator Name
- Paulina Ludziak-Tomiałowicz
- Principal Investigator Email
- paulina.ludziak@futuremeds.com
- Contact Person Name
- Paulina Ludziak-Tomiałowicz
- Contact Person Email
- paulina.ludziak@futuremeds.com
- Site Name
- Futuremeds Sp. z o.o. (Warsaw)
- Department Name
- FutureMeds Warszawa Centrum - site
- Principal Investigator Name
- Magda Fliszkiewicz
- Principal Investigator Email
- magda.fliszkiewicz@futuremeds.com
- Contact Person Name
- Magda Fliszkiewicz
- Contact Person Email
- magda.fliszkiewicz@futuremeds.com
- Site Name
- Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
- Department Name
- NZOZ Centrum Medyczne KERmed - site
- Principal Investigator Name
- Tomasz Ługowski
- Principal Investigator Email
- tomasz.lugowski@kermed.pl
- Contact Person Name
- Tomasz Ługowski
- Contact Person Email
- tomasz.lugowski@kermed.pl
- Site Name
- Sedimed Sp. z o.o.
- Department Name
- CM Sedimed - site
- Principal Investigator Name
- Anna Bienkiewicz
- Principal Investigator Email
- biuro@sedimed.pl
- Contact Person Name
- Anna Bienkiewicz
- Contact Person Email
- biuro@sedimed.pl
- Site Name
- Futuremeds Sp. z o.o. (Lodz)
- Department Name
- FutureMeds Łódź - site
- Principal Investigator Name
- Katarzyna Bartnicka-Masłowska
- Principal Investigator Email
- katarzyna.bartnicka@amed.med.pl
- Contact Person Name
- Katarzyna Bartnicka-Masłowska
- Contact Person Email
- katarzyna.bartnicka@amed.med.pl
- Site Name
- Pratia S.A.
- Department Name
- Pratia MCM Krakow - site
- 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 Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
- Principal Investigator Name
- Bożena Górnikiewicz-Brzezicka
- Principal Investigator Email
- b.gornikiewicz-brzezicka@ckb.elblag.pl
- Contact Person Name
- Bożena Górnikiewicz-Brzezicka
- Contact Person Email
- b.gornikiewicz-brzezicka@ckb.elblag.pl
- Site Name
- Niepubliczny Zakład Opieki Zdrowotnej "terapia Optima"
- Principal Investigator Name
- Bogusłąw Okopień
- Principal Investigator Email
- farmakopea@rubikon.pl
- Contact Person Name
- Bogusłąw Okopień
- Contact Person Email
- farmakopea@rubikon.pl
- Site Name
- Krakowskie Centrum Medyczne Sp. z o.o.
- Department Name
- Krakowskie Centrum Medyczne - site
- 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
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Odział Kliniczny Chorób Serca i Naczyń z Pododdziałem nadzoru Kardiologicznego
- Principal Investigator Name
- Monika Komar
- Principal Investigator Email
- moni_s@interia.pl
- Contact Person Name
- Monika Komar
- Contact Person Email
- moni_s@interia.pl
- 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
- Futuremeds Sp. z o.o. (Warsaw - Targówek)
- Department Name
- FutureMeds Targówek - site
- Principal Investigator Name
- Agnieszka Jurek-Urbanowska
- Principal Investigator Email
- agnieszka.urbanowska@futuremeds.com
- Contact Person Name
- Agnieszka Jurek-Urbanowska
- Contact Person Email
- agnieszka.urbanowska@futuremeds.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 26-08-2024
- Latest Decision Or Authorization Date
- 12-08-2025
- Processing Time Days
- 351
- Number Of Sites
- 6
- Number Of Participants
- 19
Sites
- Site Name
- Dr. Luc Capiau
- Department Name
- General practicioner
- Principal Investigator Name
- Luc Capiau
- Principal Investigator Email
- luc.capiau@telenet.be
- Contact Person Name
- Luc Capiau
- Contact Person Email
- luc.capiau@telenet.be
- Site Name
- Pneumocare
- Department Name
- cardiology
- Principal Investigator Name
- Laurent Jamart
- Principal Investigator Email
- laurent.jamart@chrsm.be
- Contact Person Name
- Laurent Jamart
- Contact Person Email
- laurent.jamart@chrsm.be
- Site Name
- Medif
- Department Name
- General practicioner
- Principal Investigator Name
- Marc De Meulemeester
- Principal Investigator Email
- demeu@brutele.be
- Contact Person Name
- Marc De Meulemeester
- Contact Person Email
- demeu@brutele.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- cardiology
- Principal Investigator Name
- Karl Dujardin
- Principal Investigator Email
- karl.dujardin@azdelta.be
- Contact Person Name
- Karl Dujardin
- Contact Person Email
- karl.dujardin@azdelta.be
- Site Name
- A.Z. Sint-Maarten
- Department Name
- Cardiology
- Principal Investigator Name
- Geert Vervoort
- Principal Investigator Email
- geert.vervoort@emmaus.be
- Contact Person Name
- Geert Vervoort
- Contact Person Email
- geert.vervoort@emmaus.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- cardiology
- Principal Investigator Name
- Pieter Koopman
- Principal Investigator Email
- pieter.koopman@jessazh.be
- Contact Person Name
- Pieter Koopman
- Contact Person Email
- pieter.koopman@jessazh.be
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
- 9
- Number Of Participants
- 14
Sites
- 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
- Medi M&M s.r.o.
- Department Name
- Kardiologicka ambulancia
- Principal Investigator Name
- Michal Banik
- Principal Investigator Email
- medi.banik@gmail.com
- Contact Person Name
- Michal Banik
- Contact Person Email
- medi.banik@gmail.com
- Site Name
- Medical group Kosice s.r.o.
- Department Name
- Kardiologicka ambulancia
- Principal Investigator Name
- Ivan Majercak
- Principal Investigator Email
- majercak@medicalgroup.sk
- Contact Person Name
- Ivan Majercak
- Contact Person Email
- majercak@medicalgroup.sk
- 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
- Site Name
- Fakultna Nemocnica Nitra
- Department Name
- Angiologicka ambulancia
- Principal Investigator Name
- Peter Minarik
- Principal Investigator Email
- peterminarik@atlas.sk
- Contact Person Name
- Peter Minarik
- Contact Person Email
- peterminarik@atlas.sk
- Site Name
- Cardio D&R s.r.o. Kosice
- Department Name
- Kardiologicka ambulancia
- Principal Investigator Name
- Jan Fedacko
- Principal Investigator Email
- janfedacko@hotmail.com
- Contact Person Name
- Jan Fedacko
- Contact Person Email
- janfedacko@hotmail.com
- Site Name
- MUDr. Viliam Cibik PhD. s.r.o.
- Department Name
- Vseobecna ambulancia
- Principal Investigator Name
- Viliam Cibik
- Principal Investigator Email
- viliam.cibik@gmail.com
- Contact Person Name
- Viliam Cibik
- Contact Person Email
- viliam.cibik@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
- 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
Hungary
- Earliest CTIS Part Ii Submission Date
- 26-07-2024
- Latest Decision Or Authorization Date
- 14-08-2025
- Processing Time Days
- 384
- Number Of Sites
- 7
- Number Of Participants
- 15
Sites
- Site Name
- Belvaros-Lipotvaros Egeszseguegyi Szolgalat
- Department Name
- Belgyógyászat-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
- Uno Medical Trials Kft.
- Principal Investigator Name
- Nikosz Kanakaridisz
- Principal Investigator Email
- kanakaridisznikosz@unomedicaltrials.hu
- Contact Person Name
- Nikosz Kanakaridisz
- Contact Person Email
- kanakaridisznikosz@unomedicaltrials.hu
- Site Name
- Clinexpert Kft.
- Principal Investigator Name
- Tamás Bárány
- Principal Investigator Email
- drbaranytamas@gmail.com
- Contact Person Name
- Tamás Bárány
- Contact Person Email
- drbaranytamas@gmail.com
- Site Name
- University Of Szeged (Szeged)
- Department Name
- 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
- Minoseg Orvoscsoport Kft.
- 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
- Privat Doktor Egeszseguegyi Szolgaltato Zrt.
- 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
- University Of Szeged (additional listed site)
- Department Name
- Belgyogyaszati Klinika Nyugati telephely
- Principal Investigator Name
- Takács Róbert
- Principal Investigator Email
- takacs.robert@med.u-szeged.hu
- Contact Person Name
- Takács Róbert
- Contact Person Email
- takacs.robert@med.u-szeged.hu
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 627
- Number Of Sites
- 17
- Number Of Participants
- 35
Sites
- Site Name
- Medical Center Prolet EOOD
- Principal Investigator Name
- Penka Kamenova
- Principal Investigator Email
- dr.penka.kamenova@gmail.com
- Contact Person Name
- Penka Kamenova
- Contact Person Email
- dr.penka.kamenova@gmail.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 Medicabilis Ltd.
- Principal Investigator Name
- Sarkis Kalustian
- Principal Investigator Email
- d_rkalustian@abv.bg
- Contact Person Name
- Sarkis Kalustian
- Contact Person Email
- d_rkalustian@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
- Multi-profile Hospital for Active Treatment Heart and Brain EAD
- Department Name
- Clinic of cardiology
- Principal Investigator Name
- Evelina Asenova
- Principal Investigator Email
- e.asenova@heartandbrain.bg
- Contact Person Name
- Evelina Asenova
- Contact Person Email
- e.asenova@heartandbrain.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
- 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
- Medical Center Rodopimed EOOD
- Principal Investigator Name
- Kyamuran Mestan
- Principal Investigator Email
- kyamuranmestan@gmail.com
- Contact Person Name
- Kyamuran Mestan
- Contact Person Email
- kyamuranmestan@gmail.com
- 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
- 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
- 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
- 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
- Ambulatory of specialized outpatient medical help in internal diseases and cardiology Individual practice Cardio Tonus EOOD
- Principal Investigator Name
- Ivaylo Ivanov
- Principal Investigator Email
- ivaylo_p_ivanov@abv.bg
- Contact Person Name
- Ivaylo Ivanov
- Contact Person Email
- ivaylo_p_ivanov@abv.bg
- 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 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 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
- Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD (additional)
- 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
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
- Clinical trial operations and multiple study support functions (sponsorDuties codes: 1,10,11,12,13,2,5,6,8)
- Name
- Medidata Solutions Inc.
- Responsibilities
- Electronic data capture/eClinical services (sponsorDuties code: 7)
- Name
- Suvoda LLC
- Responsibilities
- Clinical trial technology / eClinical (sponsorDuties code: 3)
- Name
- Medpace Reference Laboratories LLC / MEDPACE LABORATORIES
- Responsibilities
- Biomarker and laboratory analyses (sponsorDuties codes: 15 and 4)
Third parties
- {"country":"Canada","full_name":"The University Of Western Ontario","duties_or_roles":"Genetic testing","organisation_type":"Educational Institution"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,2,5,6,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Keystone Bioanalytical Inc.","duties_or_roles":"PK testing (code 15)","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":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"Antibody testing (code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Manufacturing Packaging Farmaca (MPF) B.V.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement (code 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Sharp Corp.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
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 GalNAc ligand (three N-acetylgalactosamine residues)
- Modality
- Oligonucleotide
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Not authorised in the population involved (investigational in this trial)
- Orphan Designation
- Yes
- Maximum Dose
- 100 mg (max total dose amount), max daily dose 25 mg
- Investigational Product Name
- Plozasiran Injection Placebo
- Active Substance
- N/A (placebo)
- Modality
- Other
- Authorisation Status
- Placebo (not applicable)
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