Clinical trial • Phase III • Cardiology

LAROPROVSTAT for Heterozygous familial hypercholesterolemia

Phase III trial of LAROPROVSTAT for Heterozygous familial hypercholesterolemia.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Heterozygous familial hypercholesterolemia
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
25-04-2025
First CTIS Authorization Date
18-08-2025

Trial design

Randomised, azd0780 placebo (matching placebo) - dose/schedule not specified in the provided record-controlled Phase III trial in Czechia, Norway, Netherlands and others.

Randomised
Yes
Comparator
AZD0780 Placebo (matching placebo) - dose/schedule not specified in the provided record
Target Sample Size
253
Trial Duration For Participant
364

Eligibility

Recruits 253 adults.

Inclusion criteria

  • {"criterion_text":"- ≥ 18 years of age at the time of signing the ICF.\n- Diagnosis of HeFH by genetic confirmation or a definite clinical diagnosis, ie, a score > x using the Dutch Lipid Network [Nordestgaard et al 2013] or equivalent as per internationally accepted diagnostic algorithms (AHA [Gidding et al 2015], US MEDPED [Williams et al 1993], Simon Broome [Scientific Steering Committee on behalf of the Simon Broome Register Group 1991], or Japanese Atherosclerosis Society Guidelines [Okamura et al 2024])\n- Fasting serum by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with HeFH and clinical ASCVD or ≥ 70 mg/dL (≥ 1.8 mmol/L) in HeFH without clinical ASCVD. Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease.\n- Participants should receive a background lipid lowering regimen anticipated to achieve at least a ~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high-intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid). Thus, the background lipid-lowering therapy must consist of one of the following: − A high-intensity LDL lowering regimen (i) A high intensity statin regimen, as defined by country specific guidelines Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended OR: (ii) A lower intensity statin regimen in combination with ezetimibe and/or bempedoic acid OR: − A maximum tolerated statin regimen - Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended. Participants must achieve a stable background lipid-lowering therapy > 28 days before screening."}

Exclusion criteria

  • {"criterion_text":"- Homozygous familial hypercholesterolaemia, LDL apheresis or plasma apheresis within 12 months prior to screening, or any other underlying known disease or condition that may interfere with interpretation of the clinical study results as judged by the Investigator\n- Any of the following laboratory values at screening: - Calculated eGFR < 15 mL/min/1.73 m2 (CKD-EPI formula; Delgado et al 2022, Inker et al 2021) - AST or ALT > 3 × ULN - TBL > 2 × ULN (except for patients with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin < 1.5 × ULN) - Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L) - Creatine Kinase > 5X ULN - Urine albumin to creatinine ratio ≥ 500mg/g\n- Uncontrolled type 2 diabetes mellitus defined as HbA1c ≥ 9.5% at screening\n- Inadequately treated hypothyroidism defined as TSH > 1.5 ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening\n- Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months prior to screening or planned use during the study\n- Use of gemfibrozil within 1 week prior to screening or planned use during the study\n- Use of PCSK-9 inhibitors: evolocumab/alirocumab within 12 weeks of the screening visit or planned use during the study or inclisiran within 18 months of the screening visit or planned use during the study. Any other approved PCSK-9 inhibitor use within 5 half lives prior to the screening visit or planned use during the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Relative change in LDL-C from baseline to 12 weeks","definition_or_measurement_approach":"Relative change in LDL-C from baseline to 12 weeks"}

Secondary endpoints

  • {"endpoint_text":"- Relative change in LDL-C from baseline to 12 weeks (in patients on background statin therapy at baseline)","definition_or_measurement_approach":"Relative change in LDL-C from baseline to 12 weeks (in patients on background statin therapy at baseline)"}
  • {"endpoint_text":"- Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks","definition_or_measurement_approach":"Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks"}
  • {"endpoint_text":"- Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks","definition_or_measurement_approach":"Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks"}
  • {"endpoint_text":"- Relative change in LDL-C from baseline to 28 weeks","definition_or_measurement_approach":"Relative change in LDL-C from baseline to 28 weeks"}
  • {"endpoint_text":"- Relative change in LDL-C from baseline to 52 weeks","definition_or_measurement_approach":"Relative change in LDL-C from baseline to 52 weeks"}
  • {"endpoint_text":"- Relative change in Apo B from baseline to 12 weeks","definition_or_measurement_approach":"Relative change in Apo B from baseline to 12 weeks"}
  • {"endpoint_text":"- Relative change in non-HDL-C from baseline to 12 weeks","definition_or_measurement_approach":"Relative change in non-HDL-C from baseline to 12 weeks"}
  • {"endpoint_text":"- Relative change in total cholesterol from baseline to 12 weeks","definition_or_measurement_approach":"Relative change in total cholesterol from baseline to 12 weeks"}
  • {"endpoint_text":"- Relative change in Lp(a) from baseline to 12 weeks","definition_or_measurement_approach":"Relative change in Lp(a) from baseline to 12 weeks"}

Recruitment

Planned Sample Size
253
Recruitment Window Months
21
Consent Approach
Informed consent is required from participants aged ≥ 18 years (inclusion criterion: ≥ 18 years of age). Subject information and informed consent form documents (L1_SIS and ICF Adult and country-specific ICFs) are listed in the trial documents, but the available data do not include the consent/assent text or explicit language availability or age-specific assent procedures.

Geography

Total Number Of Sites
72
Total Number Of Participants
152

Czechia

Earliest CTIS Part Ii Submission Date
05-08-2025
Latest Decision Or Authorization Date
27-11-2025
Processing Time Days
114
Number Of Sites
9
Number Of Participants
9

Sites

Site Name
Endokrinologie Cerny Most s.r.o.
Department Name
endokrinologie a diabetologie
Principal Investigator Name
Lukas Zlatohlavek
Principal Investigator Email
lukas.zlatohlavek@gmail.com
Contact Person Name
Lukas Zlatohlavek
Contact Person Email
lukas.zlatohlavek@gmail.com
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
III interni gerontometabolicka klinika
Principal Investigator Name
Vladimir Blaha
Principal Investigator Email
vladimir.blaha@lfhk.cuni.cz
Contact Person Name
Vladimir Blaha
Contact Person Email
vladimir.blaha@lfhk.cuni.cz
Site Name
KardioBusak s.r.o.
Principal Investigator Name
Ladislav Busak
Principal Investigator Email
L.Busak@seznam.cz
Contact Person Name
Ladislav Busak
Contact Person Email
L.Busak@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
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 U Sv Anny V Brne
Department Name
Oddělení klinické biochemie
Principal Investigator Name
Ondrej Kyselak
Principal Investigator Email
ondrej.kyselak@fnusa.cz
Contact Person Name
Ondrej Kyselak
Contact Person Email
ondrej.kyselak@fnusa.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
III.interni klinika. Klinika endokrinologie a metabolismu
Principal Investigator Name
Richard Ceska
Principal Investigator Email
richard.ceska@vfn.cz
Contact Person Name
Richard Ceska
Contact Person Email
richard.ceska@vfn.cz
Site Name
MUDr. Nina Zemkova s.r.o.
Department Name
Interní a diabetologická ambulance
Principal Investigator Name
Stanislav Zemek
Principal Investigator Email
zemeks@post.cz
Contact Person Name
Stanislav Zemek
Contact Person Email
zemeks@post.cz
Site Name
Clinoxus s.r.o.
Principal Investigator Name
Jaroslav Macasek
Principal Investigator Email
jmacasek@seznam.cz
Contact Person Name
Jaroslav Macasek
Contact Person Email
jmacasek@seznam.cz

Norway

Earliest CTIS Part Ii Submission Date
16-07-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
133
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
St. Olavs Hospital HF
Department Name
St. Olavs Hospital HF
Principal Investigator Name
Elisabeth Kleivhaug Vesterbekkmo
Principal Investigator Email
lisabeth.k.vesterbekkmo@stolav.no
Contact Person Name
Elisabeth Kleivhaug Vesterbekkmo
Site Name
Sykehuset Ostfold HF
Department Name
Cardiological Department
Principal Investigator Name
Svein Vibjar Romsvik
Principal Investigator Email
sverom@so-hf.no
Contact Person Name
Svein Vibjar Romsvik
Contact Person Email
sverom@so-hf.no
Site Name
Oslo University Hospital HF
Department Name
Lipid Clinic
Principal Investigator Name
Emil Asprusten
Principal Investigator Email
b22400@ous-hf.no
Contact Person Name
Emil Asprusten
Contact Person Email
b22400@ous-hf.no
Site Name
Nordlandssykehuset HF
Department Name
Nordlandssykehuset HF
Principal Investigator Name
Knut Tore Lappegård
Principal Investigator Email
knut.tore.lappegard@gmail.com
Contact Person Name
Knut Tore Lappegård
Contact Person Email
knut.tore.lappegard@gmail.com
Site Name
Colosseumklinikken Medisinske Senter AS
Department Name
Colosseumklinikken
Principal Investigator Name
Lars Kristian Gullestad
Principal Investigator Email
larsgullestad@gmail.com
Contact Person Name
Lars Kristian Gullestad
Contact Person Email
larsgullestad@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
116
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
Vascular Medicine
Principal Investigator Name
Frank Visseren
Principal Investigator Email
F.L.J.Visseren@umcutrecht.nl
Contact Person Name
Frank Visseren
Contact Person Email
F.L.J.Visseren@umcutrecht.nl
Site Name
Academisch Medisch Centrum
Department Name
Vascular Medicine
Principal Investigator Name
Erik Stroes
Principal Investigator Email
E.S.Stroes@amsterdamumc.nl
Contact Person Name
Erik Stroes
Contact Person Email
E.S.Stroes@amsterdamumc.nl
Site Name
Bravis Ziekenhuis
Department Name
Internal Medicine
Principal Investigator Name
Mustafa Ezzahti
Principal Investigator Email
m.ezzahti@bravis.nl
Contact Person Name
Mustafa Ezzahti
Contact Person Email
m.ezzahti@bravis.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Internal Medicine
Principal Investigator Name
Jeanine Roeters van Lennep
Principal Investigator Email
J.RoetersvanLennep@erasmusmc.nl
Contact Person Name
Jeanine Roeters van Lennep

France

Earliest CTIS Part Ii Submission Date
17-07-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
132
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Hospices Civils De Lyon
Department Name
Service d’endocrinologie, diabétologie, Maladies Métaboliques et Nutrition
Principal Investigator Name
Sybil CHARRIERE
Principal Investigator Email
sybil.charriere@chu-lyon.fr
Contact Person Name
Sybil CHARRIERE
Contact Person Email
sybil.charriere@chu-lyon.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Service de nutrition
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 Universitaire De Dijon
Department Name
Service d'Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition
Principal Investigator Name
Bruno VERGES
Principal Investigator Email
bruno.verges@chu-dijon.fr
Contact Person Name
Bruno VERGES
Contact Person Email
bruno.verges@chu-dijon.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service d'endocrinologie, maladies métaboliques et Nutrition
Principal Investigator Name
Sophie BELIARD
Principal Investigator Email
sophie.beliard@ap-hm.fr
Contact Person Name
Sophie BELIARD
Contact Person Email
sophie.beliard@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Département d'Endocrinologie, Diabétologie et Nutrition
Principal Investigator Name
Bertrand CARIOU
Principal Investigator Email
bertrand.cariou@univ-nantes.fr
Contact Person Name
Bertrand CARIOU
Contact Person Email
bertrand.cariou@univ-nantes.fr

Bulgaria

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
116
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Principal Investigator Name
Blagovest Stoimenov
Principal Investigator Email
stoimenov90@gmail.com
Contact Person Name
Blagovest Stoimenov
Contact Person Email
stoimenov90@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of cardiology
Principal Investigator Name
Fedya Nikolov
Principal Investigator Email
prof.fedya.nikolov@gmail.com
Contact Person Name
Fedya Nikolov
Contact Person Email
prof.fedya.nikolov@gmail.com
Site Name
Diagnostic-Consultative Center Alexandrovska EOOD
Principal Investigator Name
Raya Ivanova
Principal Investigator Email
raiavanova@abv.bg
Contact Person Name
Raya Ivanova
Contact Person Email
raiavanova@abv.bg
Site Name
Medical Center Isul Tsaritsa Yoanna EOOD
Principal Investigator Name
Angelina Borizanova-Petkova
Principal Investigator Email
borizanowa@abv.bg
Contact Person Name
Angelina Borizanova-Petkova
Contact Person Email
borizanowa@abv.bg
Site Name
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
Department Name
First clinic of cardiology
Principal Investigator Name
Petar Polomski
Principal Investigator Email
ppolomski@gmail.com
Contact Person Name
Petar Polomski
Contact Person Email
ppolomski@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
23-07-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
126
Number Of Sites
7
Number Of Participants
19

Sites

Site Name
Region Midtjylland
Department Name
Department of Cardiology
Principal Investigator Name
Erik Lerkevang Grove
Principal Investigator Email
erikgrov@rm.dk
Contact Person Name
Erik Lerkevang Grove
Contact Person Email
erikgrov@rm.dk
Site Name
Region Midtjylland
Department Name
Department of Cardiac Reserach
Principal Investigator Name
Morten Böttcher
Principal Investigator Email
morboett@rm.dk
Contact Person Name
Morten Böttcher
Contact Person Email
morboett@rm.dk
Site Name
Region Hovedstaden
Department Name
Department of Cardiology
Principal Investigator Name
Merete Heitmann
Principal Investigator Email
merete.heitmann@regionh.dk
Contact Person Name
Merete Heitmann
Contact Person Email
merete.heitmann@regionh.dk
Site Name
Region Hovedstaden
Department Name
Department of Cardiology
Principal Investigator Name
Jens Dahlgaard Hove
Principal Investigator Email
Jens.dahlgaard.hove@regionh.dk
Contact Person Name
Jens Dahlgaard Hove
Contact Person Email
Jens.dahlgaard.hove@regionh.dk
Site Name
Esbjerg Og Grindsted Sygehus
Department Name
Cardiovascular Reserach Department
Principal Investigator Name
Kristian Korsgaard Thomsen
Principal Investigator Email
kristian.korsgaard.thomsen@rsyd.dk
Contact Person Name
Kristian Korsgaard Thomsen
Site Name
Region Midtjylland
Department Name
Department of Cardiology
Principal Investigator Name
Malene Hollingdal
Principal Investigator Email
Malene.hollingdal@midt.rm.dk
Contact Person Name
Malene Hollingdal
Contact Person Email
Malene.hollingdal@midt.rm.dk
Site Name
Region Hovedstaden
Department Name
Department of Cardiology
Principal Investigator Name
Gunnar Gislason
Principal Investigator Email
Gunnar.gislason@regionh.dk
Contact Person Name
Gunnar Gislason
Contact Person Email
Gunnar.gislason@regionh.dk

Sweden

Earliest CTIS Part Ii Submission Date
14-05-2025
Latest Decision Or Authorization Date
27-11-2025
Processing Time Days
197
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Verksamhetsområde HjärtLungmedicin, Remissgatan 4, Skåne University Hospital, 22242 Lund
Principal Investigator Name
David Erlinge
Principal Investigator Email
david.erlinge@gmail.com
Contact Person Name
David Erlinge
Contact Person Email
david.erlinge@gmail.com
Site Name
Region Vaestmanland
Department Name
Department of Cardiology, Västerås Hospital
Principal Investigator Name
Andree Farahani
Principal Investigator Email
Andree.farahani@regionvastmanland.se
Contact Person Name
Andree Farahani
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Sahlgrenska University Hospital, VO Kardiologi, Blå Stråket 3, 413 46 Gothenburg
Principal Investigator Name
Stefano Romeo
Principal Investigator Email
stefano.romeo@wlab.gu.se
Contact Person Name
Stefano Romeo
Contact Person Email
stefano.romeo@wlab.gu.se
Site Name
Region Oestergoetland
Department Name
Department of Cardiology, Heart Center, 581 85 Linköping, Universitetssjukhuset i Linköping
Principal Investigator Name
Ted Cabreira
Principal Investigator Email
ted.cabreira@regionostergotland.se
Contact Person Name
Ted Cabreira
Site Name
Karolinska University Hospital
Department Name
ME Endokrinologi, Hälsovägen 13, 141 86 Stockholm
Principal Investigator Name
Daniel Eriksson Hogling
Principal Investigator Email
daniel.eriksson-hogling@regionstockholm.se
Contact Person Name
Daniel Eriksson Hogling
Site Name
Akardo AB
Department Name
Akardo MedSite AB
Principal Investigator Name
Åke Olsson
Principal Investigator Email
ake.olsson@akardomedsite.se
Contact Person Name
Åke Olsson
Contact Person Email
ake.olsson@akardomedsite.se
Site Name
Uppsala University Hospital
Department Name
Hjärtintensivvårdsavdelning 50 G, Sjukhusvägen 751 85 Uppsala, Akademiska Sjukhuset, Uppsala
Principal Investigator Name
Emil Hagström
Principal Investigator Email
emil.hagstrom@ucr.uu.se
Contact Person Name
Emil Hagström
Contact Person Email
emil.hagstrom@ucr.uu.se

Finland

Earliest CTIS Part Ii Submission Date
17-07-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
131
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Tampere University Hospital
Department Name
Unit of endocrinology, department of endocrinology
Principal Investigator Name
Saara Metso
Principal Investigator Email
saara.metso@pirha.fi
Contact Person Name
Saara Metso
Contact Person Email
saara.metso@pirha.fi
Site Name
Kuopio University Hospital
Department Name
Department of Endocrinology and clinical nutrition
Principal Investigator Name
Reeta Rintamaki
Principal Investigator Email
reeta.rintamaki@pshyvinvointialue.fi
Contact Person Name
Reeta Rintamaki
Site Name
Turku University Hospital
Department Name
Heart Center
Principal Investigator Name
Tuomas Kiviniemi
Principal Investigator Email
tuoski@utu.fi
Contact Person Name
Tuomas Kiviniemi
Contact Person Email
tuoski@utu.fi
Site Name
HUS-Yhtymae
Department Name
Cardiology department
Principal Investigator Name
Markku Pentikainen
Principal Investigator Email
markku.pentikainen@hus.fi
Contact Person Name
Markku Pentikainen
Contact Person Email
markku.pentikainen@hus.fi

Slovakia

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
116
Number Of Sites
6
Number Of Participants
9

Sites

Site Name
Cardio D&R s.r.o. Kosice
Department Name
Outpatient Cardiology Care
Principal Investigator Name
Ján Fedačko
Principal Investigator Email
janfedacko@hotmail.com
Contact Person Name
Ján Fedačko
Contact Person Email
janfedacko@hotmail.com
Site Name
Medivasa s.r.o.
Department Name
Outpatient care for diabetology and metabolic disorders and nutrition
Principal Investigator Name
Ingrid Bugáňová
Principal Investigator Email
dia1@medivasa.sk
Contact Person Name
Ingrid Bugáňová
Contact Person Email
dia1@medivasa.sk
Site Name
Diabeda s.r.o.
Department Name
Outpatient Clinic for Diabetes and Metabolic and Nutrition Disorders
Principal Investigator Name
Branislav Vohnout
Principal Investigator Email
diabetologiaraca@gmail.com
Contact Person Name
Branislav Vohnout
Contact Person Email
diabetologiaraca@gmail.com
Site Name
InterStom s.r.o.
Department Name
Outpatient care for Internal Medicine
Principal Investigator Name
Ladislav Šabo
Principal Investigator Email
sabolaco@gmail.com
Contact Person Name
Ladislav Šabo
Contact Person Email
sabolaco@gmail.com
Site Name
Premedix
Department Name
Outpatient Cardiology Care
Principal Investigator Name
Allan Böhm
Principal Investigator Email
allan.bohm@premedix.org
Contact Person Name
Allan Böhm
Contact Person Email
allan.bohm@premedix.org
Site Name
Medical KG s.r.o.
Department Name
Outpatient Internal Medicine care
Principal Investigator Name
Katarína Gonová
Principal Investigator Email
kgonova@yahoo.com
Contact Person Name
Katarína Gonová
Contact Person Email
kgonova@yahoo.com

Germany

Earliest CTIS Part Ii Submission Date
30-07-2025
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
135
Number Of Sites
6
Number Of Participants
8

Sites

Site Name
Kardiologische Praxen im Spreebogen
Principal Investigator Name
Florian Krackhardt
Principal Investigator Email
Florian.Krackhardt@gmx.de
Contact Person Name
Florian Krackhardt
Contact Person Email
Florian.Krackhardt@gmx.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Kardiologie und internistische Intensivmedizin
Principal Investigator Name
Derk Frank
Principal Investigator Email
derk.frank@uksh.de
Contact Person Name
Derk Frank
Contact Person Email
derk.frank@uksh.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik für Kardiologie
Principal Investigator Name
Irina Müller-Kozarez
Contact Person Name
Irina Müller-Kozarez
Site Name
Medical Center - University Of Freiburg
Department Name
Universitäts-Herzzentrum - Klinik für Kardiologie und Angiologie
Principal Investigator Name
Lucas Georg Bacmeister
Principal Investigator Email
lucas.bacmeister@uniklinik-freiburg.de
Contact Person Name
Lucas Georg Bacmeister
Site Name
Kardiopraxis Schirmer
Principal Investigator Name
Stephan H. Schirmer
Principal Investigator Email
schirmer@kardiopraxis-schirmer.de
Contact Person Name
Stephan H. Schirmer
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik III, Lipidologie und Lipoproteinapherese
Principal Investigator Name
Ulrike Schatz
Principal Investigator Email
Ulrike.schatz@uniklinikum-dresden.de
Contact Person Name
Ulrike Schatz

Hungary

Earliest CTIS Part Ii Submission Date
08-08-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
115
Number Of Sites
9
Number Of Participants
17

Sites

Site Name
Ezustfeny Klinika Kft.
Principal Investigator Name
Tamás Frész
Principal Investigator Email
drfresztamas@yahoo.com
Contact Person Name
Tamás Frész
Contact Person Email
drfresztamas@yahoo.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
Medifarma-98 Kft.
Principal Investigator Name
Zsolt Zilahi
Principal Investigator Email
drzilahi@gmail.com
Contact Person Name
Zsolt Zilahi
Contact Person Email
drzilahi@gmail.com
Site Name
CRU Hungary Kft.
Principal Investigator Name
Melinda Nagyné Kovács
Principal Investigator Email
mkovacs@cruint.com
Contact Person Name
Melinda Nagyné Kovács
Contact Person Email
mkovacs@cruint.com
Site Name
University Of Debrecen
Principal Investigator Name
Dénes Páll
Principal Investigator Email
pall.denes@unideb.hu
Contact Person Name
Dénes Páll
Contact Person Email
pall.denes@unideb.hu
Site Name
High Tech Medical Kft.
Principal Investigator Name
Tamás Gergely Nyéky
Principal Investigator Email
nyekytamas@gmail.com
Contact Person Name
Tamás Gergely Nyéky
Contact Person Email
nyekytamas@gmail.com
Site Name
Complex Rendelo Med Zrt.
Principal Investigator Name
István Reiber
Principal Investigator Email
reiberistvan60@gmail.com
Contact Person Name
István Reiber
Contact Person Email
reiberistvan60@gmail.com
Site Name
Semmelweis University
Department Name
Városmajori Szív- és Érgyógyászati Klinika
Principal Investigator Name
Béla Merkely
Principal Investigator Email
merkely.bela@kardio.sote.hu
Contact Person Name
Béla Merkely
Contact Person Email
merkely.bela@kardio.sote.hu
Site Name
Obudai Egeszseguegyi Centrum Kft.
Principal Investigator Name
Viktor Vass
Principal Investigator Email
vassviktor@yahoo.com
Contact Person Name
Viktor Vass
Contact Person Email
vassviktor@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
21-07-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
130
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Internal Medicine
Principal Investigator Name
Luis Beltrán
Principal Investigator Email
luism.beltranromero@gmail.com
Contact Person Name
Luis Beltrán
Contact Person Email
luism.beltranromero@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Lipidology
Principal Investigator Name
Jose Luis Diaz Diaz
Principal Investigator Email
jose.luis.diaz.diaz@sergas.es
Contact Person Name
Jose Luis Stroes? (contact listed: E.S.Stroes@amsterdamumc.nl is Netherlands) -- contact for Spain: Jose Luis Diaz Diaz
Contact Person Email
jose.luis.diaz.diaz@sergas.es
Site Name
Salut Sant Joan De Reus
Department Name
Lipidology
Principal Investigator Name
Daia Ibarretxe Gerediaga
Principal Investigator Email
daiana.ibarretxe@salutsantjoan.cat
Contact Person Name
Daia Ibarretxe Gerediaga
Site Name
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Department Name
Lipidology
Principal Investigator Name
Ramon Estruch Riba
Principal Investigator Email
restruch@ub.edu
Contact Person Name
Ramon Estruch Riba
Contact Person Email
restruch@ub.edu
Site Name
Hospital Universitario Reina Sofia
Department Name
Lipidology
Principal Investigator Name
Francisco José Fuentes Jimenez
Principal Investigator Email
fjfuentesjimenez@yahoo.es
Contact Person Name
Francisco José Fuentes Jimenez
Contact Person Email
fjfuentesjimenez@yahoo.es

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
AZD0780
Active Substance
LAROPROVSTAT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Investigational
Investigational Product Name
AZD0780 Placebo
Modality
Other
Combination Treatment
Yes

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