Clinical trial • Phase III • Cardiology
INCLISIRAN for Heterozygous familial hypercholesterolemia
Phase III trial of INCLISIRAN for Heterozygous familial hypercholesterolemia.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Heterozygous familial hypercholesterolemia
- Trial Stage
- Phase III
- Drug Modality
- Other RNA
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 25-09-2024
- First CTIS Authorization Date
- 04-02-2025
Trial design
Randomised, open-label, active: kjx839 (inclisiran, investigational product). comparator: placebo to kjx839 (inclisiran) 0 mg/1.5 ml solution for injection in vial (placebo). dose and detailed schedule not specified in the available ctis data.-controlled Phase III trial across 36 sites in Netherlands, Italy, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Active: KJX839 (inclisiran, investigational product). Comparator: Placebo to KJX839 (Inclisiran) 0 mg/1.5 mL Solution for injection in vial (placebo). Dose and detailed schedule not specified in the available CTIS data.
- Target Sample Size
- 24
- Trial Duration For Participant
- 720
Eligibility
Recruits 24 paediatric patients.
- Pregnancy Exclusion
- Pregnant or nursing females
- Vulnerable Population
- The study population comprises children aged 6 to <12 years (vulnerable population). Informed consent is required from the parent/legal guardian; assent is required from children with age-appropriate assent forms (Pre-Adolescent Assent, Child Assent, Adolescent Assent). Country-specific parent/legal guardian ICFs, assent forms, genetics consent and pregnancy follow-up consent documents are provided.
Inclusion criteria
- {"criterion_text":"- Male or female participants, 6 to <12 years of age at screening"}
- {"criterion_text":"- HeFH diagnosed either by genetic testing or on phenotypic criteria"}
- {"criterion_text":"- Fasting LDL-C >130 mg/dL (3.4 mmol/L) at screening"}
- {"criterion_text":"- For participants 8 to <12 years, on an optimal dose of statin (investigator’s discretion) unless statin intolerant, with or without other lipid-lowering therapy (e.g. ezetimibe). For participants <8 years, the use of background lipid-lowering treatment is based on investigator’s discretion."}
- {"criterion_text":"- Participants on lipid-lowering therapies (such as statin and/or e.g. ezetimibe) must be on a stable dose for ≥30 days before screening with no planned medication or dose changes during study participation."}
Exclusion criteria
- {"criterion_text":"- Previous treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9"}
- {"criterion_text":"- Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome"}
- {"criterion_text":"- Homozygous familial hypercholesterolemia (HoFH)"}
- {"criterion_text":"- Body weight <16 kg at the screening and/or randomization (Day 1) visit"}
- {"criterion_text":"- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation >2x ULN (except patients with Gilbert’s syndrome)"}
- {"criterion_text":"- Pregnant or nursing females"}
- {"criterion_text":"- Recent and/or planned use of other investigational medicinal products or devices"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percentage change in LDL-C from baseline to Day 330 (Year 1)","definition_or_measurement_approach":"Percent change in LDL-C from baseline to Day 330 (Year 1). LDL-C is measured fasting (screening required fasting LDL-C >130 mg/dL) and percent change calculated versus baseline at Day 330."}
Secondary endpoints
- {"endpoint_text":"- Time-adjusted percent change in LDL-C from baseline after Day 90 and up to Day 330 (Year 1)","definition_or_measurement_approach":"Time-adjusted percent change in fasting LDL-C measured after Day 90 up to Day 330 (Year 1)."}
- {"endpoint_text":"- Absolute change in LDL-C from baseline to Day 330 (Year 1)","definition_or_measurement_approach":"Absolute change in fasting LDL-C from baseline to Day 330."}
- {"endpoint_text":"- Percent change in PCSK9, total cholesterol, Apo B, and non-HDL-C from baseline to Day 330 (Year 1)","definition_or_measurement_approach":"Percent change from baseline to Day 330 for PCSK9, total cholesterol, apolipoprotein B and non-HDL-C (laboratory measurements)."}
- {"endpoint_text":"- Percent change and absolute change in LDL-C, PCSK9, total cholesterol, Apo B, non-HDL-C, lipoprotein (a) [Lp(a)], triglycerides, high density lipoprotein cholesterol (HDL-C), very low density lipoprotein cholesterol (VLDL-C), and apolipoprotein A1 (Apo A1) from baseline to each assessment time up to Day 720 (Year 2)","definition_or_measurement_approach":"Percent and absolute changes from baseline to each scheduled assessment up to Day 720 for the listed lipid and biomarker parameters."}
- {"endpoint_text":"- Incidence, severity and relationship to study drug of treatment-emergent adverse events (AEs) and serious adverse events (SAEs); vital signs; laboratory parameters; anti-drug antibodies (ADA) measurement; growth (height, weight, body mass index (BMI)); pubertal development (sexual hormones and Tanner staging)","definition_or_measurement_approach":"Safety assessments include recording treatment-emergent AEs/SAEs, vital signs, laboratory tests, ADA measurement, growth parameters (height, weight, BMI) and pubertal development (hormone measurements and Tanner staging) through the study period."}
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 58
- Consent Approach
- Informed consent is provided by the parent/legal guardian (Parent Legal Guardian ICFs). Age-appropriate assent is obtained using Pre-Adolescent Assent, Child Assent or Adolescent Assent forms as applicable. Separate genetics consent and pregnancy follow-up consent documents are available. Consent/assent documents are provided in country-specific languages (examples in dossier include Dutch, Italian, Polish, Czech, German, Spanish, French, Portuguese, Greek, Hungarian and English).
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 37
Netherlands
- Earliest CTIS Part Ii Submission Date
- 06-01-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 473
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- 3450: Pediatric Metabolic Diseases
- Principal Investigator Name
- Willemijn Corpeleijn
- Principal Investigator Email
- w.e.corpeleijn@amsterdamumc.nl
- Contact Person Name
- Willemijn Corpeleijn
- Contact Person Email
- w.e.corpeleijn@amsterdamumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 23-12-2024
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 491
- Number Of Sites
- 4
- Number Of Participants
- 3
Sites
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- 3801: Centro Dislipidemie
- 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 Integrata Verona
- Department Name
- 3803:Dipartimento Ospedale della Donna e del Bambino
- Principal Investigator Name
- Claudio Maffeis
- Principal Investigator Email
- claudio.maffeis@univr.it
- Contact Person Name
- Claudio Maffeis
- Contact Person Email
- claudio.maffeis@univr.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- 3804: Endocrinologia pediatrica
- Principal Investigator Name
- Luisa De Sanctis
- Principal Investigator Email
- luisa.desanctis@unito.it
- Contact Person Name
- Luisa De Sanctis
- Contact Person Email
- luisa.desanctis@unito.it
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- 3800: U.O.C. Clinical Trial Center
- Principal Investigator Name
- Paola Sabrina Buonuomo
- Principal Investigator Email
- psabrina.buonuomo@opbg.net
- Contact Person Name
- Paola Sabrina Buonuomo
- Contact Person Email
- psabrina.buonuomo@opbg.net
Poland
- Earliest CTIS Part Ii Submission Date
- 17-01-2025
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 466
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- 3501: Klinika Pediatrii, Diabetologii i Endokrynologii
- Principal Investigator Name
- Małgorzata Myśliwiec
- Principal Investigator Email
- mysliwiec@gumed.edu.pl
- Contact Person Name
- Małgorzata Myśliwiec
- Contact Person Email
- mysliwiec@gumed.edu.pl
- Site Name
- Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
- Department Name
- 3502: Klinika Pediatrii, Reumatologii, Immunologii i Chorób Metabolicznych Kości
- Principal Investigator Name
- Radosław Motkowski
- Principal Investigator Email
- radoslaw.motkowski@umb.edu.pl
- Contact Person Name
- Radosław Motkowski
- Contact Person Email
- radoslaw.motkowski@umb.edu.pl
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- 3500: Regionalne Centrum Chorób Rzadkich
- Principal Investigator Name
- Ewa Starostecka
- Principal Investigator Email
- ewastarostecka@wp.pl
- Contact Person Name
- Ewa Starostecka
- Contact Person Email
- ewastarostecka@wp.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 23-12-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 490
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- 2950:Klinika pediatrie a dědičných poruch metabolismu
- Principal Investigator Name
- Jan Jesina
- Principal Investigator Email
- Pavel.Jesina@vfn.cz
- Contact Person Name
- Jan Jesina
- Contact Person Email
- Pavel.Jesina@vfn.cz
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- 2951:ULCHKB
- Principal Investigator Name
- Jana Cepova
- Principal Investigator Email
- Jana.Cepova@fnmotol.cz
- Contact Person Name
- Jana Cepova
- Contact Person Email
- Jana.Cepova@fnmotol.cz
Austria
- Earliest CTIS Part Ii Submission Date
- 10-01-2025
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 473
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
- Department Name
- Department of pediatrics and adolescent medicine
- Principal Investigator Name
- Katharina Moerwald
- Principal Investigator Email
- k.moerwald@salk.at
- Contact Person Name
- Katharina Moerwald
- Contact Person Email
- k.moerwald@salk.at
- Site Name
- Medical University Of Vienna
- Department Name
- Department of pediatrics and adolescent medicine
- Principal Investigator Name
- Susanne Greber-Platzer
- Principal Investigator Email
- susanne.greber-platzer@meduniwien.ac.at
- Contact Person Name
- Susanne Greber-Platzer
- Contact Person Email
- susanne.greber-platzer@meduniwien.ac.at
Spain
- Earliest CTIS Part Ii Submission Date
- 23-12-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 490
- Number Of Sites
- 9
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- 3658: Pediatría
- Principal Investigator Name
- Victor Manuel Navas Lopez
- Principal Investigator Email
- victor.navas@gmail.com
- Contact Person Name
- Victor Manuel Navas Lopez
- Contact Person Email
- victor.navas@gmail.com
- Site Name
- Hospital General Universitario De Elche
- Department Name
- 3653: Pediatría
- Principal Investigator Name
- José Pastor Delgado
- Principal Investigator Email
- pastor_jos@gva.es
- Contact Person Name
- José Pastor Delgado
- Contact Person Email
- pastor_jos@gva.es
- Site Name
- Hospital Universitario De Navarra
- Department Name
- 3655: Pediatría
- Principal Investigator Name
- Maria Jesús Chueca Guindulain
- Principal Investigator Email
- mchuecag@cfnavarra.es
- Contact Person Name
- Maria Jesús Chueca Guindulain
- Contact Person Email
- mchuecag@cfnavarra.es
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- 3657: Pediatría
- Principal Investigator Name
- Silvia Meavilla Olivas
- Principal Investigator Email
- silviamaria.meavilla@sjd.es
- Contact Person Name
- Silvia Meavilla Olivas
- Contact Person Email
- silviamaria.meavilla@sjd.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- 3651: Pediatría
- Principal Investigator Name
- Gemma Carreras González
- Principal Investigator Email
- GCarreras@santpau.cat
- Contact Person Name
- Gemma Carreras González
- Contact Person Email
- GCarreras@santpau.cat
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- 3656: Pediatría
- Principal Investigator Name
- Aina Valls Llussà
- Principal Investigator Email
- avalls.germanstrias@gencat.cat
- Contact Person Name
- Aina Valls Llussà
- Contact Person Email
- avalls.germanstrias@gencat.cat
- Site Name
- Hospital Universitario Puerta Del Mar
- Department Name
- 3652: Pediatría
- Principal Investigator Name
- Jesús Domínguez Riscart
- Principal Investigator Email
- jesus.dominguezriscart@gmail.com
- Contact Person Name
- Jesús Domínguez Riscart
- Contact Person Email
- jesus.dominguezriscart@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- 3650: Pediatría
- Principal Investigator Name
- Emilio José García García
- Principal Investigator Email
- emilioj.garcia.sspa@juntadeandalucia.es
- Contact Person Name
- Emilio José García García
- Contact Person Email
- emilioj.garcia.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario De Navarra (duplicate entry in list)
- Department Name
- 3655: Pediatría
- Principal Investigator Name
- Maria Jesús Chueca Guindulain
- Principal Investigator Email
- mchuecag@cfnavarra.es
- Contact Person Name
- Maria Jesús Chueca Guindulain
- Contact Person Email
- mchuecag@cfnavarra.es
Belgium
- Earliest CTIS Part Ii Submission Date
- 25-12-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 485
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- 2901 : Paediatrics - Paediatric Hepatology
- Principal Investigator Name
- Xavier Stephenne
- Principal Investigator Email
- xavier.stephenne@saintluc.uclouvain.be
- Contact Person Name
- Xavier Stephenne
- Contact Person Email
- xavier.stephenne@saintluc.uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- 2900 : Paediatrics - Metabolic Diseases
- Principal Investigator Name
- Peter Witters
- Principal Investigator Email
- Peter.witters@uzleuven.be
- Contact Person Name
- Peter Witters
- Contact Person Email
- Peter.witters@uzleuven.be
Hungary
- Earliest CTIS Part Ii Submission Date
- 06-12-2024
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 509
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- University Of Pecs
- Department Name
- 3301: Gyermekgyogyaszati Klinika
- Principal Investigator Name
- Decsi Tamas
- Principal Investigator Email
- decsi.tamas@pte.hu
- Contact Person Name
- Decsi Tamas
- Contact Person Email
- decsi.tamas@pte.hu
- Site Name
- Cortex Study Center
- Department Name
- 3300: Gyermekgyogyaszat
- Principal Investigator Name
- Szamosi Tamas
- Principal Investigator Email
- szamosi.tamas@semmelweis.hu
- Contact Person Name
- Szamosi Tamas
- Contact Person Email
- szamosi.tamas@semmelweis.hu
Germany
- Earliest CTIS Part Ii Submission Date
- 03-01-2025
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 479
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- 3153 : Zentrum für Kinder- und Jugendmedizin
- Principal Investigator Name
- Clemens Kamrath
- Principal Investigator Email
- clemens.kamrath@uniklinik-freiburg.de
- Contact Person Name
- Clemens Kamrath
- Contact Person Email
- clemens.kamrath@uniklinik-freiburg.de
- Site Name
- Hannoversche Kinderheilanstalt
- Department Name
- 3152 : Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung
- Principal Investigator Name
- Olga Kordonouri
- Principal Investigator Email
- Kordonouri@hka.de
- Contact Person Name
- Olga Kordonouri
- Contact Person Email
- Kordonouri@hka.de
- Site Name
- Goethe University Frankfurt
- Department Name
- 3150 : Universitaetsklinikum Frankfurt Klinik für Kinder- und Jugendmedizin
- Principal Investigator Name
- Ulrich Paetow
- Principal Investigator Email
- paetow@med.uni-frankfurt.de
- Contact Person Name
- Ulrich Paetow
- Contact Person Email
- paetow@med.uni-frankfurt.de
France
- Earliest CTIS Part Ii Submission Date
- 08-11-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 532
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- 3051:ENDOCRINOLOGIE MALADIES METABOLIQUES 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
- Site Name
- Centre Hospitalier Universitaire De Nantes (Saint Herblain site)
- Department Name
- 3051:ENDOCRINOLOGIE MALADIES METABOLIQUES 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
- Site Name
- Trousseau Hospital
- Department Name
- 3050:GASTRO-ENTERO PEDIATRIQUE
- Principal Investigator Name
- Julie LEMALE
- Principal Investigator Email
- julie.lemale@aphp.fr
- Contact Person Name
- Julie LEMALE
- Contact Person Email
- julie.lemale@aphp.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- 3052:HOPITAL LA TIMONE ENFANTS SCE DE PEDIATRIE MULTIDISCIPLINAIRE
- Principal Investigator Name
- Rachel REYNAUD
- Principal Investigator Email
- Rachel.REYNAUD@ap-hm.fr
- Contact Person Name
- Rachel REYNAUD
- Contact Person Email
- Rachel.REYNAUD@ap-hm.fr
Portugal
- Earliest CTIS Part Ii Submission Date
- 28-11-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 512
- Number Of Sites
- 4
- Number Of Participants
- 3
Sites
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- 3551: Serviço de Pediatria
- Principal Investigator Name
- Mónica Tavares
- Principal Investigator Email
- U09412@chporto.min-saude.pt
- Contact Person Name
- Mónica Tavares
- Contact Person Email
- U09412@chporto.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- 3550: Serviço de Pediatria
- Principal Investigator Name
- Rita Isabel Roussado José Jotta de Oliveira
- Principal Investigator Email
- Rita.oliveira@ulssm.min-saude.pt
- Contact Person Name
- Rita Isabel Roussado José Jotta de Oliveira
- Contact Person Email
- Rita.oliveira@ulssm.min-saude.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- 3552: Serviço de Pediatria
- Principal Investigator Name
- Raquel Soares
- Principal Investigator Email
- Raquelsoares@ulscoimbra.min-saude.pt
- Contact Person Name
- Raquel Soares
- Contact Person Email
- Raquelsoares@ulscoimbra.min-saude.pt
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- 3554: Serviço de Pediatria
- Principal Investigator Name
- Susana Mesquita de Campos Corujeira
- Principal Investigator Email
- Susanamcorujeira@gmail.com
- Contact Person Name
- Susana Mesquita de Campos Corujeira
- Contact Person Email
- Susanamcorujeira@gmail.com
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA RDS Hellas Single Member S.A.
- Responsibilities
- Start up CTA role actions
- Name
- IQVIA Limited
- Name
- Icon Clinical Research Limited
- Name
- Syneos Health Inc.
- Name
- Parexel International (IRL) Limited
- Name
- Medpace Inc.
- Name
- WCG Clinical Inc.
- Name
- Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
- Name
- Medpace Laboratories Singapore
Third parties
- {"country":"Austria","full_name":"ABF Pharmaceutical Services GmbH","duties_or_roles":"Local depot for torage and distribution of AxMP, to sites andDestruction of IMP/AxMP","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Start up CTA role actions","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Shanghai Xiawei Medical Laboratory Co. Ltd.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Medpace Reference Laboratories China","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Singapore","full_name":"Medpace Laboratories Singapore","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Simpleshow USA Corp.","duties_or_roles":"Production of patient engagement video material","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Medpace Reference Laboratories China (duplicate entry)","duties_or_roles":"","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- INCLISIRAN
- Active Substance
- INCLISIRAN
- Modality
- Other RNA
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Maximum Dose
- 600 mg
- Investigational Product Name
- KJX839
- Active Substance
- INCLISIRAN
- Modality
- Other RNA
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Maximum Dose
- 1500 mg
- Investigational Product Name
- Placebo to KJX839 (Inclisiran) 0 mg/1.5 mL Solution for injection in vial
- Modality
- Other
- Combination Treatment
- Yes
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