Clinical trial NCT06347133: Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Official title: Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypertriglyceridemia
Lead sponsor: Arrowhead Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 1328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L)
* 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
* Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening
* Screening HbA1c ≤8.5%
* Willing to follow diet counseling and maintain a stable low-fat diet
* Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator)

Exclusion Criteria:

* Use of any hepatocyte-targeted small interfering ribonucleic acid (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.
* 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 pharmacokinetics (PK), whichever is longer
* Acute pancreatitis within 4 weeks prior to screening
* Body mass index \>45 kg/m\^2

Note: Additional Inclusion/Exclusion criteria may apply per protocol

Primary outcomes:
measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
timeFrame: Baseline, Month 10
measure: Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo
timeFrame: Month 10, Month 12
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo
timeFrame: From first dose of study drug through Month 12
measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment
timeFrame: From first dose of study drug through Month 12
measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment
timeFrame: From first dose of study drug through Month 12
measure: Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo
timeFrame: From first dose of study drug through Month 12
measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo
timeFrame: From first dose of study drug through Month 12
measure: Change from Baseline in C-peptide During the Treatment Period Compared to Placebo
timeFrame: From first dose of study drug through Month 12
measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo
timeFrame: From first dose of study drug through Month 12
measure: Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo
timeFrame: From first dose of study drug through Month 12
measure: Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo
timeFrame: From first dose of study drug through Month 12
measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo
timeFrame: From first dose of study drug through Month 12
measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12
timeFrame: From first dose of study drug through Month 12
measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12
timeFrame: From first dose of study drug through Month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ascension St. Vincents Birmingham
state: Alabama
city: Mobile
country: United States
facility: IMC Diagnostic and Medical Clinic, LLC
state: Alabama
city: Beverly Hills
country: United States
facility: National Heart Institute
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Garden Grove
country: United States
facility: National Institute of Clinical Research
state: California
city: Huntington Beach
country: United States
facility: National Institute of Clinical Research, Inc.
state: California
city: Lake Forest
country: United States
facility: Orange County Research Center, Inc.
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Oxnard
country: United States
facility: Fomat Medical Research, Inc.
state: California
city: Panorama City
country: United States
facility: Velocity Clinical Research, Panorama City
state: California
city: Redding
country: United States
facility: The Cardiovascular Center
state: California
city: Colorado Springs
country: United States
facility: Legacy Clinical Trials
state: Colorado
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Hialeah
country: United States
facility: Neoclinical Research
state: Florida
city: Lake City
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Mount Dora
country: United States
facility: Adult Medicine of Lake County
state: Florida
city: North Miami
country: United States
facility: Harmony Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital Cardiology
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center of Sarasota Foundation for Research and Education
state: Florida
city: Tamarac
country: United States
facility: TBC Research
state: Florida
city: Lawrenceville
country: United States
facility: Georgia Clinical Research Center, Inc.
state: Georgia
city: Macon
country: United States
facility: East Coast Institute For Research, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Sugar Hill
country: United States
facility: RNA America Health Sciences
state: Georgia
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Elkhart
country: United States
facility: Midwest Cardiovascular Research and Education Foundation
state: Indiana
city: Indianapolis
country: United States
facility: Ascension St. Vincent Heart Center
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic LLC
state: Indiana
city: Overland Park
country: United States
facility: Midwest Heart & Vascular Specialists
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Stormont-Vail West
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Research Foundation
state: Kentucky
city: Metairie
country: United States
facility: Southern Clinical Research
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Internal Medicine
state: Maryland
city: Baltimore
country: United States
facility: Ascension Saint Agnes Heart Care
state: Maryland
city: Flint
country: United States
facility: Elite Clinical Research Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Jefferson City
country: United States
facility: Jefferson City Medical Group PC
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Norfolk
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Methodist Physicians Clinic Heart Consultants
state: Nebraska
city: Omaha
country: United States
facility: Midwest Regional Health Services LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Santa Rosa Medical Centers of Nevada
state: Nevada
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Bronx
country: United States
facility: CHEAR Center LLC
state: New York
city: Bronx
country: United States
facility: Jack D Weike Hospital
state: New York
city: New York
country: United States
facility: CTSI Investigational Pharmacy
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Riverhead
country: United States
facility: Northwell Health Physician Partners at Peconic
state: New York
city: Rochester
country: United States
facility: University of Rochester - PARENT
state: New York
city: Vestal
country: United States
facility: Velocity Clinical Research-Vestal New York
state: New York
city: Asheboro
country: United States
facility: Triad Internal Medicine
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences, Department of Cardiology
state: North Carolina
city: Beavercreek
country: United States
facility: Internal Medicine Care Inc
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute East
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Sci. Inst.
state: Oklahoma
city: Horsham
country: United States
facility: Abington Medical Specialists, P.C.
state: Pennsylvania
city: Newport
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Fort Mill
country: United States
facility: Piedmont Research Partners
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: University Diabetes and Endocrine Consultants
state: Tennessee
city: Powell
country: United States
facility: Cardiovascular Research Center of Knoxville
state: Tennessee
city: El Paso
country: United States
facility: David Turbay, MD, PLLC
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: Gonzalez Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Juno Research LLC
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network LLC
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Houston
country: United States
facility: Synergy Groups Medical LLC
state: Texas
city: Houston
country: United States
facility: Spring Clinical Research
state: Texas
city: Houston
country: United States
facility: Endocrine and Psychiatry Center
state: Texas
city: Laredo
country: United States
facility: Andres Garcia Zuniga MD PA
state: Texas
city: Missouri City
country: United States
facility: Synergy Groups Medical
state: Texas
city: Plano
country: United States
facility: Stryde Research
state: Texas
city: San Antonio
country: United States
facility: VIP Trials
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice
state: Texas
city: Tomball
country: United States
facility: Northwest Houston Heart Center
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine
state: Utah
city: Saint George
country: United States
facility: Chrysalis Clinical Research, LLC
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Seattle
country: United States
facility: UW Medicine Diabetes Institute Clinical Research Unit
state: Washington
city: Caba
country: Argentina
facility: Expertia S.A- Mautalen Salud e Investigación
state: Buenos Aires
city: Caba
country: Argentina
facility: Centro Privado de Medicina Familiar - Mind Out Research
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Glenny Corp. S.A.
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Sanatorio Privado Duarte Quiroz De Clinica Colombo SA
state: Cordoba
city: Córdoba
country: Argentina
facility: Centro Medico Luquez
state: Cordoba
city: Godoy Cruz
country: Argentina
facility: CIPADI
state: Mendoza
city: Rosario
country: Argentina
facility: Instituto CAICI
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas de Rosario
state: Santa Fe
city: Blacktown
country: Australia
facility: Paratus Clinical Research, Western Sydney
state: New South Wales
city: Merewether
country: Australia
facility: The Aim Centre
state: New South Wales
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Blagoevgrad
country: Bulgaria
facility: MHAT Puls AD
city: Burgas
country: Bulgaria
facility: Medical Center 4LIFE EOOD
city: Byala
country: Bulgaria
facility: MHAT Yuliya Vrevska - Byala, EOOD
city: Dimitrovgrad
country: Bulgaria
facility: Medical Center Diamedical - 2013 OOD
city: Haskovo
country: Bulgaria
facility: MHAT-Haskovo, AD
city: Kyustendil
country: Bulgaria
facility: Medical Center Hera - Kyustendil
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult Pleven OOD
city: Pleven
country: Bulgaria
facility: MHAT Heart and Brain - Pleven
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela, EOOD
city: Plovdiv
country: Bulgaria
facility: UMHAT Pulmed OOD
city: Plovdiv
country: Bulgaria
facility: MHAT Sv. Karidad, EAD
city: Ruse
country: Bulgaria
facility: MC Rusemed ltd.
city: Sevlievo
country: Bulgaria
facility: Medical Center Unimed EOOD
city: Sofia
country: Bulgaria
facility: Second Medical Center
city: Sofia
country: Bulgaria
facility: MHAT Lyulin EAD
city: Sofia
country: Bulgaria
facility: Medical Center 'Acad. I. Penchev', EOOD
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska EAD
city: Sofia
country: Bulgaria
facility: UMHAT Sveta Ekaterina
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Ioanna ISUL Cardiology clinic
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Yoanna - ISUL EAD
city: Sofia
country: Bulgaria
facility: Medical Center Sv. Dimitar
city: Sofia
country: Bulgaria
facility: MHAT Sv. Sofia, OOD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultation Center CONVEX EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Kalimat
city: Sofia
country: Bulgaria
facility: UMHAT SofiaMed, OOD
city: Stara Zagora
country: Bulgaria
facility: Medical Center ZARA-MED EOOD
city: North Vancouver
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Victoria
country: Canada
facility: Discovery Clinical Services Ltd.
state: British Columbia
city: Brampton
country: Canada
facility: Centricity Research Brampton
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Waterloo
country: Canada
facility: Clinical Research Solutions Inc.
state: Ontario
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Laval
country: Canada
facility: Centre de Recherche Clinique de Laval
state: Quebec
city: Montréal
country: Canada
facility: Institut De Recherche Clinique De Montreal
state: Quebec
city: Québec
country: Canada
facility: Clinique des Maladies Lipidiques de Quebec
state: Quebec
city: Québec
country: Canada
facility: Centre de Medicine Metabolique de Lanaudiere
state: Quebec
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
city: Quebec
country: Canada
facility: Recherche Clinique Sigma Inc
city: Praha 4
country: Czechia
facility: Institut klinicke a experimentalni mediciny
state: Prague
city: Brno
country: Czechia
facility: Fakultni nemocnice u svate Anny v Brne, I. Interni kardioangiologicka klinika
city: Hodonín
country: Czechia
facility: CTC Hodonin s.r.o.
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Náchod
country: Czechia
facility: EDUMED, s.r.o.
city: Olomouc
country: Czechia
facility: PreventaMed s.r.o.
city: Ostrava
country: Czechia
facility: CCR Ostrava s.r.o.
city: Praha 10
country: Czechia
facility: MUDr. Jan KVASNICKA CSc.
city: Praha 4-Krc
country: Czechia
facility: Fakultni Thomayerova nemocnice
city: Slaný
country: Czechia
facility: Nemocnice Slany
city: Teplice
country: Czechia
facility: Unilabs Diagnostics, k.s
city: Trutnov
country: Czechia
facility: Kardiologicka ambulance MUDr. Ferkl s.r.o.
city: Uherské Hradiště
country: Czechia
facility: MEDICAL PLUS s.r.o.
city: Ústí Nad Labem
country: Czechia
facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille AP HM Hopital de La Conception
state: Bouches Du Rhone
city: Pessac
country: France
facility: Groupe Hospitalier Sud Hôpital Haut-Lévêque
state: Gironde
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
state: Rhone
city: Paris
country: France
facility: APHP Hôpital Universitaire Pitié Salpêtrière
city: Deggingen
country: Germany
facility: Gemeinschaftspraxis Dres. Jung
state: Baden Wuerttemberg
city: Wallerfing
country: Germany
facility: Gemeinschaftspraxis Dr. Josef Grosskopf und Dr. Wilma Grosskopf
state: Bayern
city: Magdeburg
country: Germany
facility: SMO.MD GmbH
state: Sachsen Anhalt
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Budapest
country: Hungary
facility: Belvaros-Lipotvaros Egeszsegugyi Szolgalat
city: Budapest
country: Hungary
facility: Privat Doktor Zrt.
city: Budapest
country: Hungary
facility: UNO Medical Trials Kft.
city: Békéscsaba
country: Hungary
facility: Belgyogyaszati es Kardiologiai Maganrendelo
city: Kaposvar
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Miskolc
country: Hungary
facility: IPR Hungary Kft.
city: Pécs
country: Hungary
facility: COROMed-SMO Kft.
city: Pécs
country: Hungary
facility: Da Vinci Magánklinika
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Veszprém
country: Hungary
facility: Minoseg Orvoscsoport Kft
city: Zalaegerszeg
country: Hungary
facility: Belvarosi Egeszseghaz Kft.
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
state: Milano
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
state: Sicily
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Presidio Spedali Civili
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
city: Bydgoszcz
country: Poland
facility: MICS Centrum Medyczne Bydgoszcz
city: Bydgoszcz
country: Poland
facility: NZOZ Centrum Medyczne KERmed
city: Elbląg
country: Poland
facility: Centrum Kliniczno - Badawcze J. Brzezicki B. Gornikiewicz-Brzezicka Lekarze Społka Partnerska
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
city: Katowice
country: Poland
facility: Clinical Medical Research Sp. z o.o.
city: Kraków
country: Poland
facility: Pratia MCM Krakow
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne
city: Malbork
country: Poland
facility: Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp z o.o.
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Toruń
country: Poland
facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
city: Warsaw
country: Poland
facility: FutureMeds Warszawa Centrum
city: Warsaw
country: Poland
facility: FutureMeds Targowek
city: Wrocław
country: Poland
facility: NZOZ Zdrowie s.c. Agnieszka i Donald Drożdż
city: Wrocław
country: Poland
facility: CM Sedimed Wroclaw
city: Wrocław
country: Poland
facility: FutureMeds Wroclaw
city: Zamość
country: Poland
facility: Velocity Zamosc
city: Łódź
country: Poland
facility: FutureMeds Lodz
city: Łódź
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska
city: Żarów
country: Poland
facility: Centrum Medyczne Serafin med
city: Banská Bystrica
country: Slovakia
facility: Kardiointerna s r o
city: Bardejov
country: Slovakia
facility: Alian s.r.o.
city: Bratislava
country: Slovakia
facility: Kardiologická ambulancia Cliniq s.r.o.
city: Bratislava
country: Slovakia
facility: Kardiovaskularne centrum, s.r.o.
city: Košice
country: Slovakia
facility: Kardiologicka a interna ambulancia
city: Moldava Nad Bodvou
country: Slovakia
facility: Kardiologicka ambulancia MEDI MandM s.r.o.
city: Nové Zámky
country: Slovakia
facility: Kardiologicka ambulancia Cardioamb s.r.o.
city: Prešov
country: Slovakia
facility: Medispol s.r.o.
city: Roznava
country: Slovakia
facility: Tatratrial s.r.o.
city: Centurion
country: South Africa
facility: Dr IO Ebrahim Inc
state: Gauteng
city: Krugersdorp
country: South Africa
facility: DJW Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Diabetes Care Centre
state: Gauteng
city: Durban
country: South Africa
facility: Dr Jeevren Reddys Surgery
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Corbod Research PTY Ltd
state: Western Cape
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Langeberg Clinical Trials
state: Western Cape
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital Lipid Laboratory
state: Western Cape
city: Somerset West
country: South Africa
facility: Dr JM Engelbrecht Trial Site
state: Western Cape
city: Pretoria
country: South Africa
facility: RYEXO Clinical Research
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
state: La Coruña
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
state: Devon
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
References: