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Viking TherapeuticsSafety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease Fase II 59
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La sperimentazione clinica NCT02927184 è stata uno studio interventistico di Fase II condotto per esaminare il trattamento per Iperlipidemia, NAFLD, attualmente completato. Avviato il 28 settembre 2016, ha previsto l'arruolamento di 59 partecipanti. Sotto la guida di Viking Therapeutics, si è concluso il 26 marzo 2019. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 26 aprile 2021.
Sommario breve
This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of the treatment period (Week 12). Secondary endpoints include effects on liver fat content and other liver and lipid markers, as well as effects on safe...Mostra di più
Titolo ufficiale
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess The Efficacy, Safety, and Tolerability of VK2809 Administered for 12 Weeks Followed by a 4-Week Off-Drug Phase in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Patologie
IperlipidemiaNAFLDAltri ID dello studio
- VK2809-201
Numero NCT
Data di inizio (effettiva)
2016-09-28
Ultimo aggiornamento pubblicato
2021-04-26
Data di completamento (stimata)
2019-03-26
Arruolamento (previsto)
59
Tipo di studio
Interventistico
FASE
Fase II
Stato
Completato
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore placeboPlacebo Placebo capsule | PLACEBO |
SperimentaleVK2809 (5mg) 5mg VK2809 capsule | VK2809 |
SperimentaleVK2809 (10mg) 10mg VK2809 capsule | VK2809 |
SperimentaleVK2809 (10mg QOD) 10mg VK2809 capsule | VK2809 |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in LDL-C in patients receiving VK2809 compared to placebo | 12 weeks |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Minimum of 10% liver fat as assessed by MRI - Proton Density Fat Fraction
Fasting serum LDL-C >130 mg/dL at screening, >110 mg/dL on lipid lowering medications
Any one of the following:
- Triglycerides ≥150 mg/dL or receiving prescription medication for elevated triglycerides.
- Systolic blood pressure >130 mmHg or diastolic blood pressure ≥85 mmHg or receiving prescription medication for hypertension.
- Waist circumference >40 inches (men) or >35 inches (women)
Body mass index (BMI) 18.50 - 40.00 kg/m2 inclusive at screening
Provide a personally-signed and dated informed consent document
- Females of childbearing potential and males unwilling to use barrier birth control method (condom) throughout the study
- Resting 12-lead ECG showing QTc >450 msec, any tachyarrhythmia or morphology change, or any other clinically significant abnormality
- Cardiovascular event requiring hospitalization in the past year
- History or presence of thyroid disorder
- History of malignancy in past 5 years
- LDL-C ≥190 mg/dL or familial hypercholesterolemia
- Significant hepatic or renal function test abnormalities
Viking TherapeuticsNessun dato di contatto
19 Centri dello studio in 1 paesi
Arizona
Radiant Research, Inc., Chandler, Arizona, 85224, United States
California
SC Clinical Research, Garden Grove, California, 92844, United States
ACTCA, Los Angeles, California, United States
Catalina Research Institute, Montclair, California, 91763, United States
North America Research, Inc, Pomona, California, 91767, United States
Orange County Research Center, Tustin, California, 92780, United States
Florida
Research Institute of South Florida, Miami, Florida, 33173, United States
Research Institute of South Florida, Miami, Florida, United States
Louisiana
Avant Research Associates, LLC, Crowley, Louisiana, 70526, United States
Massachusetts
HCI- MetroMedic Walk-in, New Bedford, Massachusetts, 02740, United States
HCI- MetroMedic Walk-in, New Bedford, Massachusetts, United States
Michigan
Flint Clinical Research, PLLC, Flint, Michigan, 48503, United States
New York
Mid Hudson Medical, Hopewell Junction, New York, 12533, United States
CHEAR Center, LLC, The Bronx, New York, 10459, United States
North Carolina
Wake Research Associcates, LLC., Raleigh, North Carolina, 27612, United States
Texas
Avant Research, Beaumont, Texas, 77702, United States
Clinical Trials of Texas, INC, San Antonio, Texas, 78229, United States
Radiant Research, Inc., San Antonio, Texas, 78229, United States
Utah
Wasatch Clinical Research, LLC, Salt Lake City, Utah, 84107, United States