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O estudo clínico NCT04173065 (VOYAGE) para NASH - Esteato-hepatite Não Alcoólica está concluído. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH (VOYAGE) Fase II 248 Duplo-cego

Concluído
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O estudo clínico NCT04173065 (VOYAGE) avaliou tratamento para NASH - Esteato-hepatite Não Alcoólica. Foi um estudo intervencionista de Fase II. Seu status atual é: concluído. O estudo iniciou em 15 de novembro de 2019 e incluiu 248 participantes. Coordenado por Viking Therapeutics e foi concluído em 26 de janeiro de 2024. Essas informações foram atualizadas no ClinicalTrials.gov em 14 de junho de 2024.
Resumo
The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three hundred thirty-seven subjects will be enrolled into five treatme...Mostrar mais
Título oficial

VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis

Condições médicas
NASH - Esteato-hepatite Não Alcoólica
Outros IDs do estudo
  • VOYAGE
  • VK2809-202
Número NCT
Data de início (real)
2019-11-15
Última atualização postada
2024-06-14
Data de conclusão (estimada)
2024-01-26
Inscrição (estimada)
248
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Concluído
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Quádruplo-cego
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Comparador placeboPlacebo
Placebos
Capsule
Experimental1.0 mg
VK2809
Capsule
Experimental2.5mg
VK2809
Capsule
Experimental5.0 mg
VK2809
Capsule
Experimental10 mg
VK2809
Capsule
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Liver Fat
Relative change in liver fat content (assessed by MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809 compared to the change in subjects treated with placebo.
12 weeks
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
NASH CRN fibrosis score
Proportion of subjects with resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH CRN fibrosis score.
52 weeks
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  1. Provide a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study and is willing and able to participate;

  2. Have a histologically-confirmed diagnosis of NASH on a liver biopsy performed during screening or within 6 months before screening; for this study, confirmation requires:

    1. NASH Clinical Research Network (CRN) fibrosis stage 1 to stage 3 and
    2. NASH activity score (NAS) of ≥4 with at least a score of 1 in each of the following NAS components: ballooning degeneration (score = 0-2), lobular inflammation (score = 0-3) and steatosis (score = 0-3); (c) F1 subjects must have at least one of these risk factors: type 2 diabetes, body mass index of ≥ 30 mg/ m2, and/ or alanine aminotransferase > 1.5 x ULN
  3. Have a screening MRI-PDFF with ≥ 8% liver fat fraction;

  4. Male and females be 18 to 75 years of age, inclusive, at screening;

  1. Are unwilling to undergo the required liver biopsy procedures or have any condition that would prevent obtaining a liver biopsy as part of this clinical protocol
  2. Have evidence of current or history of excessive alcohol consumption of more than 20 g per day for women and 30 g per day for men, on average, within 6 months before the qualifying liver biopsy and up to randomization, or are unable to provide a reliable estimate of alcohol consumption during this period;
  3. Treatment with medications for the purpose of weight loss within 6 months prior to qualifying liver biopsy, unless approved after consultation with the medical monitor. These include drugs approved for weight loss (e.g. orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as drugs used off-label, herbal preparations and dietary supplements marketed for control of body weight or appetite;
  4. TSH outside central laboratory reference range;
  5. Free T4 outside central laboratory reference range;
  6. Cardiac troponin I (cTnI) and creatine kinase MB isoenzyme (CK-MB) > Upper Limit of Normal (ULN) at screening;
  7. Serum albumin < 3.5 g/dL;
  8. International normalized ratio (INR) > 1.3;
  9. Total bilirubin > 1.2 X ULN (except in presence of Gilbert synd
  10. Strong or moderate inhibitors or inducers of CYP3A4 are prohibited during the study period
  11. Drugs that may affect liver fat content or are associated with nonalcoholic fatty liver disease (NAFLD) are prohibited during the 3 month period prior to the baseline liver biopsy and up to the end of treatment
Viking Therapeutics, Inc. logoViking Therapeutics
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79 Locais do estudo em 5 países

Alabama

Viking Clinical Site 105, Madison, Alabama, 35758, United States

Arizona

Viking Clinical Site 216, Glendale, Arizona, 85306, United States
Viking Clinical Site 159, Tucson, Arizona, 85712, United States

Arkansas

Viking Clinical Site 214, North Little Rock, Arkansas, 72117, United States

California

Viking Clinical Site 161, Fresno, California, 93701, United States
Viking Clinical Site 208, Fresno, California, 93720, United States
Viking Clinical Site 302, La Jolla, California, 92037, United States
Viking Clinical Site 134, Montclair, California, 91736, United States
Viking Clinical Site 205, Panorama City, California, 91402, United States
Viking Clinical Site 125, Pasadena, California, 91105, United States
Viking Clinical Site 110, Rialto, California, 92377, United States
Viking Clinical Site 117, Sacramento, California, 95817, United States
Viking Clinical Site 121, San Diego, California, 92037, United States
Viking Clinical Site 103, San Francisco, California, 94115, United States

Connecticut

Viking Clinical Site 156, New Haven, Connecticut, 06510, United States

Florida

Viking Clinical Site 226, Bradenton, Florida, 34208, United States
Viking Clinical Site 150, Lakewood Rch, Florida, 34211, United States
Viking Clinical Site 106, Miami, Florida, 33014, United States
Viking Clinical Site 301, Miami, Florida, 33136, United States
Viking Clinical Site 310, Miami, Florida, 33136, United States
Viking Clinical Site 221, Miami Lakes, Florida, 33016, United States
Viking Clinical Site 131, Pensacola, Florida, 32503, United States
Viking Clinical Site 215, Port Orange, Florida, 32127, United States
Viking Clinical Site 218, Sarasota, Florida, 34240, United States

Georgia

Viking Clinical Site 144, Atlanta, Georgia, 30309, United States
Viking Clinical Site 111, Marietta, Georgia, 30060, United States

Indiana

Viking Clinical Site 120, Indianapolis, Indiana, 46202, United States
Viking Clinical Site 130, South Bend, Indiana, 46635, United States

Iowa

Viking Clinical Site 211, West Des Moines, Iowa, 50265, United States

Kansas

Viking Clinical Site 145, Topeka, Kansas, 66606, United States

Louisiana

Viking Clinical Site 146, Marrero, Louisiana, 70072, United States
Viking Clinical Site 307, New Orleans, Louisiana, 70112, United States
Viking Clinical Site 166, West Monroe, Louisiana, 71291, United States

Maryland

Viking Clinical Site 109, Baltimore, Maryland, 21202, United States
Viking Clinical Site 107, Greenbelt, Maryland, 20770, United States

Massachusetts

Viking Clinical Site 147, Boston, Massachusetts, 02111, United States

Michigan

Viking Clinical Site 158, Ann Arbor, Michigan, 48109, United States
Viking Clinical Site 133, Detroit, Michigan, 48202, United States

Mississippi

Viking Clinical Site 213, Jackson, Mississippi, 39216, United States

Missouri

Viking Clinical Site 112, Kansas City, Missouri, 64111, United States
Viking Clinical Site 217, Kansas City, Missouri, 64131, United States

Nevada

Viking Clinical Site 160, Las Vegas, Nevada, 89106, United States
Viking Clinical Site 223, Reno, Nevada, 89511, United States

New York

Viking Clinical Site 152, New York, New York, 10033, United States
Viking Clinical Site 128, Rochester, New York, 14642, United States

North Carolina

Viking Clinical Site 314, Chapel Hill, North Carolina, 27514, United States
Viking Clinical Site 126, Concord, North Carolina, 28027, United States
Viking Clinical Site 116, Durham, North Carolina, 27710, United States
Viking Clinical Site 153, Morehead City, North Carolina, 28557, United States

Ohio

Viking Clinical Site 137, Cincinnati, Ohio, 45249, United States

Pennsylvania

Viking Clinical Site 148, Philadelphia, Pennsylvania, 19107, United States
Viking Clinical Site 311, Pittsburgh, Pennsylvania, 15213, United States

South Carolina

Viking Clinical Site 127, Greenville, South Carolina, 29605, United States

Tennessee

Viking Clinical Site 227, Clarksville, Tennessee, 37040, United States
Viking Clinical Site 118, Hermitage, Tennessee, 37076, United States

Texas

Viking Clinical Site 115, Arlington, Texas, 76012, United States
Viking Clinical Site 113, Dallas, Texas, 75203, United States
Viking Clinical Site 220, Edinburg, Texas, 78539, United States
Viking Clinical Site 142, Houston, Texas, 77030, United States
Viking Clinical Site 102, San Antonio, Texas, 78215, United States
Viking Clinical Site 101, San Antonio, Texas, 78229, United States
Viking Clinical Site 143, San Antonio, Texas, 78229, United States
Viking Clinical Site 201, San Antonio, Texas, 78229, United States

Utah

Viking Clinical Site 224, Ogden, Utah, 84405, United States

Virginia

Viking Clinical Site 304, Newport News, Virginia, 23602, United States
Viking Clinical Site 209, Richmond, Virginia, 23249, United States
Viking Clinical Site 312, Richmond, Virginia, 23298, United States

Washington

Viking Clinical Site 317, Seattle, Washington, 98105, United States

VBR

Viking Clinical Site 503, Brussels, VBR, 3000, Belgium
Viking Clinical Site 502, Brussels, 1070, Belgium
Viking Clinical Site 611, Amiens, 80054, France
Viking Clinical Site 612, Créteil, 94000, France
Viking Clinical Site 610, Grenoble, 38700, France
Viking Clinical Site 607, Paris, 75012, France
Viking Clinical Site 603, Paris, 75013, France

Guerrero

Viking Clinical Site 401, Acapulco de Juárez, Guerrero, 39670, Mexico

Nuevo León

Viking Clinical Site 422, Monterrey, Nuevo León, 64000, Mexico
Viking Clinical Site 421, Mexico City, 06700, Mexico
Viking Clinical Site 219, San Juan, 00927, Puerto Rico