Un estudio de tirzepatida (LY3298176) en participantes con esteatohepatitis no alcoólica (NASH)

Un estudio de fase 2 aleatorizado, doble ciego y controlado con placebo que compara la eficacia y seguridad de la tirzepatida frente al placebo en pacientes con esteatohepatitis no alcohólica (NASH)

Patrocinadores

Patrocinador principal: Eli Lilly and Company

Fuente Eli Lilly and Company
Resumen breve

El propósito de este estudio es ver si el fármaco del estudio, tirzepatida administrada una vez a la semana, es seguro y eficaz como tratamiento para la esteatohepatitis no alcohólica (NASH).

Estado general Reclutamiento
Fecha de inicio 2019-11-19
Fecha de Terminación 2022-06-22
Fecha de finalización primaria 2022-06-22
Fase Fase 2
Tipo de estudio Intervencionista
Resultado primario
Medida Periodo de tiempo
Porcentaje de participantes con ausencia de EHNA sin empeoramiento de la fibrosis en la histología hepática Semana 52
Resultado secundario
Medida Periodo de tiempo
Percentage of Participants with ≥1 Point Decrease in Fibrosis Stage with No Worsening of NASH on Liver Histology Week 52
Porcentaje de participantes con un aumento de ≥1 punto en el estadio de fibrosis en la histología hepática Semana 52
Porcentaje de participantes que logran una disminución de ≥2 puntos en la puntuación de actividad (NAS) de NAFLD (enfermedad del hígado graso no alcohólico) en la histología hepática, con una reducción de ≥1 punto en al menos 2 componentes de NAS Semana 52
Cambio absoluto medio desde el valor inicial en el contenido de grasa hepática mediante imágenes de resonancia magnética - Fracción de grasa de densidad de protones (MRI-PDFF) Línea de base, semana 52
Cambio medio con respecto al valor inicial en el peso corporal Línea de base, semana 52
Inscripción 196
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Tirzepatide

Descripción: Administered SC

Otro nombre: LY3298176

Tipo de intervención: Droga

Nombre de intervención: Placebo

Descripción: SC administrado

Etiqueta de grupo de brazo: Placebo

Elegibilidad

Criterios:

- Los participantes deben tener un índice de masa corporal (IMC) ≥27 kilogramos por metro cuadrado (kg / m²) y ≤50 kg / m² con peso corporal estable durante al menos 3 meses - Participantes con o sin diabetes mellitus tipo 2 (DM2) - Si tiene DM2, hemoglobina A1c (HbA1c) ≤9,5% - Los participantes deben estar dispuestos a someterse a biopsias hepáticas iniciales y finales. - Los participantes deben tener un diagnóstico histológico de EHNA con fibrosis en estadio 2 o 3 mediante biopsia hepatica - Los participantes no deben tener conocimiento o sospecha de abuso de alcohol (> 14 unidades / semana para mujeres y> 21 unidades / semana para hombres) o abuso de sustancias activas - Los participantes no deben tener evidencia de cirrosis u otras formas de enfermedad hepática. - Los participantes no deben tener un ataque cardíaco, accidente cerebrovascular u hospitalización por congestión. insuficiencia cardíaca en los últimos 6 meses - Los participantes no deben tener cáncer activo en los últimos 5 años. - Los participantes no deben tener presión arterial alta no controlada. - Los participantes no deben tener insuficiencia renal con tasa de filtración glomerular estimada. (eGFR)

Género:

Todas

Edad mínima:

18 años

Edad máxima:

80 años

Voluntarios Saludables:

No

Oficial general
Apellido Papel Afiliación
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company
Contacto general

Apellido: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Teléfono: 1-317-615-4559

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador:
University of Alabama at Birmingham Medical Center | Birmingham, Alabama, 35233, United States Recruiting 205-975-5683 Meagan Gray Principal Investigator
Synexus- Chandler | Chandler, Arizona, 85224, United States Recruiting 480-775-1115 Donna M DeSantis Principal Investigator
Fresno Clinical Research Center | Fresno, California, 93720, United States Recruiting 559-297-2259 Muhammad Sheikh Principal Investigator
National Research Institute - Huntington Park | Huntington Park, California, 90255, United States Recruiting 323-588-1968 Stanley H. Hsia Principal Investigator
National Research Institute - Huntington Park | Huntington Park, California, 90255, United States Recruiting 2134132500 Juan Pablo Frias Principal Investigator
NAFLD Research Center, UCSD Altman Clinical and Translational Research Institute (ACTRI) | La Jolla, California, 92037, United States Recruiting 858-246-2201 Rohit Loomba Principal Investigator
Catalina Research Institute, LLC | Montclair, California, 91763, United States Recruiting 909-590-8409 Rizwana H Mohseni Principal Investigator
Diabetes Medical Center of California | Northridge, California, 91325, United States Recruiting 818-368-4212 Gholamreza Bonabi Principal Investigator
National Research Institute - Huntington Park | Panorama City, California, 91402, United States Recruiting 8185326880 Robert Allen Jenders Principal Investigator
Alliance Clinical Research, LLC | Poway, California, 90264, United States Recruiting 949-973-3704 Kevin Merkes Principal Investigator
Inland Empire Liver Foundation | Rialto, California, 92377, United States Recruiting 909-883-2999 Zeid Kayali Principal Investigator
National Research Institute - Huntington Park | Santa Ana, California, 92704, United States Recruiting 714-599-8711 Mark T. Leibowitz Principal Investigator
Excel Medical Clinical Trials | Boca Raton, Florida, 33434, United States Recruiting 561-488-5535 Seth J. Baum Principal Investigator
Clinical Research of South Florida | Coral Gables, Florida, 33134, United States Recruiting 3054455637 Jeffrey Bruce Rosen Principal Investigator
North Florida South Georgia Veterans Health System | Gainesville, Florida, 32608, United States Recruiting 352-376-1611 Kenneth Cusi Principal Investigator
Research Centers of America, LLC-Hollywood | Hollywood, Florida, 33024, United States Recruiting 954-919-7809 HOWARD SCHWARTZ Principal Investigator
East Coast Institute for Research at The Jones Center | Jacksonville, Florida, 32204, United States Recruiting 9043842240 James Sample Magee Principal Investigator
I.H.S. Health, LLC | Kissimmee, Florida, 34741, United States Not yet recruiting 407-530-4370 Syed Lateef Principal Investigator
Meridien Research | Maitland, Florida, 32751, United States Recruiting 407-644-1165 Eva Maria Heurich Principal Investigator
Panax Clinical Research | Miami Lakes, Florida, 33014, United States Not yet recruiting 305-698-4500 Robert Perry Principal Investigator
Clinical Pharmacology of Miami | Miami, Florida, 33014, United States Recruiting 305-817-2900 Ernesto Fuentes Principal Investigator
Endoscopic Research Inc | Orlando, Florida, 32803, United States Recruiting 407-241-3229 Henry Levine Principal Investigator
Synexus Clinical Research US, Inc - Orlando | Orlando, Florida, 32806, United States Recruiting 407-426-9299 Judith L. White Principal Investigator
Synexus Clinical Research US, Inc. | The Villages, Florida, 32162, United States Recruiting 3522610901 Jewel Johnny White Principal Investigator
AES/Synexus - Atlanta | Atlanta, Georgia, 30328, United States Recruiting 404-255-6005 Sherif Naguib Principal Investigator
Humphreys Diabetes Center | Boise, Idaho, 83702, United States Not yet recruiting 208-287-9429 Sherwin D'Souza Principal Investigator
Synexus Clinical Research | Chicago, Illinois, 60602, United States Recruiting 312-494-2227 Laura M Pearlman Principal Investigator
Northwestern Feinberg School of Medicine | Chicago, Illinois, 60611, United States Recruiting 312-695-5878 Mary Rinella Principal Investigator
Indiana University Health Hospital | Indianapolis, Indiana, 46202, United States Recruiting 317-278-6200 Raj K Vuppalanchi Principal Investigator
Iowa Diabetes and Endocrinology Research Center | West Des Moines, Iowa, 50265, United States Recruiting 515-329-6800 Anuj Bhargava Principal Investigator
Heartland Research Associates | Newton, Kansas, 67114, United States Recruiting 316-689-6629 Richard M Glover Principal Investigator
Cotton O'Neil Diabetes and Endocrinology Center | Topeka, Kansas, 66606, United States Recruiting 785-368-0482 susan brian Principal Investigator
Heartland Research Associates | Wichita, Kansas, 67207, United States Recruiting 316-689-6629 Thomas C. Klein Principal Investigator
Tandem Clinical Research,LLC | Marrero, Louisiana, 70072, United States Recruiting 504-934-8424 Gary Reiss Principal Investigator
Victory Clinical Research | Greenbelt, Maryland, 20770, United States Not yet recruiting 301-441-1704 Kolapo Idowu Principal Investigator
The National Diabetes & Obesity Research Institute (NDORI) | Biloxi, Mississippi, 39532, United States Recruiting 228-831-8764 Mark Borchelt Principal Investigator
Southern Therapy and Advanced Research (STAR) LLC | Jackson, Mississippi, 39216, United States Recruiting 769-251-5674 Brian Borg Principal Investigator
Montefiore Medical Center | Bronx, New York, 10467-2490, United States Recruiting 718-920-4664 Samuel Sigal Principal Investigator
University at Buffalo-Clinical and Translational Research Center | Buffalo, New York, 14203-1070, United States Recruiting 716-888-4737 Andrew Talal Principal Investigator
NYU Langone Medical Center | New York, New York, 10016, United States Recruiting 646-501-4927 Ira Jacobson Principal Investigator
Mount Sinai School of Medicine | New York, New York, 10029-6574, United States Not yet recruiting 212-241-7270 Amreen Dinani Principal Investigator
Diabetes & Endocrinology Consultants, PC | Morehead City, North Carolina, 28557, United States Recruiting 2522225700 x25 Kathryn Jean Lucas Principal Investigator
Geisinger Clinic | Danville, Pennsylvania, 17822, United States Not yet recruiting 570-214-2215 Christopher Still Principal Investigator
WR-Clinsearch, LLC | Chattanooga, Tennessee, 37421, United States Recruiting 423-698-4584 Mark McKenzie Principal Investigator
Texas Diabetes & Endocrinology, P.A. | Austin, Texas, 78749, United States Recruiting 512-458-8400 Tira Chaicha- Brom Principal Investigator
Dallas Diabetes Research Center | Dallas, Texas, 75230, United States Recruiting 972-566-8631 Julio Rosenstock Principal Investigator
Liver Center of Texas, PLLC | Dallas, Texas, 75234-7858, United States Recruiting 469-317-7703 Abdullah Mubarak Principal Investigator
Synexus - Dallas | Dallas, Texas, 75234, United States Recruiting 972-241-1222 Michele D. Reynolds Principal Investigator
Soma Clinical Trials, LLC | Denison, Texas, 75020, United States Not yet recruiting 940-594-9942 Hesham Elgouhari Principal Investigator
The Texas Liver Institute | San Antonio, Texas, 78215, United States Recruiting 210-253-3426 Eric J. Lawitz Principal Investigator
Endeavor Clinical Trials | San Antonio, Texas, 78229, United States Recruiting 2109490807 Hernan Alfonso Salazar Principal Investigator
Synexus - San Antonio | San Antonio, Texas, 78229, United States Recruiting 210-614-7483 William P. Jennings Principal Investigator
National Clinical Research, Inc | Richmond, Virginia, 23294, United States Recruiting 8046722295 John Keith Scott Principal Investigator
Virginia Commonwealth University Medical Center Gastroenterology Hepatology | Richmond, Virginia, 23298, United States Recruiting 804-920-0717 Mohammad S Siddiqui Principal Investigator
Harborview Medical Center/University of Washington | Seattle, Washington, 98104, United States Recruiting 206-744-7064 Charles Landis Principal Investigator
UZ Gent Hospital | Gent, East Flanders, 9000, Belgium Recruiting 003293322374 Anja Geerts Principal Investigator
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven, Flemish Brabant, 3000, Belgium Recruiting 003216346994 Ann Mertens Principal Investigator
AZ Delta | Roeselare, West Flanders, 8800, Belgium Recruiting 003251237534 Charlotte De Vloo Principal Investigator
UZ Brussel | Brussel, 1090, Belgium Recruiting 003224777760 Hendrik Reynaert Principal Investigator
Universitair Ziekenhuis Antwerpen | Edegem, 2650, Belgium Recruiting 0032382134780 Christophe De Block Principal Investigator
Hôpital Saint Antoine - Service d'Hépato-gastro-entérologie | Paris, Cedex 12, 75012, France Recruiting 0033149283398 Marie Lequoy Principal Investigator
CHU Angers | Angers, Cedex 9, 49933, France Recruiting 0033241353410 Jerome Boursier Principal Investigator
CHU Rangueil | Toulouse, Cedex, 31059, France Recruiting 0033561772263 Christophe Bureau Principal Investigator
CHRU de Limoges Hopital Dupuytren | Limoges CEDEX, 87042, France Recruiting 0033555056641 Véronique LOUSTAUD-RATTI Principal Investigator
Hôpital Pitié-Salpêtrière - IM2A | Paris, 75013, France Recruiting 0033184827762 Vlad Ratziu Principal Investigator
Chu Haut-Leveque | Pessac, 33604, France Recruiting 0033557656995 Victor De Ledinghen Principal Investigator
Centre Hospitalier Lyon Sud | Pierre Benite Cedex, 69495, France Recruiting 0033478864448 Cyrielle Caussy Principal Investigator
Groupe hospitalier mutualiste Les Portes du sud | Venissieux, 69200, France Recruiting 0033472898929 Lionel Wander Principal Investigator
Rambam Medical Center | Haifa, 3109601, Israel Recruiting 0097247772956 Ella Veitsman Principal Investigator
Shaare Zedek Medical Center | Jerusalem, 91031, Israel Recruiting 0097226555035 Yoav Lurie Principal Investigator
Hadassah Medical Center | Jerusalem, 91120, Israel Recruiting 0097226777337 Rifaat Safadi Principal Investigator
Galilee Medical Center - Internal A | Nahariya, 22100, Israel Recruiting 0097249107365 Assy Nimer Principal Investigator
Sheba Medical Center | Ramat Gan, 5265601, Israel Recruiting 0097235307180 Ziv Ben-Ari Principal Investigator
Carmel Hospital | Haifa, Ḥeifā, 3436212, Israel Not yet recruiting 0097248250053 Eli Zuckerman Principal Investigator
Azienda Ospedaliero Universitaria Ospedali Riuniti Di Foggia | Foggia, 71100, Italy Recruiting 00390881741587 Gaetano Serviddio Principal Investigator
Ospedale Santa Maria Goretti | Latina, 04100, Italy Recruiting 003907736553805 Frida Leonetti Principal Investigator
Ospedale Maggiore di Milano | Milano, 20122, Italy Recruiting 00390250320610 Emanuela Orsi Principal Investigator
A.O. Universitaria Policlinico P. Giaccone | Palermo, 90127, Italy Recruiting 00390916552145 Salvatore Petta Principal Investigator
A.O.U. Citta' della Salute e della Scienza di Torino | Torino, 10126, Italy Recruiting 0039011633541 Elisabetta Bugianesi Principal Investigator
Aichi Medical University Hospital | Nagakute-shi, Aichi-ken, 480-1195, Japan Recruiting 81120023812 Masashi Yoneda Principal Investigator
Fukui-ken Saiseikai Hospital | Wadanaka-cho, Fukui-City, Fukui, 918 8503, Japan Recruiting 81120023812 Kazuo Notsumata Principal Investigator
JCHO Hokkaido Hospital | Sapporo-shi, Hokkaido, 062-8618, Japan Recruiting 81120023812 Ken Furuya Principal Investigator
Yokohama City University Hospital | Yokohama, Kanagawa, 236-0004, Japan Recruiting 81120023812 Masato Yoneda Principal Investigator
JADECOM Nara City Hospital | Nara-Shi, Nara-Ken, 630-8305, Japan Recruiting 81120023812 Saiyu Tanaka Principal Investigator
Hirakata kohsai Hospital | Higashi-cho, Hirakata-city, Osaka, 573-0153, Japan Recruiting 81120023812 Masahiro Kido Principal Investigator
Saiseikai Suita Hospital | Suita-shi, Osaka, 5640013, Japan Recruiting 81120023812 Toshihide Shima Principal Investigator
Shimane University Hospital | Izumo, Shimane, 693-8501, Japan Recruiting 81120023812 Hiroshi Tobita Principal Investigator
Tokyo Medical And Dental University Medical Hospital | Bunkyō, Tokyo, 113-8519, Japan Recruiting 81120023812 Yasuhiro Asahina Principal Investigator
Gifu Municipal Hospital | Gifu, 500-8513, Japan Recruiting 81120023812 Hideki Hayashi Principal Investigator
Niigata University Medical & Dental Hospital | Niigata, 951-8520, Japan Recruiting 81120023812 Takeshi Yokoo Principal Investigator
Saga Medical School Hospital | Saga, 849-8501, Japan Recruiting 81120023812 Hirokazu Takahashi Principal Investigator
Grupo Medico Camino Sc | México City, Distrito Federal, 03310, Mexico Recruiting 525541689873 Jorge Rojas Serrano Principal Investigator
Phylasis Clinicas Research S de RL de CV | Cuautitlan Izcalli, Estado De Mexico, 54769, Mexico Recruiting 525558173864 Enrique Fernandez Castro Principal Investigator
Centro de Inv y Gastroenterolo | Mexico City, MX, 06700, Mexico Recruiting 525510546591 Alma Laura Ladron de Guevara Principal Investigator
Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warszawa, Mazowieckie, 01-192, Poland Not yet recruiting 0048223801062 Ewa Czernecka Principal Investigator
Synexus Polska Sp. z o.o. Oddzial w Lodzi | Lodz, 90-127, Poland Not yet recruiting 0048422986504 Agnieszka Harasiuk Principal Investigator
Hospital Universitario Marques De Valdecilla | Santander, Cantabria, 39008, Spain Recruiting 0034942202680 Javier Crespo Garcia Principal Investigator
Hospital Puerta De Hierro | Majadahonda, Madrid, 28222, Spain Recruiting 0034911917334 Jose Luis Calleja Principal Investigator
Hospital Universitario Son Espases | Palma De Mallorca, Palma De Mallorca (Baleares), 07014, Spain Recruiting 0034971175000 Santiago Tofe Povedano Principal Investigator
Instituto de Ciencias Médicas | Alicante, 03004, Spain Recruiting 0034966592350 Luis De Teresa Parreno Principal Investigator
Hospital Universitario Ramón y Cajal | Madrid, 28034, Spain Recruiting 0034913368592 Agustin Albillos Martinez Principal Investigator
Hospital Universitario Virgen Del Rocio | Sevilla, 41013, Spain Recruiting 0034955012065 Manuel Romero Gomez Principal Investigator
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) | Seville, 41003, Spain Recruiting 0034954709183 Javier García de Paso Mora Principal Investigator
Synexus Midlands Clinical Research Center | Edgbaston, Birmingham, B15 2SQ, United Kingdom Recruiting 00441214140303 Karen Faulkner Principal Investigator
Queen's Medical Centre, Nottingham University Hospitals | Nottingham, Nottinghamshire, NG7 2UH, United Kingdom Recruiting 00441159249924 Stephen Ryder Principal Investigator
John Radcliffe Hospital | Oxford, Oxfordshire, OX3 9DU, United Kingdom Recruiting 00441865228756 Jeremy Cobbold Principal Investigator
Queen Elizabeth Hospital | Birmingham, West Midlands, B15 2TH, United Kingdom Recruiting 00441213714673 Matthew Armstrong Principal Investigator
Synexus Lancashire Clinical Research Centre | Chorley, PR7 7NA, United Kingdom Recruiting 00441772819600 Carol Pretswell Principal Investigator
Synexus North East Clinical Research Centre | Hexham, NE46 1QJ, United Kingdom Recruiting 00441434604483 Shalini Iyengar Principal Investigator
Aintree University Hospital NHS Foundation Trust | Liverpool, L9 7AL, United Kingdom Recruiting 00441515292814 Cyril Sieberhagen Principal Investigator
Barts Health NHS Trust | London, E1 1FR, United Kingdom Recruiting 00442035946773 William Alazawi Principal Investigator
St. George's University Hospitals NHS Foundation Trust | London, SW17 0QT, United Kingdom Recruiting 00442082666866 Daniel Forton Principal Investigator
Imperial College London and Imperial College Healthcare NHS Trust | London, W2 1NY, United Kingdom Recruiting 00442033126666 Pinelopi Manousou Principal Investigator
Synexus Manchester Clinical Research Centre | Manchester, M15 6SE, United Kingdom Recruiting 00441616087790 Madhu Venkate Gowda Principal Investigator
Southampton General Hospital | Southampton, SO16 6YD, United Kingdom Recruiting 00442381204862 Janisha Patel Principal Investigator
Synexus North Teesside Clinical Research Centre | Stockton-on-Tees, TS19 8PE, United Kingdom Recruiting 00441642602381 Lisa Husband Principal Investigator
Ubicacion Paises

Belgium

France

Israel

Italy

Japan

Mexico

Poland

Spain

United Kingdom

United States

Fecha de verificación

2021-05-01

Fiesta responsable

Tipo: Patrocinador

Tiene acceso ampliado No
Número de brazos 4
Grupo de brazo

Etiqueta: 5 mg Tirzepatide

Tipo: Experimental

Descripción: 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

Etiqueta: 10 mg de tirzepatida

Tipo: Experimental

Descripción: 10 mg de tirzepatida administrados por vía subcutánea una vez a la semana.

Etiqueta: 15 mg de tirzepatida

Tipo: Experimental

Descripción: 15 mg de tirzepatida administrados SC una vez a la semana.

Etiqueta: Placebo

Tipo: Comparador de placebo

Descripción: Placebo administrado SC una vez a la semana.

Acrónimo SYNERGY-NASH
Información de diseño del estudio

Asignación: Aleatorizado

Modelo de intervención: Asignación paralela

Propósito primario: Tratamiento

Enmascaramiento: Doble (participante, investigador)

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