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El ensayo clínico NCT07104500 (VANQUISH 1) para Pérdida de peso está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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VK2735 for Weight Management Phase 3 (VANQUISH 1) Fase III 4500 Aleatorizado Doble ciego Controlado con placebo

Activo, no reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07104500 (VANQUISH 1) está diseñado para estudiar el tratamiento de Pérdida de peso. Es un estudio intervencionista de Fase III. Su estado actual es: activo, no reclutando. El estudio se inició el 23 de junio de 2025, con el objetivo de reclutar a 4500 participantes. Dirigido por Viking Therapeutics, se espera que finalice el 1 de agosto de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 24 de noviembre de 2025.
Resumen
This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.
Título oficial

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants Without Type 2 Diabetes Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

Condiciones médicas
Pérdida de peso
Otros ID del estudio
  • VANQUISH 1
  • VK2735-301
Número del NCT
Inicio del estudio (real)
2025-06-23
Última actualización
2025-11-24
Fecha de finalización (estimada)
2027-08-01
Inscripción (prevista)
4500
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Activo, no reclutando
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Triple ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Comparador placeboPlacebo Assignment
VK2735 Placebo Comparator Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
ExperimentalActive Assignment (Dose 1)
VK2735 7.5mg Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
ExperimentalActive Assignment (Dose 2)
VK2735 12.5mg Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
ExperimentalActive Assignment (Dose 3)
VK2735 17.5mg Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment
78 Weeks
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment
78 Weeks
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  1. Age ≥18 years of age at the time of signing the informed consent

  2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co- morbid condition (treated or untreated)

    • Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
    • Cardiovascular disease includes, for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure
    • BMI calculated at the Screening visit will be used to determine eligibility

  1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
  2. Self-reported body weight change of 5% or more within 3 months of screening
  3. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
  4. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (such as, mucosa ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
  5. Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes)
  6. Treatment with glucose-lowering agent(s) within 90 days before screening
  7. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  8. History of acute or chronic pancreatitis
Viking Therapeutics, Inc. logoViking Therapeutics
No hay datos de contacto.
137 Centros del estudio en 2 países
Viking Clinical Site #1130, Mayagüez, 00680, Puerto Rico
Viking Clinical Site #1086, San Juan, 00927, Puerto Rico

Alabama

Viking Clinical Site #1037, Birmingham, Alabama, 35235, United States
Viking Clinical Site #1064, Birmingham, Alabama, 35249, United States
Viking Clinical Site #1128, Huntsville, Alabama, 35801, United States
Viking Clinical Site #1081, Mobile, Alabama, 36608, United States

Arizona

Viking Clinical Site #1005, Chandler, Arizona, 85210, United States
Viking Clinical Site #1017, Flagstaff, Arizona, 86001, United States
Viking Clinical Site #1018, Peoria, Arizona, 85381, United States
Viking Clinical Site #1135, Scottsdale, Arizona, 85260, United States
Viking Clinical Site #1019, Tucson, Arizona, 85711, United States

Arkansas

Viking Clinical Site #1036, Little Rock, Arkansas, 72211, United States

California

Viking Clinical Site #1071, Chula Vista, California, 91911, United States
Viking Clinical Site #1070, Escondido, California, 92025, United States
Viking Clinical Site #1054, Huntington Park, California, 90255, United States
Viking Clinical Site #1014, Lake Forest, California, 92630, United States
Viking Clinical Site #1129, Lemon Grove, California, 91945, United States
Viking Clinical Site #1051, Lincoln, California, 95648, United States
Viking Clinical Site #1050, Long Beach, California, 90815, United States
Viking Clinical Site #1055, Los Angeles, California, 90057, United States
Viking Clinical Site #1078, Manteca, California, 95336, United States
Viking Clinical Site #1053, Montclair, California, 91763, United States
Viking Clinical Site #1068, Panorama City, California, 91402, United States
Viking Clinical Site #1132, Rolling Hills Estates, California, 90274, United States
Viking Clinical Site #1131, San Diego, California, 92103, United States
Viking Clinical Site #1104, Santa Maria, California, 93458, United States
Viking Clinical Site #1052, Spring Valley, California, 91978, United States
Viking Clinical Site #1109, Tustin, California, 92780, United States
Viking Clinical Site #1067, Van Nuys, California, 91405, United States
Viking Clinical Site #1079, Walnut Creek, California, 94598, United States

Colorado

Viking Clinical Site #1119, Denver, Colorado, 80210, United States

District of Columbia

Viking Clinical Site #1123, Washington D.C., District of Columbia, 20036, United States

Florida

Viking Clinical Site #1013, Clearwater, Florida, 33756, United States
Viking Clinical Site #1121, Clearwater, Florida, 33761, United States
Viking Clinical Site #1003, Cooper City, Florida, 33024, United States
Viking Clinical Site #1112, DeLand, Florida, 32720, United States
Viking Clinical Site #1107, Delray Beach, Florida, 33445, United States
Viking Clinical Site #1083, Fort Myers, Florida, 33912, United States
Viking Clinical Site #1058, Jacksonville, Florida, 32216, United States
Viking Clinical Site #1076, Lakeland, Florida, 33803, United States
Viking Clinical Site #1060, Lakewood Rch, Florida, 34211, United States
Viking Clinical Site #1117, Miami, Florida, 33122, United States
Viking Clinical Site #1059, New Port Richey, Florida, 34652, United States
Viking Clinical Site #1012, Ocoee, Florida, 34761, United States
Viking Clinical Site #1056, Palmetto Bay, Florida, 33157, United States
Viking Clinical Site #1011, Port Orange, Florida, 32127, United States
Viking Clinical Site #1057, West Palm Beach, Florida, 33407, United States

Georgia

Viking Clinical Site #1116, Atlanta, Georgia, 30329, United States
Viking Clinical Site #1030, Columbus, Georgia, 31904, United States
Viking Clinical Site #1120, Rincon, Georgia, 31326, United States
Viking Clinical Site #1093, Savannah, Georgia, 31406, United States
Viking Clinical Site #1025, Woodstock, Georgia, 30189, United States

Hawaii

Viking Clinical Site #1062, Honolulu, Hawaii, 96814, United States

Idaho

Viking Clinical Site #1080, Meridian, Idaho, 83642, United States

Illinois

Viking Clinical Site #1006, Chicago, Illinois, 60607, United States
Viking Clinical Site #1090, Chicago, Illinois, 60640, United States
Viking Clinical Site #1138, Westmont, Illinois, 60559, United States

Indiana

Viking Clinical Site #1127, Valparaiso, Indiana, 46383, United States

Iowa

Viking Clinical Site #1022, West Des Moines, Iowa, 50266, United States

Kansas

Viking Clinical Site #1099, Wichita, Kansas, 67207, United States

Kentucky

Viking Clinical Site #1069, Lexington, Kentucky, 40509, United States
Viking Clinical Site #1040, Lexington, Kentucky, 40513, United States
Viking Clinical Site #1009, Louisville, Kentucky, 40213, United States

Louisiana

Viking Clinical Site #1118, Baton Rouge, Louisiana, 70808, United States
Viking Clinical Site #1139, Baton Rouge, Louisiana, 70809, United States
Viking Clinical Site #1106, Lafayette, Louisiana, 70508, United States
Viking Clinical Site #1020, Metairie, Louisiana, 70006, United States
Viking Clinical Site #1087, Monroe, Louisiana, 71201, United States

Maryland

Viking Clinical Site #1094, Chevy Chase, Maryland, 20815, United States
Viking Clinical Site #1066, Rockville, Maryland, 20854, United States

Massachusetts

Viking Clinical Site #1103, Boston, Massachusetts, 02114, United States
Viking Clinical Site #1001, Methuen, Massachusetts, 01844, United States
Viking Clinical Site #1136, Needham, Massachusetts, 02492, United States

Michigan

Viking Clinical Site #1038, Ypsilanti, Michigan, 48197, United States

Mississippi

Viking Clinical Site #1140, Gulfport, Mississippi, 39503, United States

Missouri

Viking Clinical Site #1031, City of Saint Peters, Missouri, 63303, United States
Viking Clinical Site #1016, Kansas City, Missouri, 64131, United States
Viking Clinical Site #1125, Springfield, Missouri, 65807, United States
Viking Clinical Site #1108, St Louis, Missouri, 63108, United States

Montana

Viking Clinical Site #1010, Butte, Montana, 59701, United States

Nebraska

Viking Clinical Site #1075, Omaha, Nebraska, 68134, United States

Nevada

Viking Clinical Site #1035, Las Vegas, Nevada, 89148, United States
Viking Clinical Site #1034, Reno, Nevada, 89511, United States

New Hampshire

Viking Clinical Site #1065, Lebanon, New Hampshire, 03756, United States

New Jersey

Viking Clinical Site #1095, Marlton, New Jersey, 08009, United States

New Mexico

Viking Clinical Site #1029, Albuquerque, New Mexico, 87109, United States

New York

Viking Clinical Site #1088, Albany, New York, 12205, United States
Viking Clinical Site #1042, East Syracuse, New York, 13057, United States
Viking Clinical Site #1096, Hartsdale, New York, 10530, United States
Viking Clinical Site #1133, New York, New York, 10036, United States
Viking Clinical Site #1142, New York, New York, 10065, United States
Viking Clinical Site #1021, The Bronx, New York, 10455, United States
Viking Clinical Site #1032, Westfield, New York, 14787, United States

North Carolina

Viking Clinical Site #1141, Charlotte, North Carolina, 28250, United States
Viking Clinical Site #1122, Durham, North Carolina, 27701, United States
Viking Clinical Site #1144, Fayetteville, North Carolina, 28304, United States
Viking Clinical Site #1026, Greensboro, North Carolina, 27410, United States
Viking Clinical Site #1110, Morehead City, North Carolina, 28557, United States
Viking Clinical Site #1061, Morehead City, North Carolina, 28857, United States

North Dakota

Viking Clinical Site #1027, Fargo, North Dakota, 58104, United States

Ohio

Viking Clinical Site #1043, Cincinnati, Ohio, 45219, United States
Viking Clinical Site #1074, Cincinnati, Ohio, 45242, United States
Viking Clinical Site #1044, Cleveland, Ohio, 44122, United States
Viking Clinical Site #1089, Columbus, Ohio, 43215, United States

Oklahoma

Viking Clinical Site #1113, Norman, Oklahoma, 73069, United States
Viking Clinical Site #1137, Tulsa, Oklahoma, 74133, United States

Oregon

Viking Clinical Site #1102, Medford, Oregon, 97504, United States
Viking Clinical Site #1097, Portland, Oregon, 97202, United States
Viking Clinical Site #1126, Portland, Oregon, 97210, United States

Rhode Island

Viking Clinical Site #1045, East Greenwich, Rhode Island, 02818, United States

South Carolina

Viking Clinical Site #1028, Greenville, South Carolina, 29607, United States
Viking Clinical Site #1134, Myrtle Beach, South Carolina, 29572, United States
Viking Clinical Site #1023, North Charleston, South Carolina, 29405, United States

Tennessee

Viking Clinical Site #1004, Knoxville, Tennessee, 37909, United States
Viking Clinical Site #1008, Nashville, Tennessee, 37203, United States

Texas

Viking Clinical Site #1047, Abilene, Texas, 79606, United States
Viking Clinical Site #1063, Austin, Texas, 78131, United States
Viking Clinical Site #1007, Austin, Texas, 78705, United States
Viking Clinical Site #1091, Bellaire, Texas, 77401, United States
Viking Clinical Site #1124, Brownsville, Texas, 78526, United States
Viking Clinical Site #1049, Dallas, Texas, 75230, United States
Viking Clinical Site #1048, Dallas, Texas, 75235, United States
Viking Clinical Site #1111, Frisco, Texas, 75033, United States
Viking Clinical Site #1046, Houston, Texas, 77040, United States
Viking Clinical Site #1077, Lampasas, Texas, 76550, United States
Viking Clinical Site #1143, San Antonio, Texas, 78215, United States
Viking Clinical Site #1085, San Antonio, Texas, 78222, United States
Viking Clinical Site #1073, San Antonio, Texas, 78229, United States
Viking Clinical Site #1101, Waco, Texas, 76710, United States

Utah

Viking Clinical Site #1002, Ogden, Utah, 84405, United States
Viking Clinical Site #1092, Salt Lake City, Utah, 84107, United States
Viking Clinical Site #1039, Sandy City, Utah, 84094, United States
Viking Clinical Site #1024, St. George, Utah, 84790, United States

Virginia

Viking Clinical Site #1098, Arlington, Virginia, 22205, United States
Viking Clinical Site #1082, Suffolk, Virginia, 23435, United States

Washington

Viking Clinical Site #1072, Renton, Washington, 98057, United States
Viking Clinical Site #1041, Spokane, Washington, 99218, United States