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VK2735 for Weight Management Phase 2 (Venture Oral Dosing) Fase II 280 Aleatorizado Doble ciego Controlado con placebo

Completado
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 NCT06828055 tuvo como objetivo estudiar el tratamiento de Pérdida de peso. Este fue un estudio intervencionista de Fase II. Su estado actual es: completado. El estudio se inició el 18 de diciembre de 2024, con el objetivo de reclutar a 280 participantes. Dirigido por Viking Therapeutics, la fecha de finalización prevista fue el 15 de agosto de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 6 de octubre de 2025.
Resumen
This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

VK2735 or matched placebo will be administ...

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Título oficial

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Dose Finding Study of VK2735 Oral Formulation for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

Condiciones médicas
Pérdida de peso
Otros ID del estudio
  • VK2735-202
Número del NCT
NCT06828055
Inicio del estudio (real)
2024-12-18
Última actualización
2025-10-06
Fecha de finalización (estimada)
2025-08-15
Inscripción (prevista)
280
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Completado
Palabras clave
Overweight Obese
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) administered Daily
PLACEBO
Matching Placebo to VK2735
ExperimentalActive Assignment (Dose #1)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
ExperimentalActive Assignment (Dose #2)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
ExperimentalActive Assignment (Dose #3)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
ExperimentalActive Assignment (Dose #4)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
ExperimentalActive Assignment (Dose #5)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
ExperimentalActive Assignment (Dose #6)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Percent (relative) change from baseline in body weight after 13 weeks of treatment
To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition
13 Weeks
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13. Observed and change from baseline in body weight (kg) after 13 weeks of treatment
To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition
13 Weeks
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), and BMI <50 kg/m2

    • Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.
    • BMI calculated at the Screening visit will be used to determine eligibility.

  1. History of or current clinically significant medical or psychiatric 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. Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
  4. Current or past diagnosis of chronic pancreatitis
  5. Calcitonin ≥50 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
  6. Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
  7. Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
Viking Therapeutics, Inc. logoViking Therapeutics
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15 Centros del estudio en 1 países

Arizona

Viking Clinical Site #111, Peoria, Arizona, 85381, United States

California

Viking Clinical Site #105, Lake Forest, California, 96230, United States

Florida

Viking Clinical Site #101, Clearwater, Florida, 33756, United States
Viking Clinical Site #108, Largo, Florida, 33777, United States
Viking Clinical Site #107, Ocoee, Florida, 34761, United States
Viking Clinical Site #102, Port Orange, Florida, 32127, United States

Indiana

Viking Clinical Site #100, Indianapolis, Indiana, 46260, United States

Kentucky

Viking Clinical Site #110, Louisville, Kentucky, 40213, United States

Louisiana

Viking Clinical Site #114, Marrero, Louisiana, 70072, United States

Missouri

Viking Clinical Site #109, City of Saint Peters, Missouri, 63303, United States
Viking Clinical Site #112, Kansas City, Missouri, 64131, United States

Montana

Viking Clinical Site #113, Butte, Montana, 59701, United States

Tennessee

Viking Clinical Site #103, Knoxville, Tennessee, 37909, United States

Texas

Viking Clinical Site #104, Austin, Texas, 78705, United States
Viking Clinical Site #106, San Antonio, Texas, 78229, United States