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O estudo clínico NCT06828055 para Perda de peso 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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VK2735 for Weight Management Phase 2 (Venture Oral Dosing) Fase II 280 Randomizado Duplo-cego Controlado por placebo

Concluído
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06828055 avaliou tratamento para Perda de peso. Foi um estudo intervencionista de Fase II. Seu status atual é: concluído. O estudo iniciou em 18 de dezembro de 2024 e incluiu 280 participantes. Coordenado por Viking Therapeutics e foi concluído em 15 de agosto de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 6 de outubro de 2025.
Resumo
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

Condições médicas
Perda de peso
Outros IDs do estudo
  • VK2735-202
Número NCT
NCT06828055
Data de início (real)
2024-12-18
Última atualização postada
2025-10-06
Data de conclusão (estimada)
2025-08-15
Inscrição (estimada)
280
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Concluído
Palavras-chave
Overweight Obese
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Triplo-cego
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
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
Sem dados de contato.
15 Locais do estudo em 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