Trial Radar IA | ||
|---|---|---|
Lo studio clinico NCT06068946 (VENTURE) per Perdita di peso è completato. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
Torna alla ricerca
Viking TherapeuticsVK2735 for Weight Management Phase 2 (VENTURE) Fase II 176 Randomizzato Doppio cieco Controllato con placebo
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06068946 (VENTURE) è stata uno studio interventistico di Fase II condotto per esaminare il trattamento per Perdita di peso, attualmente completato. Avviato il 31 agosto 2023, ha previsto l'arruolamento di 176 partecipanti. Sotto la guida di Viking Therapeutics, si è concluso il 2 aprile 2024. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 12 febbraio 2025.
Sommario breve
This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 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 administered once weekly.
Titolo ufficiale
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Study of VK2735 for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition
Patologie
Perdita di pesoPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- VENTURE
- VK2735-201
Numero NCT
Data di inizio (effettiva)
2023-08-31
Ultimo aggiornamento pubblicato
2025-02-12
Data di completamento (stimata)
2024-04-02
Arruolamento (previsto)
176
Tipo di studio
Interventistico
FASE
Fase II
Stato
Completato
Parole chiave
Overweight
Obese
Obese
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore placeboVK2735 (Placebo) Placebo | PLACEBO Placebo comparator |
SperimentaleVK2735 (Dose #1) VK2735 is a peptide GLP-1 and GIP dual agonist | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist |
SperimentaleVK2735 (Dose #2) VK2735 is a peptide GLP-1 and GIP dual agonist | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist |
SperimentaleVK2735 (Dose #3) VK2735 is a peptide GLP-1 and GIP dual agonist | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist |
SperimentaleVK2735 (Dose #4) VK2735 is a peptide GLP-1 and GIP dual agonist | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Percent (relative) change from baseline to Week 13 in body weight | To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition | 13 weeks |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13 | To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition | 13 weeks |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Age ≥18 years of age at the time of signing the informed consent
- 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
- History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation
- Self-reported body weight change of 5% or more within 3 months of screening
- Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
- Current or past diagnosis of chronic pancreatitis
- Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
- Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
- Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
Viking TherapeuticsNessun dato di contatto
20 Centri dello studio in 1 paesi
Alabama
Viking Clinical Site #119, Birmingham, Alabama, 35235, United States
California
Viking Clinical Site #114, Long Beach, California, 90815, United States
Viking Clinical Site #110, Los Angeles, California, 90057, United States
Viking Clinical Site #113, Tustin, California, 92780, United States
Florida
Viking Clinical Site #116, Clearwater, Florida, 33756, United States
Viking Clinical Site #106, Clearwater, Florida, 33761, United States
Viking Clinical Site #112, Jacksonville, Florida, 32216, United States
Viking Clinical Site #105, Ocoee, Florida, 34761, United States
Viking Clinical Site #107, Port Orange, Florida, 32127, United States
Indiana
Viking Clinical Site #104, Indianapolis, Indiana, 46260, United States
Kentucky
Viking Clinical Site #103, Louisville, Kentucky, 40213, United States
Louisiana
Viking Clinical Site #109, Marrero, Louisiana, 70072, United States
Missouri
Viking Clinical Site #102, Kansas City, Missouri, 64131, United States
Montana
Viking Clinical Site #111, Butte, Montana, 59701, United States
Tennessee
Viking Clinical Site #108, Knoxville, Tennessee, 37920, United States
Texas
Viking Clinical Site #101, Austin, Texas, 78705, United States
Viking Clinical Site #118, Austin, Texas, 78731, United States
Viking Clinical Site #100, Phoenix, Texas, 85210, United States
Viking Clinical Site #115, San Antonio, Texas, 78229, United States
Viking Clinical Site #117, San Antonio, Texas, 78229, United States