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VK2735 for Weight Management Phase 2 (Venture Oral Dosing) Phase 2 280 Randomisiert Doppelblind Placebo-kontrolliert

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Die klinische Studie NCT06828055 untersuchte Behandlung im Zusammenhang mit Gewichtsverlust. Diese interventionsstudie der Phase 2 hat den Status abgeschlossen. Die Studie begann am 18. Dezember 2024 mit 280 Teilnehmern. Sie wurde durchgeführt von Viking Therapeutics und am 15. August 2025 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 6. Oktober 2025 aktualisiert.
Kurzbeschreibung
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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Offizieller Titel

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

Erkrankungen
Gewichtsverlust
Weitere Studien-IDs
  • VK2735-202
NCT-Nummer
NCT06828055
Studienbeginn (tatsächlich)
2024-12-18
Zuletzt aktualisiert
2025-10-06
Studienende (vorauss.)
2025-08-15
Geplante Rekrutierung
280
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Abgeschlossen
Stichwörter
Overweight Obese
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Dreifach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Placebo-VergleichspräparatPlacebo Assignment
VK2735 (Placebo) administered Daily
PLACEBO
Matching Placebo to VK2735
ExperimentellActive Assignment (Dose #1)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
ExperimentellActive Assignment (Dose #2)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
ExperimentellActive Assignment (Dose #3)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
ExperimentellActive Assignment (Dose #4)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
ExperimentellActive Assignment (Dose #5)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
ExperimentellActive Assignment (Dose #6)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle

  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
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15 Studienstandorte in 1 Ländern

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