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治験 NCT06828055（対象：体重減少）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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VK2735 for Weight Management Phase 2 (Venture Oral Dosing) 第II相・フェーズ2 280 無作為化 二重盲検 プラセボ対照

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治験番号 NCT06828055 は 治療 の研究で、体重減少 を対象とした 第II相・フェーズ2 介入研究 臨床試験 でした。現在は 完了 です。2024年12月18日 に開始し、280 名の参加者 が参加しました。この試験は バイキング・セラピューティクス によって主導され、2025年8月15日 に完了しました。ClinicalTrials.gov からの最新更新日は 2025年10月6日 です。
概要
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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公式タイトル

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

疾患名
体重減少
その他の研究識別子
  • VK2735-202
NCT番号
NCT06828055
開始日
2024-12-18
最終更新日
2025-10-06
終了予定日
2025-08-15
目標参加者数
280
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
状況
完了
キーワード
Overweight Obese
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
三重盲検
群（アーム）／介入
参加グループ/群介入/治療法
プラセボ対照薬Placebo Assignment
VK2735 (Placebo) administered Daily
プラセボ
Matching Placebo to VK2735
実験的Active Assignment (Dose #1)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
実験的Active Assignment (Dose #2)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
実験的Active Assignment (Dose #3)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
実験的Active Assignment (Dose #4)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
実験的Active Assignment (Dose #5)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
実験的Active Assignment (Dose #6)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
VK2735
Active Treatment
主要評価項目
評価指標指標の説明時間枠
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
副次評価項目
評価指標指標の説明時間枠
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
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て

  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 1カ国の場所

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