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VK2735 for Weight Management Phase 3 (VANQUISH 1) 第III相・フェーズ3 4,500 無作為化 二重盲検 プラセボ対照

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治験番号 NCT07104500 (VANQUISH 1) は 体重減少 に関する 治療 の研究で、第III相・フェーズ3 介入研究 臨床試験 です。現在は 実施中／登録終了 で、2025年6月23日 から開始しています。4,500 名の参加者 の募集が計画されています。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、2027年8月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月24日 です。
概要
This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.
公式タイトル

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants Without Type 2 Diabetes 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
  • VANQUISH 1
  • VK2735-301
NCT番号
NCT07104500
開始日
2025-06-23
最終更新日
2025-11-24
終了予定日
2027-08-01
目標参加者数
4,500
試験の種類
介入研究
治験の相・段階
第III相・フェーズ3
状況
実施中／登録終了
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 Comparator Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
実験的Active Assignment (Dose 1)
VK2735 7.5mg Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
実験的Active Assignment (Dose 2)
VK2735 12.5mg Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
実験的Active Assignment (Dose 3)
VK2735 17.5mg Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
主要評価項目
評価指標指標の説明時間枠
Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment
78 Weeks
副次評価項目
評価指標指標の説明時間枠
Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment
78 Weeks
参加アシスタント
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)

    • Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
    • Cardiovascular disease includes, for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure
    • BMI calculated at the Screening visit will be used to determine eligibility

  1. History of or current clinically significant medical 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. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
  4. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (such as, mucosa ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
  5. Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes)
  6. Treatment with glucose-lowering agent(s) within 90 days before screening
  7. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  8. History of acute or chronic pancreatitis
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