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治験 NCT04173065 (VOYAGE)（対象：非アルコール性脂肪肝炎 (NASH)）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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バイキング・セラピューティクスA Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH (VOYAGE) 第II相・フェーズ2 248 二重盲検
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04173065 (VOYAGE) は 治療 の研究で、非アルコール性脂肪肝炎 (NASH) 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。2019年11月15日 に開始し、248 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、2024年1月26日 に完了しました。ClinicalTrials.gov からの最新更新日は 2024年6月14日 です。
概要
The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three hundred thirty-seven subjects will be enrolled into five treatme...もっと見る
公式タイトル
VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis
疾患名
非アルコール性脂肪肝炎 (NASH)その他の研究識別子
- VOYAGE
- VK2809-202
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
四重盲検
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 | プラセボ Capsule |
実験的1.0 mg | VK2809 Capsule |
実験的2.5mg | VK2809 Capsule |
実験的5.0 mg | VK2809 Capsule |
実験的10 mg | VK2809 Capsule |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Liver Fat | Relative change in liver fat content (assessed by MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809 compared to the change in subjects treated with placebo. | 12 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
NASH CRN fibrosis score | Proportion of subjects with resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH CRN fibrosis score. | 52 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
Provide a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study and is willing and able to participate;
Have a histologically-confirmed diagnosis of NASH on a liver biopsy performed during screening or within 6 months before screening; for this study, confirmation requires:
- NASH Clinical Research Network (CRN) fibrosis stage 1 to stage 3 and
- NASH activity score (NAS) of ≥4 with at least a score of 1 in each of the following NAS components: ballooning degeneration (score = 0-2), lobular inflammation (score = 0-3) and steatosis (score = 0-3); (c) F1 subjects must have at least one of these risk factors: type 2 diabetes, body mass index of ≥ 30 mg/ m2, and/ or alanine aminotransferase > 1.5 x ULN
Have a screening MRI-PDFF with ≥ 8% liver fat fraction;
Male and females be 18 to 75 years of age, inclusive, at screening;
- Are unwilling to undergo the required liver biopsy procedures or have any condition that would prevent obtaining a liver biopsy as part of this clinical protocol
- Have evidence of current or history of excessive alcohol consumption of more than 20 g per day for women and 30 g per day for men, on average, within 6 months before the qualifying liver biopsy and up to randomization, or are unable to provide a reliable estimate of alcohol consumption during this period;
- Treatment with medications for the purpose of weight loss within 6 months prior to qualifying liver biopsy, unless approved after consultation with the medical monitor. These include drugs approved for weight loss (e.g. orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as drugs used off-label, herbal preparations and dietary supplements marketed for control of body weight or appetite;
- TSH outside central laboratory reference range;
- Free T4 outside central laboratory reference range;
- Cardiac troponin I (cTnI) and creatine kinase MB isoenzyme (CK-MB) > Upper Limit of Normal (ULN) at screening;
- Serum albumin < 3.5 g/dL;
- International normalized ratio (INR) > 1.3;
- Total bilirubin > 1.2 X ULN (except in presence of Gilbert synd
- Strong or moderate inhibitors or inducers of CYP3A4 are prohibited during the study period
- Drugs that may affect liver fat content or are associated with nonalcoholic fatty liver disease (NAFLD) are prohibited during the 3 month period prior to the baseline liver biopsy and up to the end of treatment
バイキング・セラピューティクス連絡先情報がありません。
79 5カ国の場所
Alabama
Viking Clinical Site 105, Madison, Alabama, 35758, United States
Arizona
Viking Clinical Site 216, Glendale, Arizona, 85306, United States
Viking Clinical Site 159, Tucson, Arizona, 85712, United States
Arkansas
Viking Clinical Site 214, North Little Rock, Arkansas, 72117, United States
California
Viking Clinical Site 161, Fresno, California, 93701, United States
Viking Clinical Site 208, Fresno, California, 93720, United States
Viking Clinical Site 302, La Jolla, California, 92037, United States
Viking Clinical Site 134, Montclair, California, 91736, United States
Viking Clinical Site 205, Panorama City, California, 91402, United States
Viking Clinical Site 125, Pasadena, California, 91105, United States
Viking Clinical Site 110, Rialto, California, 92377, United States
Viking Clinical Site 117, Sacramento, California, 95817, United States
Viking Clinical Site 121, San Diego, California, 92037, United States
Viking Clinical Site 103, San Francisco, California, 94115, United States
Connecticut
Viking Clinical Site 156, New Haven, Connecticut, 06510, United States
Florida
Viking Clinical Site 226, Bradenton, Florida, 34208, United States
Viking Clinical Site 150, Lakewood Rch, Florida, 34211, United States
Viking Clinical Site 106, Miami, Florida, 33014, United States
Viking Clinical Site 301, Miami, Florida, 33136, United States
Viking Clinical Site 310, Miami, Florida, 33136, United States
Viking Clinical Site 221, Miami Lakes, Florida, 33016, United States
Viking Clinical Site 131, Pensacola, Florida, 32503, United States
Viking Clinical Site 215, Port Orange, Florida, 32127, United States
Viking Clinical Site 218, Sarasota, Florida, 34240, United States
Georgia
Viking Clinical Site 144, Atlanta, Georgia, 30309, United States
Viking Clinical Site 111, Marietta, Georgia, 30060, United States
Indiana
Viking Clinical Site 120, Indianapolis, Indiana, 46202, United States
Viking Clinical Site 130, South Bend, Indiana, 46635, United States
Iowa
Viking Clinical Site 211, West Des Moines, Iowa, 50265, United States
Kansas
Viking Clinical Site 145, Topeka, Kansas, 66606, United States
Louisiana
Viking Clinical Site 146, Marrero, Louisiana, 70072, United States
Viking Clinical Site 307, New Orleans, Louisiana, 70112, United States
Viking Clinical Site 166, West Monroe, Louisiana, 71291, United States
Maryland
Viking Clinical Site 109, Baltimore, Maryland, 21202, United States
Viking Clinical Site 107, Greenbelt, Maryland, 20770, United States
Massachusetts
Viking Clinical Site 147, Boston, Massachusetts, 02111, United States
Michigan
Viking Clinical Site 158, Ann Arbor, Michigan, 48109, United States
Viking Clinical Site 133, Detroit, Michigan, 48202, United States
Mississippi
Viking Clinical Site 213, Jackson, Mississippi, 39216, United States
Missouri
Viking Clinical Site 112, Kansas City, Missouri, 64111, United States
Viking Clinical Site 217, Kansas City, Missouri, 64131, United States
Nevada
Viking Clinical Site 160, Las Vegas, Nevada, 89106, United States
Viking Clinical Site 223, Reno, Nevada, 89511, United States
New York
Viking Clinical Site 152, New York, New York, 10033, United States
Viking Clinical Site 128, Rochester, New York, 14642, United States
North Carolina
Viking Clinical Site 314, Chapel Hill, North Carolina, 27514, United States
Viking Clinical Site 126, Concord, North Carolina, 28027, United States
Viking Clinical Site 116, Durham, North Carolina, 27710, United States
Viking Clinical Site 153, Morehead City, North Carolina, 28557, United States
Ohio
Viking Clinical Site 137, Cincinnati, Ohio, 45249, United States
Pennsylvania
Viking Clinical Site 148, Philadelphia, Pennsylvania, 19107, United States
Viking Clinical Site 311, Pittsburgh, Pennsylvania, 15213, United States
South Carolina
Viking Clinical Site 127, Greenville, South Carolina, 29605, United States
Tennessee
Viking Clinical Site 227, Clarksville, Tennessee, 37040, United States
Viking Clinical Site 118, Hermitage, Tennessee, 37076, United States
Texas
Viking Clinical Site 115, Arlington, Texas, 76012, United States
Viking Clinical Site 113, Dallas, Texas, 75203, United States
Viking Clinical Site 220, Edinburg, Texas, 78539, United States
Viking Clinical Site 142, Houston, Texas, 77030, United States
Viking Clinical Site 102, San Antonio, Texas, 78215, United States
Viking Clinical Site 101, San Antonio, Texas, 78229, United States
Viking Clinical Site 143, San Antonio, Texas, 78229, United States
Viking Clinical Site 201, San Antonio, Texas, 78229, United States
Utah
Viking Clinical Site 224, Ogden, Utah, 84405, United States
Virginia
Viking Clinical Site 304, Newport News, Virginia, 23602, United States
Viking Clinical Site 209, Richmond, Virginia, 23249, United States
Viking Clinical Site 312, Richmond, Virginia, 23298, United States
Washington
Viking Clinical Site 317, Seattle, Washington, 98105, United States
VBR
Viking Clinical Site 503, Brussels, VBR, 3000, Belgium
Viking Clinical Site 502, Brussels, 1070, Belgium
Viking Clinical Site 611, Amiens, 80054, France
Viking Clinical Site 612, Créteil, 94000, France
Viking Clinical Site 610, Grenoble, 38700, France
Viking Clinical Site 607, Paris, 75012, France
Viking Clinical Site 603, Paris, 75013, France
Guerrero
Viking Clinical Site 401, Acapulco de Juárez, Guerrero, 39670, Mexico
Nuevo León
Viking Clinical Site 422, Monterrey, Nuevo León, 64000, Mexico
Viking Clinical Site 421, Mexico City, 06700, Mexico
Viking Clinical Site 219, San Juan, 00927, Puerto Rico