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הניסוי הקליני NCT04173065 (VOYAGE) עבור NASH - דלקת כבד שומנית לא אלכוהולית הוא הושלם. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים

A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH (VOYAGE) שלב II 248 סמיות כפולה

הושלם
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT04173065 (VOYAGE) נערך כדי לבדוק את טיפול עבור NASH - דלקת כבד שומנית לא אלכוהולית. זהו מחקר שלב II מסוג התערבותי שנמצא כעת במצב הושלם. המחקר התחיל ב-15 בנובמבר 2019 ותוכנן לכלול 248 משתתפים. המחקר נוהל על ידי ויקינג תרפיוטיקס ותאריך הסיום היה 26 בינואר 2024. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-14 ביוני 2024.
סיכום קצר
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...הצג עוד
כותרת רשמית

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

מצבים רפואיים
NASH - דלקת כבד שומנית לא אלכוהולית
מזהי מחקר נוספים
  • VOYAGE
  • VK2809-202
מספר NCT
תחילת המחקר (בפועל)
2019-11-15
עדכון אחרון שפורסם
2024-06-14
סיום המחקר (מוערך)
2024-01-26
משתתפים (מתוכנן)
248
סוג המחקר
התערבותי
שלב
שלב II
סטטוס
הושלם
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
מרובע
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
פלצבו להשוואהPlacebo
פלצבו
Capsule
ניסי1.0 mg
VK2809
Capsule
ניסי2.5mg
VK2809
Capsule
ניסי5.0 mg
VK2809
Capsule
ניסי10 mg
VK2809
Capsule
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
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
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
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
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
  1. 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;

  2. 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:

    1. NASH Clinical Research Network (CRN) fibrosis stage 1 to stage 3 and
    2. 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
  3. Have a screening MRI-PDFF with ≥ 8% liver fat fraction;

  4. Male and females be 18 to 75 years of age, inclusive, at screening;

  1. 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
  2. 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;
  3. 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;
  4. TSH outside central laboratory reference range;
  5. Free T4 outside central laboratory reference range;
  6. Cardiac troponin I (cTnI) and creatine kinase MB isoenzyme (CK-MB) > Upper Limit of Normal (ULN) at screening;
  7. Serum albumin < 3.5 g/dL;
  8. International normalized ratio (INR) > 1.3;
  9. Total bilirubin > 1.2 X ULN (except in presence of Gilbert synd
  10. Strong or moderate inhibitors or inducers of CYP3A4 are prohibited during the study period
  11. 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
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Connecticut

Viking Clinical Site 156, New Haven, Connecticut, 06510, United States

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Viking Clinical Site 137, Cincinnati, Ohio, 45249, United States

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Viking Clinical Site 148, Philadelphia, Pennsylvania, 19107, United States
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Viking Clinical Site 127, Greenville, South Carolina, 29605, United States

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Viking Clinical Site 227, Clarksville, Tennessee, 37040, United States
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Viking Clinical Site 115, Arlington, Texas, 76012, United States
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