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Набира участници Фаза 3 NCT06318169

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Спонсор: 89bio, Inc.

Налично на: БГ
Обобщение
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
Кой може да участва
Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF) * Biopsy-confirmed MASH with fibrosis stage F2 or F3 * Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants). Key Exclusion Criteria: * Chronic liver diseases other than MASH * Evidence of cirrhosis on screening liver biopsy * Have type 1 diabetes or poorly controlled type 2 diabetes * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L) * Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening Other inclusion and exclusion criteria may apply.
Места на провеждане 26
Argentina (1)
89bio Clinical Study Site
Buenos Aires
Австралия (1)
89bio Clinical Study Site
Brisbane , Queensland
Белгия (1)
89bio Clinical Study Site
Brussels
България (1)
89bio Clinical Study Site
Gorna Oryahovitsa
Канада (1)
89bio Clinical Study Site
Calgary , Alberta
Чехия (1)
89bio Clinical Study Site
Brno
Франция (1)
89bio Clinical Study Site
Amiens
Georgia (1)
89bio Clinical Study Site
Batumi
Германия (1)
89bio Clinical Study Site
Chemnitz
Hong Kong (1)
89bio Clinical Study Site
Hong Kong
Индия (1)
89bio Clinical Study Site
Guwahati , Assam
Израел (1)
89bio Clinical Study Site
Afula
Италия (1)
89bio Clinical Study Site
Bergamo
Япония (1)
89bio Clinical Study Site
Maebashi , Gunma
Mexico (1)
89bio Clinical Study Site
Chihuahua City
Нидерландия (1)
89bio Clinical Study Site
Rotterdam , South Holland
Полша (1)
89bio Clinical Study Site
Katowice
WITHDRAWN
Puerto Rico (1)
89bio Clinical Study Site
Mayagüez
Сингапур (1)
89bio Clinical Study Site
Singapore
South Africa (1)
89bio Clinical Study Site
Cape Town
Южна Корея (1)
89bio Clinical Study Site
Busan
Испания (1)
89bio Clinical Study Site
Barcelona
Taiwan (1)
89bio Clinical Study Site
Chiayi City
Турция (1)
89bio Clinical Study Site
Adana
Великобритания (1)
89bio Clinical Study Site
High Wycombe , Buckinghamshire
САЩ (1)
89bio Clinical Study Site
Birmingham , Alabama
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
13.03.2024
Крайна дата
01.02.2029
Регистрационен номер
NCT06318169
Източник
anzctr
Запитване за медицински туризъм

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