Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 2 NCT05583344

Phase 2b Study of GSK4532990 in Adults With NASH

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Nonalcoholic Fatty Liver Disease Non-alcoholic Fatty Liver Disease

Спонсор: GlaxoSmithKline

Налично на: БГ
Обобщение
The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.
Кой може да участва
Inclusion Criteria: * Body Mass Index (BMI) ≥25 kilogram per meter square (kg/m\^2) (all ethnic origins) except for Asian participants who qualify for the study with BMI ≥23 kg/m2 at Screening. * In the opinion of the investigator, there are features of metabolic syndrome and NAFLD is the most likely cause of liver disease. Metabolic syndrome may include type 2 diabetes mellitus (T2DM), obesity, dyslipidemia and hypertension. * A liver biopsy at baseline showing NAFLD Activity Score (NAS) \>=4 with at least 1 point each in steatosis, inflammation and ballooning and either Fibrosis 3 or Fibrosis 4 using NASH CRN Scoring System. * Able and willing to comply with all study assessments, including a liver biopsy at Week 52. Exclusion Criteria: * Current alcohol consumption ≥14 standard drinks (24 units, 196 g ethanol) per week for females or ≥21 standard drinks (37 units, 294g ethanol) per week for males. * Weight reduction surgery or procedures (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1 and/or planned during the study. * History of cancer within previous 2 years from Screening 1, except basal or squamous cell carcinoma of the skin or in situ cervical carcinoma or any other type of cancer which has been treated medically or surgically with curative outcome.
Места на провеждане 17
Argentina (1)
GSK Investigational Site
Buenos Aires
Австралия (1)
GSK Investigational Site
Nedlands , Western Australia
Белгия (1)
GSK Investigational Site
Brussels
Канада (1)
GSK Investigational Site
Calgary , Alberta
Франция (1)
GSK Investigational Site
Angers
Гърция (1)
GSK Investigational Site
Athens
Индия (1)
GSK Investigational Site
Bhubaneswar
Италия (1)
GSK Investigational Site
Florence
Япония (1)
GSK Investigational Site
Fukui
Mexico (1)
GSK Investigational Site
Cuernavaca Morelos
Panama (1)
GSK Investigational Site
Panama City
Puerto Rico (1)
GSK Investigational Site
San Juan
Южна Корея (1)
GSK Investigational Site
Incheon
Испания (1)
GSK Investigational Site
Barcelona
Турция (1)
GSK Investigational Site
Ankara
Великобритания (1)
GSK Investigational Site
Cannock
САЩ (1)
GSK Investigational Site
Homewood , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
02.01.2023
Крайна дата
05.04.2027
Регистрационен номер
NCT05583344
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.