Идёт набор NCT06632444

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

Фаза III С лечением Metabolic Dysfunction Associated Steatohepatitis (MASH) Liver Fibrosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Survodutide, Placebo.
Кому может быть актуально: Состояния в реестре: Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Австрия, Бельгия +31
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis

Обзор

This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.

Вмешательства

Комбинированный продукт Survodutide
Subcutaneous injection, prefilled syringe
Комбинированный продукт Placebo
Subcutaneous injection, prefilled syringe

Первичные конечные точки

Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score [Срок оценки: Baseline and at Week 52.]
Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH [Срок оценки: Baseline and at Week 52.]
Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH [Срок оценки: Up to 7 years.]

Вторичные конечные точки (12)

Key secondary endpoint part 1: Percentage change from baseline in body weight [kg] [Срок оценки: Baseline and at Week 52.]
Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) [%] [Срок оценки: Baseline and at Week 52.]
Key secondary endpoint part 1: Absolute change from baseline in enhanced liver fibrosis (ELF) score [Срок оценки: Baseline and at Week 52.]
Key secondary endpoint part 1: Absolute change from baseline in liver stiffness [kPa] assessed by vibration-controlled transient elastography (VCTE) [Срок оценки: Baseline and at Week 52.]
Key secondary endpoint part 1: Achievement of no progression of fibrosis assessed by central pathology (yes/no) [Срок оценки: Baseline and at Week 52.]
Key secondary endpoint part 2: Percentage change from baseline in body weight [kg] [Срок оценки: At baseline and at Week 114]
Key secondary endpoint part 2: Absolute change from baseline in HbA1c [%] [Срок оценки: At baseline and at Week 114]
Key secondary endpoint part 2: Absolute change from baseline in ELF score [Срок оценки: At baseline and at Week 114.]
Key secondary endpoint part 2: Absolute change from baseline in liver stiffness [kPa] assessed by VCTE [Срок оценки: At baseline and at Week 114.]
Key secondary endpoint part 2: Achievement of no progression of fibrosis assessed by central pathology (yes/no) [Срок оценки: At baseline and at 7 years.]
Key secondary endpoint part 2: Occurrence of all-cause hospitalisation (first and recurrent) [Срок оценки: Up to 7 years.]
Key secondary endpoint part 2: Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)5-point major adverse cardiac event (5P-MACE) [Срок оценки: Up to 7 years.]

Критерии участия

Критерии включения

Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent
Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4
Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used
Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply

Критерии исключения

Any of the following liver laboratory test abnormalities at screening:

Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)
Platelet count <140 000/mm\^3 (<140 GI/L)
Alkaline phosphatase >2x upper limit of normal (ULN)
Abnormal synthetic liver function as defined by screening central laboratory evaluation:

Albumin below <3.5 g/dL (35.0 g/L)
OR International normalised ratio (INR) of prothrombin time >1.3
OR total serum bilirubin concentration ≥1.5x ULN
Any history or evidence of acute or chronic liver disease other than MASH
Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
History of or current diagnosis of hepatocellular carcinoma
History of or planned liver transplant
Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
History of portal hypertension or presence of decompensated liver disease
Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Двойное слепое
Основная цель: Лечение