Идёт набор NCT06632457

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

Фаза III С лечением Metabolic Dysfunction Associated Steatohepatitis

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 matching survodutide.
Кому может быть актуально: Состояния в реестре: Metabolic Dysfunction Associated Steatohepatitis. 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 Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

Обзор

This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high 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 NASH or MASH improve their 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. All participants regularly receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have 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 is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

Вмешательства

Комбинированный продукт Survodutide
Subcutaneous injection, pre-filled syringe
Комбинированный продукт Placebo matching survodutide
Subcutaneous injection, pre-filled syringe

Первичные конечные точки

Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH [Срок оценки: up to 4.5 years.]

Вторичные конечные точки (12)

Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score [Срок оценки: At baseline and at Week 76.]
Key secondary endpoint: Percentage change from baseline in body weight [Срок оценки: At baseline and at Week 76.]
Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline [Срок оценки: At baseline and at Week 76.]
Key secondary endpoint: Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE) [Срок оценки: At baseline and at Week 76.]
Percentage change from baseline in liver stiffness in FibroScan® VCTE [Срок оценки: At baseline and at Week 76.]
Time to first occurrence of progression to CSPH [Срок оценки: up to 4.5 years.]
Time to first occurrence of any of the hepatic decompensation events (ascites, HE, or portal hypertension-related upper GI bleeding), or worsening of MELD score to ≥15 [Срок оценки: up to 4.5 years.]
Occurrence of all-cause hospitalisation (first and recurrent) [Срок оценки: up to 4.5 years.]
Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE) [Срок оценки: up to 4.5 years.]
Absolute changes from baseline in lipids (mg/dL) [Срок оценки: At baseline and at Week 76.]
Absolute change from baseline in aspartate aminotransferase (AST) (U/L) [Срок оценки: At baseline and at Week 76.]
Absolute change from baseline in alanine aminotransferase (ALT) (U/L) [Срок оценки: At baseline and at Week 76.]

Критерии участия

Критерии включения

Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is >18 years
Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF <5% or FibroScan® with CAP <288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.
Further inclusion criteria apply.

Критерии исключения

Current or history (<5 years) of significant alcohol consumption, defined as an average of >140 g/week in female patients and >210 g/week in male patients, for a period of >3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.
Model of end-stage liver Disease (MELD) score >12 due to liver disease
History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:

Portal hypertension-related upper gastrointestinal (GI) bleeding
Ascites
Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
Any of the following lab test result at screening

Albumin below <3.5 g/dL (<35.0 g/L)
International normalised ratio (INR) >1.3 unless due to therapeutic anticoagulants
Total bilirubin (TBL) >1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL >1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is <20% of TBL.
Alkaline phosphatase >1.5x ULN
PLT <100,000/µL (<100 GI/L)
History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5x ULN
Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
History of liver transplantation or listed for liver transplantation
History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
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