Идёт набор NCT07221188

A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH

Фаза III С лечением Non-alcoholic Fatty Liver Disease

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: Efimosfermin Alfa, Placebo.
Кому может быть актуально: Состояния в реестре: Non-alcoholic Fatty Liver Disease. Базовые параметры: 18 лет — 75 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, Гонконг
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 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

Обзор

This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.

Вмешательства

Препарат Efimosfermin Alfa
Efimosfermin Alfa will be administered
Препарат Placebo
Placebo will be administered

Первичные конечные точки

Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity [Срок оценки: At Week 52]
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity [Срок оценки: At Week 52]
Number of participants with Grade 3 and Grade 4 laboratory abnormalities [Срок оценки: At Week 52]

Вторичные конечные точки (12)

Absolute Change from Baseline in enhanced liver fibrosis (ELF) score [Срок оценки: Baseline (Day 1) and up to Week 52]
Percent Change from Baseline in ELF score [Срок оценки: Baseline (Day 1) and up to Week 52]
Number of participants achieving an improvement in ELF score greater than equal to 0.5 [Срок оценки: At Week 52]
Absolute Change from Baseline in vibration-controlled transient elastography (VCTE)- liver stiffness measurement (LSM) scores [Срок оценки: Baseline (Day 1) and up to Week 52]
Percent Change from Baseline in VCTE- LSM scores [Срок оценки: Baseline (Day 1) and up to Week 52]
Number of participants achieving a change from Baseline in VCTE-LSM >=30 percentage (%) [Срок оценки: Baseline (Day 1) and up to Week 52]
Absolute Change from Baseline in magnetic resonance elastography (MRE) scores in the subset of participants [Срок оценки: Baseline (Day 1) and up to Week 52]
Percent Change from Baseline in the subset of participants with magnetic resonance elastography (MRE) scores [Срок оценки: Baseline (Day 1) and up to Week 52]
Absolute Change from Baseline in hepatic fat fraction (HFF) by magnetic resonance imaging (MRI)- derived proton density fat fraction (PDFF) [Срок оценки: Baseline (Day 1) and up to Week 52]
Percent Change from Baseline in HFF by MRI-PDFF [Срок оценки: Baseline (Day 1) and up to Week 52]
Absolute Change from Baseline in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (International units per liter) [Срок оценки: Baseline (Day 1) and up to Week 52]
Absolute Change from Baseline in ALT and AST ratio (ALT/AST) [Срок оценки: Baseline (Day 1) and up to Week 52]

Критерии участия

Критерии включения

Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
Age >=18 through <=75 years at enrolment
History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
History or presence of known or suspected MASH with evidence of fibrosis

Критерии исключения

ALT or AST >=5 × upper limit of normal (ULN)
Total bilirubin (BILI) >=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of >=1.3 mg/dL and direct BILI is <=20% of total BILI; otherwise, the individual will be excluded.
Serum albumin <=3.5 grams per deciliter (g/dL)
International normalized ratio (INR) >=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.
Alkaline phosphatase (ALP) >=2 × ULN
Platelet (PLT) count <140 000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor
Serum creatinine >=1.5 mg/dL or creatinine clearance <=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation.
Alpha-fetoprotein >=20 nanogram per milliliter (ng/mL)
HbA1c >=9.0%
Model for End-Stage Liver Disease (MELD) 3.0 score >=12 unless the score is elevated in the absence of liver dysfunction (eg, Gilbert's syndrome)
Phosphatidylethanol (PEth) >=80 nanogram per milliliter (ng/mL) at Screening
Known co-infection with any of the following: a. Human immunodeficiency virus; b. Hepatitis B virus; c. Hepatitis C virus (HCV); d. Hepatitis D virus; or e. Hepatitis E virus.
Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis, or any history or evidence of cirrhosis; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.
Current or history of excessive alcohol intake for >=3 months within the 12-month period prior to Screening

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

Здоровые добровольцы: Нет