A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Master Protocol Clinical Trial to Investigate the Efficacy and Safety of HRS-4729 Injection and HRS9531 Injection in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Обзор

The purpose of this study is to investigate the efficacy and safety of HRS-4729 injection and HRS9531 injection in adult participants with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.

Вмешательства

• Препарат HRS-4729 Injection
  HRS-4729 Injection; high dose, low dose
• Препарат HRS9531 Injection
  HRS9531 Injection; high dose, low dose
• Препарат HRS-4729 Injection Placebo
  HRS-4729 Injection Placebo
• Препарат HRS9531 Injection Placebo
  HRS9531 Injection Placebo

Первичные конечные точки

• Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) [Срок оценки: Baseline, Week 32]

Вторичные конечные точки (5)

• Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) [Срок оценки: Baseline, Week 52]
• Percentage of Participants With Absence of MASH With no Worsening of Fibrosis on Liver Histology [Срок оценки: Baseline, Week 52]
• Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology [Срок оценки: Baseline, Week 52]
• Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage on Liver Histology [Срок оценки: Baseline, Week 52]
• Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Baseline, Week 56]

Критерии участия

Критерии включения

• Able and willing to provide a written informed consent
• Participants must have histologic diagnosis of MASH by liver biopsy
• Have liver fat content ≥8%
• Participants must have a body mass index (BMI) ≥24 kilograms per square meter (kg/m²) and ≤40 kg/m² with stable body weight for at least 3 months

Критерии исключения

• Model for End-Stage Liver Disease (MELD) score > 12, or Child-Pugh (CTP) score > 6
• Known or suspected history of excessive alcohol consumption or alcohol dependence within 12 months prior to screening
• History of liver cirrhosis and/or liver decompensation, including but not limited to ascites, hepatic encephalopathy, esophageal or gastric variceal bleeding, etc.
• Previous or current liver disease due to other causes, including but not limited to: alcoholic steatohepatitis (ASH), drug-induced liver injury (DILI), viral hepatitis, autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hereditary hepatobiliary diseases (e.g., hemochromatosis, α1-antitrypsin deficiency, Wilson's disease, etc.), occupational toxic liver disease, known or suspected hepatocellular carcinoma (HCC), etc.
• History of or planned organ transplantation (e.g., liver transplant) or bone marrow transplantation during the study period
• Use of GLP-1 receptor agonists (including multi-target drugs or compound preparations containing GLP-1 receptor agonists) within 3 months prior to screening, or previous discontinuation of GLP-1 receptor agonists due to safety/tolerance reasons
• Known or suspected hypersensitivity to GLP-1 and/or GIP and/or GCG receptor agonists and/or their excipient

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Beijing Tsinghua Changgung Hospital — Пекин
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу

Идентификаторы

NCT: NCT07660848 · HRS-4729-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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