jRCT2031240540尚未招募不适用
A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with non-cirrhotic non-alcoholic steatohepatitis/metabolic associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 126
- 主要终点
- Resolution of MASH without worsening of liver fibrosis
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •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 (NAS >=4, with at least 1 point in inflammation and ballooning each) and fibrosis stage F2-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomisation.
- •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.
- •Further criteria apply
排除标准
- •Liver related:
- •Any of the following liver laboratory test abnormalities at screening:
- •Serum AST and/or ALT elevation >=5x ULN
- •Platelet count <140 000/mm3 (<140 GI/L)
- •Alkaline phosphatase >2x ULN
- •Abnormal synthetic liver function as defined by screening central laboratory evaluation:
- •o Albumin below <3.5 g/dL (35.0 g/L)
- •o OR International normalised ratio (INR) of prothrombin time >1.3 (unless participant is on anticoagulants)
- •o OR total serum bilirubin concentration >=1.5x ULN (participants with a documented history of Gilberts syndrome can be enrolled if the direct bilirubin is within normal reference range)
- •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 (including hepatic encephalopathy, variceal bleeding, ascites, and spontaneous bacterial peritonitis)
- •MELD score >=12 due to liver disease
- •Treatment with any medication for the indication obesity within 3 months before screening biopsy or historical biopsy time point
- •10 History of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x ULN as measured by the central laboratory at screening
- •11 Major surgery (in the opinion of the investigator) performed within 3 months prior to screening or planned during the trial
- •Further exclusion criteria apply
结局指标
主要结局
Resolution of MASH without worsening of liver fibrosis
时间窗: Week 52
Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score
At least a 1-point improvement in fibrosis stage with no worsening of MASH
时间窗: Week 52
At least a 1-point improvement in fibrosis stage with no worsening of MASH
Time to first occurrence of composite endpoint
时间窗: EoS
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. Progression to cirrhosis is defined as histological fibrosis score CRN F4. MELD = Model for End-stage Liver Disease CSPH = clinically significant portal hypertension
次要结局
- Time to first occurrence of any of the adjudicated components of the composite endpoint(EoS)
- Improvement of liver fat content (LFC)(Week 52, Week 114)
- Absolute change from baseline in LFC in MRI-PDFF(Week 52, Week 114)
- Absolute change from baseline in Alanine aminotransferase (ALT)(Week 52, Week 114)
- Absolute change from baseline in Aspartate aminotransferase (AST)(Week 52, Week 114)
- Absolute change from baseline in systolic blood pressure (SBP)(Week 52, Week 114)
- Absolute change from baseline in diastolic blood pressure (DBP)(Week 52, Week 114)
- Absolute changes from baseline in lipids(Week 52, Week 114)
- Absolute change from baseline in free fatty acids(Week 52, Week 114)
- Progression to cirrhosis(Week 52)
- Absolute change from baseline in ELF score(Week 52)
- Percentage change from baseline in body weight(Week 52)
- Absolute change from baseline in HbA1c(Week 52)
- Absolute change from baseline in liver stiffness assessed by VCTE(Week 52)
- Achievement of no progression of fibrosis assessed by central pathology(Week 52)
- Percentage change from baseline in body weight (Week 114)(Week 114)
- Absolute change from baseline in HbA1c (Week 114)(Week 114)
- Absolute change from baseline in ELF score (Week 114)(Week 114)
- Absolute change from baseline in liver stiffness assessed by VCTE (Week 114)(Week 114)
- Achievement of no progression of fibrosis assessed by central pathology (EoT)(EoT)
- Occurrence of all-cause hospitalisation(EoS)
研究者
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