NCT05989711已完成2 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 52
- 主要终点
- Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis
研究概览
简要总结
Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.
详细描述
A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Male or female 18-75 years
- •Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening
- •A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis [0-3], lobular inflammation [0-3], and hepatocyte ballooning [0-2])
- •NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation
- •Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment
- •BMI ≥ 27.0 kg/m2
- •Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening
- •Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005)
- •Liver fat content by MRI-PDFF ≥ 8%
排除标准
- •Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening
- •History or clinical evidence of Type 1 diabetes mellitus
- •Hemoglobin A1c (HbA1c) > 9.5% or clinically significant persistent hyperglycemia
- •Liver conditions:
- •History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites
- •Documented causes of chronic liver disease other than NASH
- •ALT or AST laboratory values > 5 × ULN
结局指标
主要结局
Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis
时间窗: 24 weeks
Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis)
时间窗: 24 weeks
次要结局
- Change in HbA1c (%)(24 weeks and 48 weeks)
- Absolute change in alanine aminotransferase (ALT)(24 weeks and 48 weeks)
- Change in glucose (mg/dL)(24 weeks and 48 weeks)
- Absolute change in Enhanced Liver Fibrosis (ELF) score(24 weeks and 48 weeks)
- Relative change (%) in liver fat content by MRI-PDFF(24 weeks and 48 weeks)
- Relative (%) change in body weight(24 weeks and 48 weeks)
- Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks(24 weeks)
- Absolute change in Fibroscan-AST (FAST) score(24 weeks and 48 weeks)
- Change in systolic and diastolic blood pressure (mmHg)(24 weeks and 48 weeks)
- The number of subjects with treatment emergent adverse events(48 weeks)
- Absolute change in MRI-based corrected T1 (cT1) imaging(24 weeks and 48 weeks)
- Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)(24 weeks and 48 weeks)
- Change in heart rate (beats per minute)(24 weeks and 48 weeks)
研究者
研究点 (52)
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