A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) With Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment
研究概览
简要总结
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele
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)
盲法说明
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants in this arm will receive placebo
干预措施: Placebo (Other)
AZD2693 dose 1
Participants will receive AZD2693 dose 1
干预措施: AZD2693 (Drug)
AZD2693 dose 2
Participants will receive AZD2693 dose 2
干预措施: AZD2693 (Drug)
结局指标
主要结局
Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment
时间窗: after 52 weeks
To assess the effect of AZD2693 versus placebo on histological resolution of NASH in participants with non-cirrhotic NASH with fibrosis and PNPLA3 risk allele carriers after 52 weeks
次要结局
- Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment(after 52 weeks)
- Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment(after 52 weeks)
- Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment(after 52 weeks)