A Randomized, Double-blind, Placebo-controlled Parallel Group Phase 2a Study to Evaluate the Efficacy and Safety of HPG1860 in Subjects With Nonalcoholic Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Safety and tolerability of treatment
研究概览
简要总结
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH.
详细描述
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH. Screening will occur up to 5 weeks prior to randomization; all eligible subjects will have baseline hepatic imaging during Screening, prior to randomization. Approximately 80 eligible subjects will be randomized 1:1:1:1 on Day 1/Week 0 (T1) to receive either HPG1860 3 mg (n = 20), or 5 mg (n = 20), or 8 mg (n = 20), or placebo (n = 20) for 12 weeks. Following a preplanned interim analysis, a dose cohort may be dropped and/or added.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
During this study, subjects, investigators, the Sponsor, and the clinical research organization (CRO) (except specific vendors whose role in study conduct requires their unblinding, eg, personnel operationally associated with the interactive response technology [IRT]) will be blinded to the study intervention assignment. Study team personnel will remain blinded throughout the study with the exception of a Sponsor Committee who will review interim analysis results and make decisions regarding dropping and/or adding a treatment cohort and an unblinded study team member assigned to monitor that at least 6 subjects in each dose cohort had serial PK measurements taken.
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
- •Provision of written informed consent prior to any study-specific procedure.
- •Males and females between 18 and 75 years of age
- •Nonpregnant, nonlactating women.
- •Male subjects must agree to utilize a highly effective method of contraception.
- •Body mass index (BMI) of ≥25 kg/m2 at Screening.
- •Non-cirrhotic NASH subjects.
- •NASH subjects with hepatic fat assessed by a central reader
- •Willing and able to adhere to study restrictions and agree to comply with study protocol.
排除标准
- •Pregnant or lactating females
- •Current significant alcohol consumption
- •Elevated LDL-C with stable dose of statin an or PCSK9 inhibitor
- •Renal dysfunction or nephritic syndrome or a history of nephritis
- •Recent infarction, unstable angina leading to hospitalization, uncontrolled, symptomatic cardiac arrhythmia
- •Uncontrolled hypertension
- •Type 1 diabetes or uncontrolled T2DM
- •Uncontrolled hypothyroidism
- •Liver transplant and/or other significant liver disease or dysfunction
- •HIV antibody positive
- •Known hypersensitivity or formulation excipient
- •Gastrointestinal conditions or procedures that may affect drug absorption
- •Hematologic or coagulation disorders
- •Unstable weight within the last 3 months
- •Active malignancy
- •Unexplained creatine kinase (CK) >3 × ULN
- •Blood donation, blood transfusion
- •Unable to undergo or contraindication to MRI procedure
- •A medical or situational finding that in the investigator's opinion may compromise the subject's safety or ability to complete the study.
研究组 & 干预措施
Placebo
20 subjects will be treated with Placebo once daily at a similar time with or without food.
干预措施: Placebo (Drug)
HPG1860 3 mg
20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
干预措施: HPG1860 (Drug)
HPG1860 5 mg
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
干预措施: HPG1860 (Drug)
HPG1860 8 mg
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
干预措施: HPG1860 (Drug)
结局指标
主要结局
Safety and tolerability of treatment
时间窗: 12 weeks
Number of participants Treatment-emergent adverse events (TEAEs)
次要结局
- Change from baseline (CFB) in liver fat content (LFC) at 4 week(4 week)
- liver fat content(12 week)
- Percentage of subjects with ≥30% reduction in LFC from baseline(4 week and 12 week)