NCT06613698招募中2 期
A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults With Alcohol-related Liver Disease (ALD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 393
- 试验地点
- 139
- 主要终点
- Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 52 (kiloPascal)
研究概览
简要总结
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent prior to the performance of any study-specific procedures.
- •Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
- •In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD.
- •A female participant is eligible to participate after meeting additional pre-defined criteria.
- •Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
- •Participant has advanced chronic liver disease
排除标准
- •Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)
- •Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets, International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria.
- •Current malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible.
- •Prior organ transplant or current listing or active consideration for organ transplant during the screening period (except for corneal transplants).
- •Chronic or acute, including partial, known portal vein thrombosis.
- •Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.
- •Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening.
- •Poorly controlled hypertension
- •Clinical suspicion of rhabdomyolysis during the screening period
- •Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and/or low blood fibrinogen level.
- •Body Mass Index (BMI) >35 kg/m2 at screening
- •Any liver-related clinical event that started (onset) <8 weeks prior to Baseline (D1).
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
GSK4532990 Dose 1
Experimental
干预措施: GSK4532990 (Drug)
GSK4532990 Dose 2
Experimental
干预措施: GSK4532990 (Drug)
GSK4532990 Dose 3
Experimental
干预措施: GSK4532990 (Drug)
GSK4532990 Dose 4
Experimental
干预措施: GSK4532990 (Drug)
结局指标
主要结局
Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 52 (kiloPascal)
时间窗: Baseline (Day 1) and up to Week 52
Liver stiffness will be measured by vibration-controlled transient elastography (VCTE) using the FibroScan® device.
Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 52
时间窗: Baseline (Day 1) and up to Week 52
MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to 8 weeks
Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests
时间窗: Up to 8 weeks
次要结局
- Change from baseline in serum AST at Week 52(Baseline (Day 1), and at Week 52)
- Change from baseline in Enhanced Liver Fibrosis (ELF™) score at Week 52(Baseline (Day 1), and at Week 52)
- Maximum plasma concentration (Cmax) of GSK4532990(Up to Day 4)
- Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990(Up to Day 4)
- Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990(Up to 24 hours)
- Plasma half-life (t1/2) of GSK4532990(Up to Day 4)
- Apparent clearance (CL/F) of GSK4532990(Up to Day 4)
- Time to maximum concentration (tmax) of GSK4532990(Up to Day 4)
- Apparent terminal phase volume of distribution (Vz/F) of GSK4532990(Up to Day 4)
- Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990(Up to Day 3)
- Maximum observed plasma concentration (Cmax) of GSK4532990(Up to Day 3)
研究者
研究点 (139)
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