A Phase 2a, Single Dose, Open-label, Dose Exploration Study to Assess the PK-PD Activity, Safety, and Tolerability of GSK4532990 in Adult. Participants With NASH or Suspected NASH
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels
研究概览
简要总结
The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated. The total study duration for each participant will be approximately 24-36 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Participant must be 18 to 75 years of age.
- •Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed for the study.
- •Participants who have proven diagnosis of NASH or suspected NASH based on defined study criteria.
- •Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
排除标准
- •Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
- •Cirrhosis or current unstable liver or biliary disease.
- •Other causes of liver disease including, but not limited to, alcohol-related liver disease, autoimmune disorders.
- •Known weight loss of ≥5% within 3 months prior to Screening.
- •Weight reduction surgery or procedures within 2 years of Screening.
- •Any contraindication to undergoing liver biopsy.
- •Any contraindication to undergoing Magnetic Resonance Imaging or FibroScan®.
研究组 & 干预措施
GSK4532990 Dose 1
Participants will receive GSK4532990 Dose 1
干预措施: GSK4532990 (Drug)
GSK4532990 Dose 2
Participants will receive GSK4532990 Dose 2
干预措施: GSK4532990 (Drug)
GSK4532990 Dose 3
Participants will receive GSK4532990 Dose 3
干预措施: GSK4532990 (Drug)
GSK4532990 Dose 4
Participants will receive GSK4532990 Dose 4
干预措施: GSK4532990 (Drug)
结局指标
主要结局
Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels
时间窗: Baseline (Day 1) and up to Week 28
Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels
时间窗: Baseline (Day 1) and up to Week 28
次要结局
- Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990(Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose)
- Maximum observed concentration (Cmax) of GSK4532990(Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose)
- Percent change from baseline in the. observed HSD17B13 protein expression. levels(Baseline and Weeks 8, 12, or 28 post-dose)
- Percent change from baseline in the. observed HSD17B13 mRNA expression. levels(Baseline and Weeks 8, 12, or 28 post-dose)