A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALG-055009 in Non-Cirrhotic Adults With Metabolic Dysfunction-Associated Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 40
- 主要终点
- Percent relative change from baseline in liver fat content
研究概览
简要总结
This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin [softgel] capsule) for 12 weeks.
详细描述
This is a double-blind, randomized, placebo-controlled Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin [softgel] capsule) for 12 weeks. The study will be conducted in approximately 100 adult non-cirrhotic subjects with presumed MASH and liver fibrosis (F1-F3). The study will be conducted at up to approximately 45 sites throughout the United States of America.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Male or female, 18 to 75 years of age
- •Body mass index (BMI) ≥ 25 kg/m2
- •Diagnosis of presumed NASH/MASH with F1-F3 liver fibrosis based on one of the following:
- •Liver biopsy within 6 months prior to screening showing a NAFLD activity score (NAS) of ≥4 with at least a score of 1 in each of the NAS components; OR
- •Having ≥2 metabolic syndrome criteria and a screening FibroScan liver stiffness measurement between 7 - 20 kPa
- •Screening FibroScan with CAP score of >300 dB/m
- •Screening MRI-PDFF with ≥10% liver fat content
排除标准
- •History or clinical evidence of chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)
- •History or current evidence of cirrhosis
- •History of liver transplantation or known planned liver transplantation
- •History or current evidence of a pituitary disorder or hyperthyroidism
- •Untreated clinical or subclinical hypothyroidism; or on thyroid replacement therapy at screening or within the last 6 months prior to screening.
- •TSH, free T4, or Total T3 >1.1 x ULN or <0.9 x LLN
- •Clinically concerning abnormal ECG or cardiac history
- •HbA1c ≥9.5%
- •Platelet count ≤135,000/mm3
- •ALT or AST >5 x ULN
- •INR >1.3
- •Albumin <3.5 g/dL
- •eGFR <45 mL/min/1.73 m2
研究组 & 干预措施
ALG-055009 softgel capsule 0.3mg
ALG-055009 softgel capsule 0.3mg Daily for 12 weeks
干预措施: ALG-055009 (Drug)
ALG-055009 softgel capsule 0.5mg
ALG-055009 softgel capsule 0.5mg Daily for 12 weeks
干预措施: ALG-055009 (Drug)
ALG-055009 softgel capsule 0.7mg
ALG-055009 softgel capsule 0.7mg Daily for 12 weeks
干预措施: ALG-055009 (Drug)
ALG-055009 softgel capsule 0.9mg
ALG-055009 softgel capsule 0.9mg Daily for 12 weeks
干预措施: ALG-055009 (Drug)
Placebo
Placebo softgel capsule Daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percent relative change from baseline in liver fat content
时间窗: 12 weeks
Percent relative change from baseline in liver fat content by MRI-PDFF at Week 12
次要结局
- Absolute change from baseline in liver fat content(12 weeks)
- Proportion of subjects with ≥30% relative reduction in liver fat content(12 weeks)
- Proportion of subjects with normalization (<5%) in liver fat content(12 weeks)
- Proportion of subjects with ≥50% relative reduction in liver fat content(12 weeks)
- Proportion of subjects with ≥70% relative reduction in liver fat content(12 weeks)