A Phase II Proof-of-Concept Study Assessing the Efficacy and Safety of AD64 in Patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The proportion of patients achieving more than 30 percent relative reduction in hepatic fat on MRI PDFF at 12 and 36 weeks
研究概览
简要总结
| This is a 4-arm randomized, double-blind, placebo-controlled design, with patients receiving either AD64 500 mg, AD64 1000 mg or matching placebo twice daily of subjects to study groups using applicable randomization schedule that will be reviewed and approved by an independent statistician. |
1. Participants: The trial will include adults with confirmed MASH as per EASL guidelines.
2. Randomization: An adequate number of patients will be screened to randomize in 2:2:1:1 ratio, 300 patients into four treatment groups 100 patients in AD64 500 mg BID, 100 patients in AD64 1000mg BID and 50 patients each on two placebo groups, to have approximately 300 patients completing the study from each treatment group
3. Dosing: Participants will receive either AD64 500 mg, AD64 1000 mg or matching placebo groups twice daily for 52 weeks
Duration: The treatment duration will be 52 weeks, with liver biopsies conducted at baseline and at the end of the study to assess histological changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 to 75 years
- •Diagnosis of MASH as per EASL guidelines
- •MRI PDFF fat fraction more than 8 percent obtained during the screening period (baseline MRI-PDFF) or a historic MRI PDFF less than or equal to 8 weeks old at the time of randomization.
- •Liver enzymes: Alanine transaminase and Aspartate transaminase levels less than or equal to 5 times upper limit of normal
- •Body mass index BMI 25 to 45 kg per meter square
- •Stable dyslipidemia therapy for more than 30 days prior to randomization.
- •Stable body weight: 5 percent for at least 3 months prior to screening.
排除标准
- •History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
- •Regular use of drugs historically associated with NAFLD
- •History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
- •Weight gain or loss more than total body weight within 12 weeks prior to randomization
- •HbA1c more than 9.0percent
- •Presence or history of hepatic decompensation eg ascites, variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis) or liver transplantation; hepatocellular carcinoma; and gastro-esophageal varices within the past 360 days before screening.
- •Model for End-stage Liver Disease score more than or equal to 12, as determined at Screening unless due to therapeutic anti coagulation or Gilbert syndrome
- •Chronic liver diseases
- •Has an active autoimmune disease.
结局指标
主要结局
The proportion of patients achieving more than 30 percent relative reduction in hepatic fat on MRI PDFF at 12 and 36 weeks
时间窗: The proportion of patients achieving more than 30 percent relative reduction in hepatic fat on MRI PDFF at 12 and 36 weeks
次要结局
- To evaluate the safety & tolerability of the investigational medicinal product(52 weeks)
研究者
Dr Shiran Shetty
KMC Manipal