CTRI/2025/07/090817进行中（未招募）3 期
A Prospective, Randomized, Multicentric, Double-Blind, Double-Dummy, Placebo controlled, Parallel Group, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Resmetirom Tablets (Strengths 60mg, 80mg and 100mg) in Subjects with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis (Consistent with Stages F2 to F3 Fibrosis)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 22
- 主要终点
- Mean Percentage change in liver fat content.
研究概览
简要总结
This study will be conducted to evaluate the Efficacy and Safety of Resmetirom Tablets in Subjects with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) . Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study.
Subjects will be randomized into one of the three treatment arms either test arm-1, test arm-2 or placebo arm . They will either receive test product Arm 1: Resmetirom Tablets 80 mg or test product Arm 2: Resmetirom Tablets 100 mg or arm 3: Placebo. Primary end point will be mean percentage change in liver fat content . Secondary end point will be proportion of subjects with resolution of NASH with no worsening of fibrosis and proportion of subjects with at least a 1-point improvement in fibrosis stage with no worsening of steatohepatitis etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of NASH.
- •Historical liver biopsy.
- •Biopsy-proven NASH.
- •Subjects should not have received any medication 5) Documented diagnosis of moderate to advanced liver fibrosis.
- •Subjects receiving antidiabetic, antihypertensive, lipid modifying medication(s) as background therapy.
- •Subject is willing to provide written informed consent document and have ability and willingness to adhere to the protocol.
- •Subjects willing to maintain consistent lifestyle habits.
- •Women of childbearing potential must have a negative urine pregnancy test and agree to use highly effective methods of contraception to prevent pregnancy.
排除标准
- •History of cirrhosis or liver-related complications.
- •History of significant alcohol consumption.
- •Subjects with type 1 & 2 diabetes mellitus.
- •Any current or prior history of decompensated liver disease.
- •History or presence of concomitant liver diseases other than NASH at screening.
- •Subjects receiving prohibited drugs.
- •Thyroid diseases.
- •History of weight reduction surgery or planned.
- •History of major or minor surgery or invasive procedure.
- •Subjects with any of the abnormal laboratory values at screening.
- •Subjects with known cases of infection with hepatitis B, hepatitis C or HIV.
- •Subjects had been participated in any clinical trials for NASH or had been participated in any other investigational drug clinical trial.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and neither surgically sterilized nor willing to use reliable contraceptive methods.
- •Male subjects who are engaging in sexual activity with female partner of child-bearing potential and not willing to use reliable contraceptive methods throughout the study duration.
- •Any clinically significant condition that in the investigator’s opinion may hinder the subject’s participation in the study or can interfere with the interpretation of the study results.
- •Subjects with suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
Mean Percentage change in liver fat content.
时间窗: Baseline to week 52
次要结局
- Mean % change in liver fat content(Baseline to Week 24)
- Proportion of subjects with resolution of NASH with no worsening of fibrosis as assessed by Biopsy(EOT/EOS (week 52))
- Proportion of subjects with at least a 1-point improvement in fibrosis stage with no worsening of steatohepatitis(EOT/EOS (week 52))
- Mean absolute change in liver fat.(Baseline to EOT/EOS (week 52).)
- Mean change in liver stiffness and controlled attenuation parameter (CAP)(Baseline to EOT/EOS (week 52))
- Mean change in alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase((GGT))
- Changes in lipid profile [total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, high density lipoproteins (HDL) cholesterol, triglycerides (TG)](Baseline to EOT/EOS (week 52))
- Mean changes in thyroid function tests(Baseline to EOT/EOS (week 52))
研究者
Dr Milan Satia
Ethicare Clinical Trial Services (OPC) Pvt. Ltd.
研究点 (22)
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