CTRI/2025/06/089905招募中3 期
A Randomized, Multi-Centric, Double Blind, Double Dummy, Placebo-Controlled, Parallel Group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Resmetirom Oral Tablets in Adult Subjects with Nonalcoholic Steatohepatitis.
Torrent Pharmaceuticals Ltd, Torrent Research Centre26 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2025年8月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 201
- 试验地点
- 26
- 主要终点
- Proportion of subjects with NASH resolution with no worsening of fibrosis
研究概览
简要总结
This study will be a phase-III, multi-centric, double blind, double dummy, randomized, placebo-controlled, parallel-group clinical trial.
Total duration of the study will be approximately 56 weeks including 4 weeks of screening period, followed by 52 weeks of treatment period.
Total of 201 patients with with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) will be enrolled and randomized to receive either resmetirom 80 mg oral tablet in test arm-1 , resmetirom 100 mg oral tablet in test arm- 2 or placebo of resmetirom oral tablet in comparator arm for 52 weeks.
Efficacy assessment will be will be performed using histological assessment of liver biopsy, NASH fibrosis related biomarkers like APRI, FIB-4, NFS, BARD Score, liver function tests, and lipid profile tests. Patients will be monitored throughout the study for safety assessment and incidence of any adverse effects.
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
- •Male or female between 18-70 (both inclusive) years of age, at the time of signing informed consent.
- •Diagnosis of NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) confirmed by liver biopsy, with non-alcoholic fatty liver disease (NAFLD) activity score [NAS] greater than or equal to 4, with at least 1 point in steatosis, ballooning degeneration, and lobular inflammation each, conducted during the screening period or by a historical biopsy conducted within 6 months prior to screening.
- •Subjects receiving antidiabetic, antihypertensive, lipid modifying medication(s) as background therapy should be on a stable dose for at least 3 months before screening.
- •Subject is willing to provide written informed consent document and have ability and willingness to adhere to the protocol.
排除标准
- •Subjects with history of alcohol consumption of greater than 30 gm/day for men, greater than 20 gm/day for women for 3 consecutive months in the last 2 years.
- •History or presence of cirrhosis at screening.
- •Any current or prior history of decompensated liver disease including ascites requiring medical management, hepatic encephalopathy (HE), or variceal bleeding.
- •History or presence of concomitant liver diseases other than NASH at screening.
- •History of liver transplantation or hepatocellular carcinoma (HCC).
- •Subjects receiving predefined prohibited drugs within 24 weeks prior to screening.
- •Subjects with thyroid diseases either hyperthyroidism or hypothyroidism.
- •Significant (more than 5%) weight gain or loss in 12 weeks prior to screening.
- •Any weight reduction surgery in the 2 years prior to screening or planned during the study period.
- •Subjects with history of major or minor surgery or invasive procedure within 24 weeks prior to screening.
- •11.Subjects with any planned major or minor surgery or invasive procedure within the next 56 weeks from the day of screening.
- •Subjects suffering from Type 1 diabetes.
- •Subjects with Type 2 diabetes with poor glucose control [defined as glycated haemoglobin (HbA1C) greater than or equal to 9.5% within 12 weeks] or subjects who required to take insulin treatment within 12 weeks prior to screening.
- •Subjects with any of the following laboratory values at screening: • Platelets less than 140000/µL • International normalised ratio (INR) greater than 1.4 (in the absence of anticoagulants) • Direct bilirubin greater than 0.3 mg/dL.
- •Total bilirubin greater than 1.5x ULN • Serum albumin less than 3.5 g/dL (35.0 g/L) • Estimated Glomerular Filtration Rate (eGFR) less than 45 ml/min/1.73 m2 • ALP greater than or equal to 2x ULN • AST {serum glutamic oxaloacetic transaminase (SGOT)}, ALT {serum glutamic pyruvic transaminase (SGPT)} greater than or equal to 5x ULN
- •History or presence of cholelithiasis, acute cholecystitis, and obstructive pancreatitis (gallstone).
- •History of anaemia or hemoglobinopathy and or hemoglobin less than 10 g/dL for men, hemoglobin less than 9 g/dL for women at screening.
- •Subjects with any of the following: myocardial infarction, stroke or unstable angina and/or transient ischaemic attack within 24 weeks prior to screening.
- •Subjects with New York Heart Association (NYHA) Class III or IV heart failure.
- •Poorly controlled hypertension (systolic blood pressure greater than 160 mm Hg, or diastolic blood pressure greater than 100 mm Hg) at the screening visit.
- •Subject with history or presence of human immunodeficiency viruses (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
- •Subject with history or presence of malignant neoplasms within the last 5 years or currently receiving any anticancer medication.
- •Known allergy, sensitivity or intolerance to the study drug.
- •Subjects had been participated in any clinical trials for NASH within 24 weeks prior to the screening or had been participated in any other investigational drug clinical trial within 12 weeks prior to the screening.
- •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 throughout the study duration.
- •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.
结局指标
主要结局
Proportion of subjects with NASH resolution with no worsening of fibrosis
时间窗: 52 Week
次要结局
- Proportion of subjects with at least a 1-point improvement in fibrosis stage with no worsening of steatohepatitis(52 Week)
- Mean change in NAS score from baseline(52 Week)
- Mean change in alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT) from baseline(24 week & 52 Week)
- Proportion of subjects achieving ALT normalization(24 Week & 52 Week)
- Mean change in fasting lipid profile [total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, high density lipoproteins (HDL) cholesterol, triglycerides (TG)] from baseline(24 Week & 52 Week)
- Change in non-invasive biomarkers of fibrosis like AST-to-Platelet Ratio Index (APRI), NAFLD fibrosis score (NFS), fibrosis-4 (FIB4), BARD score from baseline(52 Week)
- Number of treatment emergent adverse events (TEAEs).(Throughout the Study)
研究者
Dr Amarinder Singh
Torrent Pharmaceuticals Limited Torrent Research Centre
研究点 (26)
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