CTIS2023-505141-48-00招募中1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/MetabolicDysfunction-Associated Steatohepatitis (MASH) and Fibrosis - AK-US-001-0105
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Males and non-pregnant, non-lactating females between 18–80 (between 19–80 in the Republic of Korea) years of age, inclusive, on the day of signing informed consent., Female subjects of childbearing potential (see definition in Appendix C) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at baseline/Day 1., Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix C., Previous history or presence of T2D (as determined by medical history or based on screening lab values if previously undiagnosed [i.e., HbA1c = 6.5%]) or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose), Body mass index (BMI) = 25.0 kg/m2, Subjects who do not have a historical liver biopsy specimen that meets Inclusion Criteria 7 must meet either inclusion criterion 4a OR 4b prior to collection of a liver biopsy specimen during the Screening visit: a.FibroScan® liver stiffness measurement (LSM) > 7.5 kPa, OR b.Enhanced Liver Fibrosis (ELF) score = 7.7. Note: If a historical value for FibroScan® is available within 12 weeks prior to randomization, then the screening FibroScan® does not need to be repeated., Central laboratory tests at screening or pre-baseline that meet all of the following criteria: a. Estimated glomerular filtration rate (eGFR) = 15 mL/min (> 30 mL/min in the Republic of Korea), as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at Screening; b. Hemoglobin A1c (HbA1c) = 9.5% at Screening; c. International Normalized Ratio (INR) < 1.3 at Screening, unless due to therapeutic anticoagulation; d. Total bilirubin < 1.3 mg/dL at Screening and Pre-baseline and direct bilirubin = 0.5 mg/dL at Screening. For subjects with Gilbert’s syndrome or hemolytic anemia, total bilirubin may be elevated if direct bilirubin = ULN; e. Creatine kinase (CK) < 3 × upper limit of normal (ULN) at Screening; f. Platelet count = 100,000/µL at Screening; g. Triglyceride (TG) level = 500 mg/dL at Screening; h. Aspartate aminotransferase (AST) > 17 for females and > 20 for males at Screening and Pre-baseline; Note: The AST inclusion criteria does not apply to subjects with an eligible historical liver biopsy performed = 180 days prior to randomization with confirmed fibrosis stage 2-3 and NAS = 4. i. AST = 5 × ULN at Screening and Pre-baseline; j. Alanine aminotransferase (ALT) = 5 × ULN at Screening and Prebaseline; k. Alkaline phosphatase (ALP) < 2 × ULN at Screening and Prebaseline; l. 25-Hydroxy Vitamin D = 20 ng/mL at Screening. Note: Laboratory tests for eligibility assessment may be repeated one time at the Investigator’s discretion., Documented stability of ALT and AST levels, as evidenced by no significant worsening of ALT and AST values at pre-baseline relative to screening values and the following parameters: a. If the screening and pre-baseline ALT and AST values are both = 1.5 × ULN, there is no limit to the difference between the values. b. If at least 1 of the screening or pre-baseline ALT or AST values is > 1.5 × ULN and shows worsening at pre-baseline, the percent increase must be = 50%. Note: Subjects must have ALT and AST repeated during the screening period (Pre-Baseline visit) at minimum 28 days between blood draws to confirm either criterion 6a or 6b above. Laboratory tests for eligibility assessment may
排除标准
- •Presence of cirrhosis on liver biopsy (stage 4 fibrosis)., History of pancreatitis., Chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive) or acute hepatitis A infection (hepatitis A immunoglobulin M [IgM] antibody positive). For subjects with positive hepatitis B core antibody (HBcAb), HBV DNA by quantitative polymerase chain reaction (PCR) will be required., Chronic hepatitis C virus (HCV) infection (HCV antibody [Ab] and HCV RNA positive). Subjects cured of HCV infection < 2 years prior to the Screening visit (based on date of RNA PCR negative confirmation following conclusion of treatment) are not eligible., Prior (< 2 years prior to screening) or planned (during the study period) bariatric surgery (e.g., gastroplasty, Roux-en-Y gastric bypass) or reversal or removal of intragastric balloon. Surgery failure < 2 years prior to screening is also exclusionary., Other causes of liver disease based on medical history and/or centralized review of liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis [PBC], primary sclerosing cholangitis [PSC], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, or clinically significant iron overload., History of liver transplantation., Current or prior history of hepatocellular carcinoma (HCC)., Current diagnosis of Cushing’s syndrome., History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening; Note: Significant alcohol consumption is defined as an average exceeding 1 ethanol containing drink/day in female subjects and 2 ethanol containing drinks/day in male subjects., Human immunodeficiency virus (HIV) infection., Weight loss > 10% within 90 days prior to the collection date of the liver biopsy specimen used to assess subject eligibility., Uncontrolled cardiac arrhythmia or confirmed QT interval corrected using Fridericia’s formula (QTcF) > 450 msec for males and > 470 msec for females at the screening electrocardiogram (ECG) assessment. Subjects with cardiac pacemakers and elevated QTcF (> 450 msec for males and > 470 msec for females) may be allowed to participate if, in the Investigator’s opinion, the subject’s cardiac function is stable. Note: ECG for eligibility assessment may be repeated one time at the Investigator’s discretion, Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 90 days prior to screening., Life expectancy of less than 2 years., Use of any investigational medication within 30 days or 5 half lives, whichever is longer, prior to screening or concurrent participation in another therapeutic clinical study., Use of any prohibited medication(s) as outlined in Table 2 of the protocol including any prior exposure to EFX., Positive urine drug screen for amphetamines, cocaine, or opiates (e.g., heroin, morphine) at screening. Subjects with a positive urine drug screen due to prescription medication (e.g., opiates, methylphenidate) are eligible if the prescription and diagnosis are reviewed and approved by the Investigator. Subjects on stable methadone or buprenorphine maintenance treatment for at least 180 days prior to screening may be included in the study., Unable to safely undergo a liver biopsy., Presence of any laboratory abnormality or significant systemic or major illnesses (other than liver
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