此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Saroglitazar 镁治疗非酒精性脂肪性肝炎伴纤维化 (NASH)

2026年9月9日 更新者：Zydus Therapeutics Inc.

一项 2b 期、前瞻性、多中心、随机、双盲、安慰剂对照研究，旨在评估 Saroglitazar 镁对非酒精性脂肪性肝炎和纤维化患者的疗效和安全性

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

研究概览

地位

完全的

条件

干预/治疗

详细说明

A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis.

研究类型

介入性

注册 (实际的)

189

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
      • Adana、土耳其（türkiye）、01240
        • Zydus TR003
      • Ankara、土耳其（türkiye）、06230
        • Zydus TR002
      • Ankara、土耳其（türkiye）、06800
        • Zydus TR001
      • Bursa、土耳其（türkiye）、16059
        • Zydus TR004
      • Gaziantep、土耳其（türkiye）、27310
        • Zydus TR005
      • Istanbul、土耳其（türkiye）、34093
        • Zydus TR009
      • Istanbul、土耳其（türkiye）、34760
        • Zydus TR008
      • Izmir、土耳其（türkiye）、35100
        • Zydus TR007
      • Izmir、土耳其（türkiye）、35150
        • Zydus TR006
      • Kayseri、土耳其（türkiye）、38039
        • Zydus TR011
      • Kocaeli、土耳其（türkiye）、41000
        • Zydus TR010
      • Mersin、土耳其（türkiye）、33110
        • Zydus TR012
      • Rize、土耳其（türkiye）、53020
        • Zydus TR013
      • Trabzon、土耳其（türkiye）、61080
        • Zydus TR014
  • 波多黎各
    • Puerto Rico
      • San Juan、Puerto Rico、波多黎各、00927
        • Zydus US097
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • Zydus US032
      • Homewood、Alabama、美国、35209
        • Zydus US079
    • Arizona
      • Phoenix、Arizona、美国、85013
        • Zydus US047
      • Tucson、Arizona、美国、85712
        • Zydus US025
      • Tucson、Arizona、美国、85712
        • Zydus US087
      • Tucson、Arizona、美国、85724
        • Zydus US029
    • California
      • Chula Vista、California、美国、91911
        • Zydus US118
      • Fresno、California、美国、93720
        • Zydus US041
      • Gardena、California、美国、90247
        • Zydus US111
      • Huntington Park、California、美国、90255
        • Zydus US013
      • La Jolla、California、美国、92037
        • Zydus US065
      • Lancaster、California、美国、93534
        • Zydus US094
      • Long Beach、California、美国、90808
        • Zydus US080
      • Long Beach、California、美国、90815
        • Zydus US090
      • Los Angeles、California、美国、90027
        • Zydus US022
      • Los Angeles、California、美国、90033
        • Zydus US062
      • Murrieta、California、美国、92563
        • Zydus US023
      • Orange、California、美国、92868
        • Zydus US052
      • Panorama City、California、美国、91402
        • Zydus US012
    • Colorado
      • Aurora、Colorado、美国、80045
        • Zydus US039
    • Florida
      • Clearwater、Florida、美国、33761
        • Zydus US122
      • Fort Myers、Florida、美国、33907
        • Zydus US057
      • Hallandale、Florida、美国、33009
        • Zydus US108
      • Hialeah Gardens、Florida、美国、33016
        • Zydus US096
      • Lakeland、Florida、美国、33803
        • Zydus US003
      • Lakewood Rch、Florida、美国、34211
        • Zydus US016
      • Largo、Florida、美国、33777
        • Zydus US125
      • Maitland、Florida、美国、32751
        • Zydus US001
      • Maitland、Florida、美国、32751
        • Zydus US124
      • Miami、Florida、美国、33014
        • Zydus US007
      • Miami、Florida、美国、33135
        • Zydus US024
      • Miami、Florida、美国、33136
        • Zydus US034
      • Miami、Florida、美国、33136
        • Zydus US038
      • Miami、Florida、美国、33155
        • Zydus US121
      • Miami、Florida、美国、33173
        • Zydus US054
      • Miami Lakes、Florida、美国、33016
        • Zydus US098
      • Naples、Florida、美国、34102
        • Zydus US099
      • Ocala、Florida、美国、34471
        • Zydus US081
      • Orlando、Florida、美国、32806
        • Zydus US085
      • Port Orange、Florida、美国、32127
        • Zydus US104
      • Winter Park、Florida、美国、32789
        • Zydus US004
    • Georgia
      • Dalton、Georgia、美国、30720
        • Zydus US107
      • Gainesville、Georgia、美国、30501
        • Zydus US113
      • Marietta、Georgia、美国、30060
        • Zydus US114
      • Savannah、Georgia、美国、31406
        • Zydus US119
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Zydus US020
    • Iowa
      • West Des Moines、Iowa、美国、50652
        • Zydus US100
    • Kansas
      • Kansas City、Kansas、美国、66160
        • Zydus US049
    • Louisiana
      • Houma、Louisiana、美国、70363
        • Zydus US071
      • Marrero、Louisiana、美国、70072
        • Zydus US014
      • West Monroe、Louisiana、美国、71291
        • Zydus US123
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Zydus US017
    • Michigan
      • Chesterfield、Michigan、美国、48047
        • Zydus US092
      • Wyoming、Michigan、美国、49519
        • Zydus US019
    • Minnesota
      • Saint Paul、Minnesota、美国、55101
        • Zydus US115
    • Missouri
      • Columbia、Missouri、美国、65201
        • Zydus US074
      • Kansas City、Missouri、美国、64131
        • Zydus US120
    • Nevada
      • Reno、Nevada、美国、89511
        • Zydus US116
    • New Jersey
      • Sparta、New Jersey、美国、07871
        • Zydus US077
    • New York
      • Manhasset、New York、美国、11030
        • Zydus US069
      • New York、New York、美国、10033
        • Zydus US066
    • North Carolina
      • Asheville、North Carolina、美国、28801
        • Zydus US018
      • Charlotte、North Carolina、美国、28204
        • Zydus US027
    • Ohio
      • Cincinnati、Ohio、美国、45044
        • Zydus US010
      • Cincinnati、Ohio、美国、45267-0595
        • Zydus US009
      • Cleveland、Ohio、美国、44109
        • Zydus US035
      • Springboro、Ohio、美国、45066
        • Zydus US072
    • Pennsylvania
      • Hershey、Pennsylvania、美国、17033
        • Zydus US060
      • Philadelphia、Pennsylvania、美国、19141
        • Zydus US053
    • South Carolina
      • Charleston、South Carolina、美国、29401
        • Zydus US015
      • Charleston、South Carolina、美国、29425
        • Zydus US030
      • Columbia、South Carolina、美国、29204
        • Zydus US073
      • Greenwood、South Carolina、美国、29646
        • Zydus US075
      • Summerville、South Carolina、美国、29485
        • Zydus US112
    • Tennessee
      • Hermitage、Tennessee、美国、37067
        • Zydus US011
      • Nashville、Tennessee、美国、37232
        • Zydus US028
    • Texas
      • Arlington、Texas、美国、76012
        • Zydus US002
      • Austin、Texas、美国、78745
        • Zydus US051
      • Austin、Texas、美国、78757
        • Zydus US101
      • Bellaire、Texas、美国、77401
        • Zydus US089
      • Brownsville、Texas、美国、78520
        • Zydus US105
      • Edinburg、Texas、美国、78539
        • Zydus US095
      • Edinburg、Texas、美国、78539
        • Zydus US106
      • Fort Worth、Texas、美国、76104
        • Zydus US061
      • Houston、Texas、美国、77030
        • Zydus US067
      • Houston、Texas、美国、77030
        • Zydus US109
      • Houston、Texas、美国、77058
        • Zydus US005
      • Houston、Texas、美国、77079
        • Zydus US110
      • Katy、Texas、美国、77084
        • Zydus US117
      • San Antonio、Texas、美国、78215
        • Zydus US031
      • San Antonio、Texas、美国、78222
        • Zydus US103
      • San Antonio、Texas、美国、78229
        • Zydus US036
      • San Antonio、Texas、美国、78229
        • Zydus US102
      • San Antonio、Texas、美国、78234
        • Zydus US043
      • San Antonio、Texas、美国、78240
        • Zydus US008
      • Waco、Texas、美国、76712
        • Zydus US078
      • Wichita Falls、Texas、美国、76301
        • Zydus US076
    • Utah
      • Ogden、Utah、美国、84405
        • Zydus US088
    • Virginia
      • Manassas、Virginia、美国、20110
        • Zydus US070
      • Richmond、Virginia、美国、23236
        • Zydus US082
      • Richmond、Virginia、美国、23298
        • Zydus US021
  • 阿根廷
      • Buenos Aires、阿根廷、B1629ODT
        • Zydus AR004
      • CABA、阿根廷、C1056ABJ
        • Zydus AR001
      • CABA、阿根廷、C1180AAX
        • Zydus AR013
      • CABA、阿根廷、C1199ABB
        • Zydus AR007
      • CABA、阿根廷、C1221ADC
        • Zydus AR006
      • CABA、阿根廷、C1264AAA
        • Zydus AR005
      • CABA、阿根廷、C1425AGC
        • Zydus AR008
      • CABA、阿根廷、C1426ABP
        • Zydus AR012
      • CABA、阿根廷、CP143CKE
        • Zydus AR003
      • Mar del Plata、阿根廷、B7600
        • Zydus AR009
      • Mar del Plata、阿根廷
        • Zydus AR011
      • Ramos Mejía、阿根廷
        • Zydus AR002
      • Rosario、阿根廷、S2002KDS
        • Zydus AR010

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Males or females, between 18 and 75 years of age, both inclusive at screening.
  • BMI ≤45 kg/m²
  • Histological confirmation of NASH with liver fibrosis by central pathologist on a diagnostic liver biopsy with a NAS ≥4 with at least one-point score in each of the three components of the NAFLD activity score [NAS] (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3) and NASH by pattern recognition Note: The biopsy must not have been performed more than 24 weeks before randomization.
  • The subjects must have a stable body weight (no more than 5% change) between the time of biopsy and randomization.
  • Fibrosis stage 2 and 3, according to the NASH CRN fibrosis staging, reported by central pathologist.
  • If the subjects have type 2 diabetes mellitus, then it must be moderately controlled with HbA1c ≤ 9.5% and on a stable dose of permitted anti-diabetic medication for at least 90 days before screening until randomization.
  • If the subjects are taking vitamin E > 400 IU/day, then it must be on a stable dose for at least 24 weeks prior to screening or, if a historical biopsy is used, at least 24 weeks prior to baseline liver biopsy until randomization.
  • Must provide written informed consent and agree to comply with the trial protocol.

Exclusion Criteria:

  • Consumption of >2 units of alcohol per day (>14 units per week) if male and >1 units of alcohol per day (>7 units per week) if female for at least 12 consecutive weeks within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor)

  • History or presence of other concomitant liver diseases at screening:

    1. Chronic hepatitis B (HBV) or hepatitis C virus (HCV) infection (However, If the subject has been treated for the HCV infection and has been cured at least 5 years from screening, such subjects can be enrolled in the study)
    2. Primary biliary cholangitis (PBC)
    3. Primary sclerosing cholangitis (PSC)
    4. Definite autoimmune liver disease or overlap syndrome
    5. Alcoholic liver disease
    6. Hemochromatosis
    7. Wilsons disease
    8. Alpha-1 antitrypsin deficiency

  • Subject with known cirrhosis, either based on histology, clinical criteria or any non-invasive diagnostic modality, within 24 weeks prior to the randomization.

  • Evidence of portal hypertension (low platelet count, esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly) at screening.

  • Treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs), sodium glucose cotransporter- 2 (SGLT-2) inhibitors, and dipeptidyl peptidase 4 inhibitors (gliptins) unless stable for 120 days prior to screening or, if a historical biopsy is used, from 120 days prior to baseline liver biopsy until randomization.

  • Use of concurrent medications prior to screening including:

    1. Anti-NASH therapy(s) including S-adenosyl methionine (SAMe), ursodeoxycholic acid (UDCA), and obeticholic acid in the period from 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until randomization. For resmetirom; 120 days prior to screening or if a historical biopsy is used, from 120 days prior to baseline liver biopsy until randomization.
    2. Antidiabetic mediation which may impact NASH histology including thiazolidinediones (pioglitazone, rosiglitazone) in the period from 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until randomization.
    3. Immune modulatory agents including anti-TNF-α therapies (infliximab, adalimumab, etanercept) or anti-integrin therapy (namixilab) in the period from 28 days prior to screening or if a historical biopsy is used from 28 days prior to baseline liver biopsy until randomization.
    4. Any treatment or anticipated initiation (intended use for more than 14 consecutive days) of medications known to have an effect on steatosis (e.g. treatment with corticosteroids [topical and inhaled are allowed]), methotrexate, tamoxifen, valproic acid, amiodarone or tetracycline, estrogens in doses higher than used in oral contraceptives, vitamin A, L-asparaginase, valproate, chloroquine, or antiretroviral drugs in the period from 28 days prior to screening or, if a historical biopsy is used, from 28 days prior to baseline liver biopsy until randomization.
    5. Treatment with orlistat, zonisamide, topiramate, phentermine, lorcaserin, bupropion, or naltrexone alone, or in combination or any other medication, that could promote weight loss, in the opinion of the investigator, in the period from 28 days prior to screening or if a historical biopsy is used from 28 days prior to baseline liver biopsy until randomization.

  • Changing doses of statins (simvastatin, pitavastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, Fenofibrate) in the 90 days preceding screening until randomization.

  • Use of drugs that are known CYP2C8 inhibitors/substrate in the 28 days preceding screening until randomization.

  • History of liver transplant

  • Any weight reduction surgery in the 2 years prior to screening or planned during the study (weight reduction surgery is disallowed during the study), and malabsorptive weight loss surgery (Rouxen-Y or distal gastric bypass) at any time prior to screening.

Note: Lap banding, if the band has been removed >6 months before baseline liver biopsy, or intragastric balloon, if the balloon has been removed > 6 months before baseline liver biopsy, is allowed.

  • Type 1 diabetes mellitus

  • History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and/or excretion of orally administered drugs as judged by the investigator.

  • Unstable cardiovascular disease, including:

    1. unstable angina, (i.e., new or worsening symptoms of coronary heart disease) in the 90 days before screening and throughout the screening period; acute coronary syndrome in the 24 weeks before screening and throughout the screening period;
    2. acute myocardial infarction in the 90 days before screening and throughout the screening period; or heart failure of New York Heart Association class (III - IV), worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the screening period.
    3. history of unstable cardiac dysrhythmias
    4. uncontrolled hypertension at screening
    5. stroke or transient ischemic attack in the 24 weeks before screening

  • History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 times ULN at screening.

  • For subjects with elevated baseline ALT, AST, or ALP; ALT, AST, or ALP exceeding by more than 50% at Visit 2 reading compared to Visit 1 Note: If the ALT, AST or ALP values at Visit 2 exceed by more than 50% from Visit 1, then a third value will be measured to assess for the trend. If the third value shows continued increase ≥ 10%, then subject is considered ineligible for randomization.

  • Any of the following laboratory values at screening:

    1. Hemoglobin <9 g/dL
    2. WBC count <2.5 × 103/µL
    3. Neutrophil count <1.5 × 103/µL
    4. Platelets <140 × 103/µL [if low platelet count is due to reasons other than liver disease as assessed by a hematologist, participants may be eligible if the platelet count is > 75 x 103/µL] as per investigator's discretion]
    5. INR ≥ 1.3 (in the absence of anticoagulants)
    6. Total bilirubin > ULN except in Gilbert's syndrome. In subjects with known Gilbert's syndrome, direct bilirubin > 2 x ULN
    7. Albumin <3.5 g/dL
    8. eGFR <60 mL/min/1.73 m2
    9. ALP ≥ 2x ULN
    10. ALT or AST ≥ 250 U/L

  • Participation in any other therapeutic clinical study and on active treatment in the past 90 days of the screening.

  • History of benign or malignant bladder tumors, and/or hematuria or has current hematuria except due to a urinary tract infection.

  • History of malignancy in the past 5 years and/or active neoplasm with the exception of resolved superficial nonmelanoma skin cancer.

  • Known allergy, sensitivity or intolerance to the study drug, comparator or formulation ingredients.

  • Pregnancy-related exclusions, including:

    1. Pregnant/lactating female (including positive pregnancy test at screening)
    2. Pregnancy should be avoided by male and female participants either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment

  • History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption)

  • Receiving an elemental diet or parenteral nutrition.

  • Chronic pancreatitis or pancreatic insufficiency.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Saroglitazar Magnesium 2 mg

Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
药品：Saroglitazar Magnesium 2 mg

Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.

其他名称：
  • 研究产品
实验性的：Saroglitazar Magnesium 4 mg

Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
药品：Saroglitazar Magnesium 4 mg

Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.

其他名称：
  • 研究产品
安慰剂比较：Placebo

Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
药品：Placebo

Patients randomly assigned to this group will receive Placebo tablet orally once daily in the morning before breakfast without food, for the duration of treatment.

其他名称：
  • 比较剂

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Resolution of steatohepatitis with no worsening of fibrosis
大体时间：52 Weeks/EOT

Resolution of steatohepatitis is defined as absent fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0-1 for inflammation, 0 for ballooning, and any value for Steatosis
52 Weeks/EOT

次要结果测量

结果测量
措施说明
大体时间
Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis
大体时间：Week 52/EOT

Proportion of subjects achieving improvement in liver fibrosis (reduction of at least one stage) with no increase in NAS for ballooning, inflammation or steatosis
Week 52/EOT
2 points improvement in NAS
大体时间：Week 52/EOT

Proportion of subjects with at least 2 points improvement in NAS at Week 52/EOT with at least 1-point improvement in either ballooning or inflammation and no worsening of liver fibrosis
Week 52/EOT
Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy
大体时间：Week 52/EOT

Proportion of subjects with ≥1 point improvement in steatosis, ballooning, inflammation and fibrosis
Week 52/EOT
Decrease in SAF score on liver biopsy
大体时间：Week 52/EOT

Proportion of subjects with decrease in SAF score ≥2 combining hepatocellular inflammation and ballooning without worsening of fibrosis
Week 52/EOT
Histological score changes in steatosis, ballooning, inflammation, and fibrosis
大体时间：Week 52/EOT

Change from baseline in steatosis, ballooning, inflammation, and fibrosis
Week 52/EOT
Change in liver enzyme parameters including (ALT, AST, ALP, GGT, total bilirubin, albumin)
大体时间：Week 52/EOT

Change from baseline in liver enzyme parameters (ALT, AST, ALP, GGT, total bilirubin, albumin)
Week 52/EOT
Change in non-invasive markers of steatosis
大体时间：Week 52/EOT

Change from baseline in non-invasive markers of steatosis (Enhanced Liver Fibrosis [ELF] test, Fibrosis 4 [FIB 4], APRI [AST to Platelet Ratio Index], NFS [NAFLD Fibrosis Score], PRO-C3)
Week 52/EOT
Change in n lipid parameters including (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C
大体时间：Week 52/EOT

Change from baseline in lipid parameters (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C)
Week 52/EOT
Change in body weight (any change from baseline)
大体时间：Week 52/EOT

Change from baseline in body weight
Week 52/EOT
Change in insulin resistance marker, HOMA-IR
大体时间：Week 52/EOT

Change from baseline in insulin resistance marker (HOMA-IR)
Week 52/EOT
Change in inflammatory markers including (CK-18 [M30], IL-6, CRP)
大体时间：Week 52/EOT

Change from baseline in inflammatory markers (CK-18 [M30], IL-6, CRP)
Week 52/EOT
Change in glucose homeostasis markers including (HbA1c, FPG)
大体时间：Week 52/EOT

Change from baseline in glucose homeostasis markers (HbA1c, FPG)
Week 52/EOT

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Zydus Therapeutics Inc.

调查人员

  • 研究主任：Deven V. Parmar, MD, FCP、Zydus Therapeutics Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年8月18日

初级完成 (实际的)

2025年9月12日

研究完成 (实际的)

2025年9月12日

研究注册日期

首次提交

2021年7月11日

首先提交符合 QC 标准的

2021年8月10日

首次发布 (实际的)

2021年8月18日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SARO.20.002

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅