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Clinical Trials List

Protocol NumberPOLARIS2023-001
NCT Number(ClinicalTrials.gov Identfier)NCT05842512
Active

2023-02-01 - 2028-01-31

Phase II

Not yet recruiting6

Recruiting4

ICD-10K74.4

Secondary biliary cirrhosis

ICD-10K75.81

Nonalcoholic steatohepatitis (NASH)

ICD-10K76.0

Fatty (change of) liver, not elsewhere classified

ICD-10K76.89

Other specified diseases of liver

ICD-10R16.2

Hepatomegaly with splenomegaly, not elsewhere classified

ICD-9571.8

Other chronic nonalcoholic liver disease

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of ADI-PEG 20 or Placebo in Subjects With Nonalcoholic Steatohepatitis (NASH)

  • Sponsor

  • Trial scale

    Taiwan Multiple Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 張明鈴 醫師 Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 盧勝男 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳立偉 醫師 Digestive System Department
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張吉仰 醫師 Digestive System Department
Fu Jen Catholic University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 許耀峻 醫師 Digestive System Department
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chun-Jen Liu Digestive System Department
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ming-Lung Yu Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 陳啟益 醫師 Digestive System Department
Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yi-Hsiang Huang Division of Family Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Pin-Nan Cheng Digestive System Department
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Nonalcoholic Steatohepatitis (NASH)

Objectives

1. The main research purposes of the test are: •Using magnetic resonance imaging-proton density fat fraction (MRI-PDFF) to evaluate the absolute change in liver fat between baseline and week 24 2. The secondary research purposes of the test are: • MRI-PDFF was used to evaluate the percentage change of liver fat between baseline and week 24 •Evaluation responders: Refers to subjects who have reached clinical significance at week 24 and have a relative reduction of liver fat content of at least 30% as measured by MRI-PDFF •Responder according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Inflammation Scoring System (NAS): A decrease in NAS of 2 points and a decrease in inflammation or hepatocyte expansion in the liver lobules by at least 1 point, and No subjects with worsening fibrosis Change in •Evaluated Alanine Transamination酶 (ALT)) from Baseline to Week 24 •Assessing the safety and tolerability of ADI-PEG 20 in subjects with NASH 3. The purpose of experimental exploration is to understand: •Changes in markers of liver injury and liver function since baseline, including aspartate transamination (AST), alkaline phosphate (ALP), and proglutamine GGT, Bilirubin, International Normalized Ratio (INR) and Albumin •Changes in weight and waist-to-hip ratio since baseline •Liver fat quantification by MRI-PDFF •Changes in non-invasive plasma (or serum) biomarkers since baseline, including predictors of liver fibrosis (pro-C3)

Test Drug

ADI-PEG 20

Active Ingredient

Arginine deiminase conjugated to polyethylene glycol 20,000 mw

Dosage Form

Injection

Dosage

3.5mL/vial；11.5±1.0mg/mL

Endpoints

1. Main evaluation indicators:
Absolute value changes in liver fat in MRI-proton density fat fraction (MRI-PDFF) between baseline and week 24

2. Secondary evaluation indicators:
(1)Percent change of MRI-PDFF liver fat between baseline and weeks 12 and 24
(2) Responders: Refers to subjects who have reached clinical significance at week 24 and have a relative reduction of liver fat content of at least 30% as measured by MRI-PDFF
(3) Responders according to the non-alcoholic fatty liver disease inflammation scoring system (NAS): NAS is reduced by 2 points, and inflammation in the liver lobules or hepatocyte expansion is reduced by at least 1 point, and there is no worsening of fibrosis subjects
(4) Changes in alanine transamination (ALT) from baseline at weeks 12 and 24
(5) Safety and tolerability of ADI-PEG 20 in NASH subjects

Inclution Criteria

Inclusion Criteria:

Males and non-lactating, pregnancy test negative females between 18 - 80 years of age with biopsy proven F1 - F3 NASH. Limit F1 fibrosis to ≤ 20% of total subject population.
Willingness to use appropriate contraceptive measures though out study treatment and for 90 days thereafter (see Appendix A).
Body mass index (BMI) > 25 kg/m2
Must have confirmation of ≥ 10% liver fat content on MRI-PDFF at screening.
Biopsy-proven NASH. Must have had a liver biopsy within 4 weeks of randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

Steatosis (scored 0 to 3),
Ballooning degeneration (scored 0 to 2), and
Lobular inflammation (scored 0 to 3).
Must have no evidence of worsening of ALT and AST (within 50%) measurements at the screening (-4 weeks) and pre-baseline (-2 weeks) visits.
Screening laboratory parameters, as determined by the central laboratory:

Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft- Gault equation;
HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 µmol if HbA1c is unable to be resulted);
Hemoglobin ≥ 11 g/dL;
INR ≤ 1.3, unless due to therapeutic anticoagulation;
Direct bilirubin ≤ 0.5 mg/dL;
Total bilirubin ≤ 1.3 x upper limit of normal (ULN), unless due to an alternate etiology such as Gilbert's syndrome or hemolytic anemia;
Creatinine kinase < 3 x ULN;
Platelet count ≥ 150,000/µL;
Serum triglyceride level ≤ 500 mg/dL;
ALT < 5 x ULN;
AST < 5 x ULN;
ALP < 2 x ULN.
FibroScan® measurement > 7.0 kPa
Subjects on non-insulin dependent diabetic, weight loss, or lipid-modifying medication(s) must be on stable dose(s) for at least 3 months prior to the diagnostic liver biopsy through randomization.

Exclusion Criteria

Exclusion Criteria:

Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening.
Type 1 and insulin-dependent Type 2 diabetes.
Presence of cirrhosis on liver biopsy (stage 4 fibrosis).
Poorly controlled hypertension (blood pressure [BP] > 160/100 mmHg).
Prior history of decompensated liver disease including ascites, hepatic encephalopathy (HE), or variceal bleeding.
Chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive).
Chronic hepatitis C virus (HCV) infection (HCV antibody [Ab] and HCV ribonucleic acid [RNA] positive). Subjects cured of HCV infection less than 2 years prior (based on date of RNA polymerase chain reaction [PCR] negative confirmation following conclusion of treatment) to the screening visit are not eligible.
Prior or planned (during the study period) bariatric surgery (e.g., gastroplasty, roux-en-Y gastric bypass), surgery reversal or removal of intragastric balloon > 2 years prior to enrollment would be eligible.
Other causes of liver disease based on medical history and/or centralized review of liver histology, 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, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment.
History of liver transplantation.
Current or prior history of hepatocellular carcinoma (HCC).
Alcohol intake above an average limit of 2 drinks per day for women and 3 drinks per day for men.
Human immunodeficiency virus (HIV) infection.
Unstable cardiovascular disease in the 6 months prior to screening.
Life expectancy less than 2 years.
Use of any investigational medication within 30 days or within 5 half-lives of the investigational medication, whichever is longer, prior to screening and throughout the study is prohibited.
Subjects with a history of (12 months prior to screening) or current use of prescription drugs associated with liver steatosis (e.g. methotrexate, amiodarone, high-dose estrogen, tamoxifen, systemic steroids, anabolic steroids, valproic acid) should be excluded.

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    60 participants

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