Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT05842512

Study of ADI-PEG 20 Versus Placebo in Subjects With NASH

Led by Polaris Group · Updated on 2025-09-23

60

Participants Needed

10

Research Sites

228 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH

CONDITIONS

Official Title

Study of ADI-PEG 20 Versus Placebo in Subjects With NASH

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and non-lactating, pregnancy test negative females between 18 and 80 years of age with biopsy-proven NASH and fibrosis stages F1 to F4 (compensated cirrhosis, Child-Pugh A, score  6). Limit F1 fibrosis to 20% of subjects.
  • Willingness to use effective contraception during treatment and for 90 days after.
  • Body mass index (BMI) greater than 23 kg/m2.
  • Liver fat content of at least 5% confirmed by MRI-PDFF at screening.
  • Biopsy-proven NASH confirmed by central pathologist with NAS  4 and at least 1 in steatosis, ballooning degeneration, and lobular inflammation.
  • No worsening of ALT and AST by more than 50% within 2 months before screening.
  • Laboratory values within specified limits for eGFR, HbA1c, hemoglobin, INR, bilirubin, creatinine kinase, platelet count, triglycerides, ALT, AST, and ALP.
  • FibroScan measurement between 7.0 and 20.0 kPa.
  • Stable doses of non-insulin diabetic, weight loss, or lipid-modifying medications for at least 3 months before biopsy through randomization.
  • Stable doses of vitamin E and pioglitazone before biopsy and during study.
Not Eligible

You will not qualify if you...

  • Weight change greater than 5% in 3 months or greater than 10% in 6 months before screening.
  • Type 1 diabetes or insulin-dependent Type 2 diabetes.
  • Poorly controlled hypertension (blood pressure above 160/100 mmHg).
  • History of decompensated liver disease including ascites, hepatic encephalopathy, or variceal bleeding.
  • Chronic hepatitis B or hepatitis C infection within 1 year prior.
  • Prior or planned bariatric surgery within 2 years.
  • Other liver diseases such as alcoholic liver disease, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, or alpha-1-antitrypsin deficiency.
  • History of liver transplantation.
  • Current or history of cancer except non-active primary solid tumors.
  • Alcohol intake above 2 drinks/day for women or 3 drinks/day for men.
  • HIV infection.
  • Unstable cardiovascular disease within 6 months.
  • Life expectancy less than 2 years.
  • Use of investigational drugs within 30 days or 5 half-lives before screening.
  • Use of prescription drugs associated with liver steatosis within 12 months prior to baseline.
  • Contraindications to MRI such as pacemaker, metallic foreign bodies, or insulin pumps.
  • MELD score greater than 12.
  • Esophageal or gastric varices with bleeding episodes within 1 year.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Ditmanson Medical Foundation Chiayi Christian Hospital；Chiayi Christian Hospital (CYCH)

Chiayi City, Taiwan, Taiwan, 600566

Actively Recruiting

2

Kaohsiung Medical University Chung-Ho Memorial Hospital(KMUH)

Kaohsiung, Taiwan, Taiwan, 807

Actively Recruiting

3

E-Da Hospital (EDH)

Kaohsiung, Taiwan, Taiwan, 824

Actively Recruiting

4

Chang Gung Medical Foundation-Kaohsiung (CGMF-KS)

Kaohsiung, Taiwan, Taiwan, 833

Actively Recruiting

5

Chang Gung Medical Foundation-Keelung (CGMF-KL)

Keelung, Taiwan, Taiwan, 204

Actively Recruiting

6

National Cheng Kung University Hospital (NCKUH)

Tainan, Taiwan, Taiwan, 704

Actively Recruiting

7

National Taiwan University Hospital (NTUH)

Taipei, Taiwan, Taiwan, 100229

Actively Recruiting

8

Taipei Veterans General Hospital (TPVGH)

Taipei, Taiwan, Taiwan, 112201

Actively Recruiting

9

Fu Jen Catholic University Hospital (FJCUH)

Taipei, Taiwan, Taiwan, 243

Actively Recruiting

10

Chang Gung Medical Foundation-Linkou (CGMF-LK)

Taoyuan, Taiwan, Taiwan, 333

Actively Recruiting

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Research Team

S

Silvia Lee

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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