Actively Recruiting
A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of ADI-PEG 20 or Placebo in Subjects With Nonalcoholic Steatohepatitis (NASH)
Led by Polaris Group · Updated on 2025-09-23
60
Participants Needed
10
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ADI-PEG 20 in adults with Nonalcoholic Steatohepatitis (NASH), a liver condition characterized by fat buildup and inflammation. This phase 2A clinical trial compares ADI-PEG 20 with a placebo to understand its impact on liver fat reduction. The study includes careful monitoring of side effects and laboratory tests to ensure participant safety. Participants receive weekly doses of ADI-PEG 20 or placebo via intramuscular injection at 36 mg/m2. The trial is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts 24 weeks, during which liver fat changes are assessed using MRI-PDFF imaging. An independent committee oversees safety by reviewing adverse events and clinical data. During the study, participants undergo regular health evaluations including vital signs, body weight checks, ECGs, and blood tests. Liver fat levels are measured at the start and at week 24 to assess treatment effects. Safety is monitored continuously through adverse event reporting and laboratory tests. The total participation time spans 24 weeks, with ongoing review of safety and efficacy outcomes throughout.
CONDITIONS
Brief Title
Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and non-lactating, pregnancy test negative females between 18 and 80 years of age with biopsy-proven NASH fibrosis stage F1 to F4
- Willingness to use appropriate contraceptive measures during treatment and for 90 days after
- Body mass index (BMI) greater than 23 kg/m2
- Confirmation of at least 5% liver fat content on MRI-PDFF at screening
- Biopsy-proven NASH with a NAFLD activity score of 4 or higher including specified components
- No worsening of ALT and AST measurements within 50% in the 2 months prior to screening
- Screening lab parameters within specified limits including eGFR, HbA1c, hemoglobin, INR, bilirubin, creatinine kinase, platelets, triglycerides, ALT, AST, and ALP
- FibroScan measurement greater than 7.0 kPa and less than 20.0 kPa
- Stable doses of certain diabetic, weight loss, or lipid-modifying medications for at least 3 months prior to biopsy
- Stable dosage of vitamin E and pioglitazone before biopsy and during the study period
You will not qualify if you...
- Weight change greater than 5% in the 3 months prior to randomization or greater than 10% in the 6 months prior to screening
- Type 1 diabetes or insulin-dependent Type 2 diabetes
- Poorly controlled hypertension (BP over 160/100 mmHg)
- History of decompensated liver disease such as ascites or variceal bleeding
- Chronic hepatitis B or C infection
- Prior or planned bariatric surgery within 2 years
- Other liver diseases including autoimmune disorders and drug-induced hepatotoxicity
- History of liver transplantation
- Active or recent cancer except certain solid tumors without active disease
- Excessive alcohol intake above defined daily limits
- HIV infection
- Unstable cardiovascular disease within 6 months prior to screening
- Life expectancy less than 2 years
- Use of investigational medication within 30 days or 5 half-lives prior to screening
- Current or recent use of prescription drugs associated with liver steatosis
- Contraindications to MRI including certain implants or devices
- MELD score over 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive weekly intramuscular injections of ADI-PEG 20 or placebo for NASH over the course of the study.
Weekly visits for treatment and assessments
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
Research Team
S
Silvia Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here