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Compares treatment options for Nonalcoholic Steatohepatitis (NASH)
Official title Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
ClinicalTrials.gov ID: NCT05842512
What this study is testing
What is ADI-PEG20?
ADI-PEG20 is an investigational medicine, being studied as a potential treatment for nonalcoholic steatohepatitis (nash).
Also referred to as Pegargiminase.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Males and non-lactating, pregnancy test negative females between 18 - 80 years of age with biopsy proven F1 - F4 (compensated cirrhosis, Child-Pugh...
- Willingness to use appropriate contraceptive measures throughout study treatment and for 90 days thereafter (see Appendix A).
- Body mass index (BMI) \> 23 kg/m2
- Must have confirmation of ≥ 5 % liver fat content on MRI-PDFF at screening.
- Biopsy-proven NASH confirmed by a central pathologist. Must have had a liver biopsy either during the screening period or a historical biopsy...
You likely can't join if
- 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.
- 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). people cured of HCV infection less than 1 year...
See the full eligibility criteria
- Males and non-lactating, pregnancy test negative females between 18 - 80 years of age with biopsy proven F1 - F4 (compensated cirrhosis, Child-Pugh A, score ≤6) NASH. Limit F1 fibrosis to ≤ 20% of total subject...
- Willingness to use appropriate contraceptive measures throughout study treatment and for 90 days thereafter (see Appendix A).
- Body mass index (BMI) \> 23 kg/m2
- Must have confirmation of ≥ 5 % liver fat content on MRI-PDFF at screening.
- Biopsy-proven NASH confirmed by a central pathologist. Must have had a liver biopsy either during the screening period or a historical biopsy conducted within the last 6 months prior to pre-screening with fibrosis stage...
- 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 within 2 months prior to screening (-8 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 \< 6 x ULN;
- AST \< 6 x ULN;
- ALP \< 2 x ULN.
- FibroScan® measurement \> 7.0 kPa and \< 20.0 kPa.
- people 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.
- people on vitamin E and pioglitazone must maintain a stable dosage before the diagnostic liver biopsy and during the study period.
- 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.
- 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). people cured of HCV infection less than 1 year prior (based on date of RNA polymerase chain reaction [PCR] negative...
- 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]...
- History of liver transplantation.
- people with primary cancer, including co-existent second malignancy, with the exception of primary solid tumor with no known active disease present in the opinion of the Investigator which will not affect subject...
- Alcohol intake above an average limit of 2 drinks per day for women and 3 drinks per day for men. An alcoholic drink is defined as 12 ounces of regular beer, which is usually about 5% alcohol, 5 ounces of wine, which is...
- 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.
- people with a history of (12 months prior to baseline) or current use of prescription drugs associated with liver steatosis (e.g., methotrexate, amiodarone, high-dose estrogen, tamoxifen, systemic steroids, anabolic...
- Contraindication of magnetic resonance imaging. These include but are not limited to devices or metal foreign bodies, such as Pacemaker, defibrillator or wires other than sternal wires, metallic foreign body in the eye...
- MELD score \>12
- people with esophageal or gastric varices with recent bleeding episodes (within 1 year).
The study team makes the final eligibility decision.
Where it's taking place
- Chiayi City, Taiwan, Taiwan
- Kaohsiung, Taiwan, Taiwan
- Keelung, Taiwan, Taiwan
- Tainan, Taiwan, Taiwan
- Taipei, Taiwan, Taiwan
- Taoyuan, Taiwan, Taiwan
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chiayi City, Taiwan, Taiwan; Kaohsiung, Taiwan, Taiwan; Keelung, Taiwan, Taiwan; Tainan, Taiwan, Taiwan; Taipei, Taiwan, Taiwan; Taoyuan, Taiwan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.