A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis
NCT ID: NCT05402371
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2022-10-15
2025-09-30
Brief Summary
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Detailed Description
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This study consists of 3 phases: (i) Screening and Randomization; (ii) treatment; and (iii) follow up. During Screening, each subject will provide informed consent prior to starting any study specific procedures. The randomization of the F2/F3 NASH subjects will be performed in a 1:1:1:1 ratio between Rencofilstat 75mg, Rencofilstat 150mg, Rencofilstat 225mg, and matching placebo. Subjects will be stratified by presence or absence of Type 2 diabetes, fibrosis stage and a maximum of 34 F2 subjects in each cohort.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort A: Rencofilstat 75 mg
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 75 mg daily.
Rencofilstat
Rencofilstat soft gel capsule
Cohort B: Rencofilstat 150 mg
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 150 mg daily.
Rencofilstat
Rencofilstat soft gel capsule
Cohort C: Rencofilstat 225 mg
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 225 mg daily.
Rencofilstat
Rencofilstat soft gel capsule
Cohort D: Placebo
Eighty-four (84) biopsy-proven NASH F2 / F3 subjects to complete study on matching placebo.
Placebo
placebo soft gel capsule
Interventions
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Rencofilstat
Rencofilstat soft gel capsule
Placebo
placebo soft gel capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.
3. Histologic evidence of NASH based on central readings of the screening biopsy obtained no more than 6 months before Screening defined by presence of all 3 key histological features, Nonalcoholic Fatty Liver Disease Activity Score (NAS) ≥ 4 with at least 1 point each in lobular inflammation and hepatocyte ballooning.
a. Historical biopsy may be substituted for Screening biopsy to determine eligibility if the following are met: i. Historical biopsy was obtained no more than 180 ± 5 days prior to the first day of Screening.
ii. Hepatic tissue or slides are available for central histologic evaluation. iii. No new therapeutic intervention for NASH was made 90 days prior to screening (e.g., obeticholic acid, vitamin E ≥ 400 IU/day, pioglitazone, incretins \[e.g., liraglutide, semaglutide\], sodium-glucose cotransporter-2 \[SGLT2\] inhibitors).
iv. Subjects must have been metabolically stable since the biopsy (no significant weight loss ≥ 7% of body weight, no major deterioration of glycemic control, and no introduction of new or investigational drugs for the treatment of Type 2 Diabetes).
4. Histologic liver fibrosis stage 2 or 3 as defined by the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) scoring of liver fibrosis based on central reading of the Screening biopsy (refer to criteria 4a regarding use of a historical biopsy as a substitute for the Screening biopsy).
5. Blood pressure up to 160/100 mmHg; potential subjects who meet other eligibility requirements, but who have out of range blood pressure measurements deemed to be not clinically significant by the investigator, may still be considered for study inclusion.
4. Subjects with suspected and symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection identified prior to first dose.
5. Subjects with a history of clinically significant acute cardiac events within 30 days prior to Screening such as stroke, transient ischemic attack, or coronary heart disease (angina pectoris requiring therapy, myocardial infarction, revascularization procedures with left ventricular ejection fraction \[LVEF\] \<50% as determined by previous echocardiography or multiple gated acquisition \[MUGA\] scan).
6. Subjects with uncontrolled or unstable cardiac arrhythmias:
1. Severe conduction disturbance (e.g., second-degree or third-degree AV block).
2. History of congenital long QT syndrome, congenital short QT syndrome, Torsades de Pointes, or Wolff Parkinson White syndrome.
7. Subjects with transaminases \>5 x upper limit of normal (ULN).
8. Subjects with ALP \>2 x ULN.
9. Subjects with total serum bilirubin \>1.5 x ULN.
10. Subjects with a platelet count \<100,000/mm3.
11. Subjects with an INR ≥ 1.3 in the absence of anticoagulants.
12. Subjects with albumin \<3.5 g/dL.
13. Model for End-Stage Liver Disease (MELD) score \>12, unless due to an alternate etiology such as therapeutic anticoagulation.
14. Current or previous (within the past 6 months) Child-Pugh (CP) score ≥ 7 for F2 or F3 subjects, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation.
15. An estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] method).
16. Subjects with hemoglobin A1c (HbA1c) \>9.5%.
17. Subjects with any history or presence of decompensated cirrhosis including ascites, hepatic encephalopathy or variceal bleeding.
18. Other well documented causes of chronic liver disease according to standard diagnostic procedures including, but not restricted to:
1. Suspicion of drug-induced liver disease.
2. Alcoholic liver disease.
3. Autoimmune hepatitis.
4. Wilson's disease.
5. Primary biliary cholangitis, primary sclerosing cholangitis.
6. Genetic hemochromatosis (Homozygosity for C282Y or C282Y/H63D compound heterozygote).
7. Known or suspected hepatocellular carcinoma (HCC).
8. History or planned liver transplant.
9. Clinical evidence of portal hypertension such as esophageal varices, ascites, history of hepatic encephalopathy, or splenomegaly.
19. History of hepatic decompensating events or subjects who develop manifestations of hepatic decompensation between screening and enrollment should not be randomized, inclusive of new or worsening jaundice and ascites, new esophageal varices, etc.
20. Subjects with Type 2 diabetes who have recent (\< 3 months) changes in medication class or dose of the following antidiabetic medications: Glucagon-like-peptide-1 (GLP-1) receptor agonist, dipeptidyl peptidase-4 (DPP-4) inhibitor, sodium/glucose cotransporter 2 (SGLT2) inhibitor, thiazolidinediones (TZD).
21. Received an investigational drug or investigational vaccine or used an investigational medical device within 60 days prior to first dose of study drug.
22. Received any investigation products being evaluated for the treatment of liver fibrosis or NASH in the 6 months prior to the Screening liver biopsy.
23. Inability to undergo MRE procedure due to unremovable metal or foreign object(s) or contraindication for any other reason including but not limited to pacemaker, shrapnel injury, extensive tattoos, severe claustrophobia, ear (cochlea) implant.
Exclusion Criteria
2. Known allergy to Rencofilstat, cyclosporine, or any of their inactive ingredients.
18 Years
75 Years
ALL
No
Sponsors
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Hepion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Harrison, MD
Role: PRINCIPAL_INVESTIGATOR
Pinnacle Clinical Research
Locations
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Medical Affiliated Research Center
Huntsville, Alabama, United States
Arizona Liver Health-Chandler
Chandler, Arizona, United States
Arizona Liver Health
Peoria, Arizona, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
Arizona Liver Health-Tuscon
Tucson, Arizona, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
National Research Institute
Huntington Park, California, United States
National Research Institute
Los Angeles, California, United States
National Research Institute
Panorama City, California, United States
National Research Institute
Santa Ana, California, United States
Synergy Healthcare, LLC
Bradenton, Florida, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States
Top Medical Research, Inc.
Cutler Bay, Florida, United States
Integrity Clinical Research, LLC
Doral, Florida, United States
Evolution Clinical Trials, Inc.
Hialeah Gardens, Florida, United States
Borland Groover Clinical Research
Jacksonville, Florida, United States
Ocala GI Research
Lady Lake, Florida, United States
Accel Research Sites-Lakeland CRU
Lakeland, Florida, United States
Future Care Solutions, LLC
Miami, Florida, United States
Entrust Clinical Research
Miami, Florida, United States
United Reseach Group
Miami, Florida, United States
Omega Research Consultants, LLC
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Covenant Research and Clinics
Sarasota, Florida, United States
Southeast Clinical Research Center
Dalton, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Digestive Research Alliance of Michiana, LLC
South Bend, Indiana, United States
Delta Research Partners
Bastrop, Louisiana, United States
Mid-Atlantic GI Research, LLC
Greenbelt, Maryland, United States
AIG Digestive Disease Research, LLC
Florham Park, New Jersey, United States
Pinnacle Clinical Research-Austin
Austin, Texas, United States
South Texas Research Institute
Brownsville, Texas, United States
South Texas Research Institute
Edinburg, Texas, United States
LinQ Research, LLC
Pearland, Texas, United States
Pinnacle Clinical Research-San Antonio
San Antonio, Texas, United States
Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States
GI Select Health Research, LLC
Richmond, Virginia, United States
Velocity Clinical Spokane
Spokane, Washington, United States
Hopital du Haut Leveque
Pessac, , France
Centro de Investigacion y Gastroenterologia SC
Mexico City, , Mexico
Countries
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Other Identifiers
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HEPA-CRV431-207
Identifier Type: -
Identifier Source: org_study_id
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