ASCEND
A Phase 2B, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rencofilstat in Adult Subjects With Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis
Sponsor study identifier
interventional
120
3 countries
41
Study Start
October 15, 2022
Actual (reported)Primary Completion
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 20, 2022
Actual (reported)June 2, 2022
Actual (reported)October 15, 2022
Actual (reported)May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) OR NASH resolution without worsening of fibrosis.
Efficacy
dosing period of 1 year with 1 month observation and follow up period
Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on NASH.
dosing period of 1 year with 1 month observation and follow up period
Proportion of subjects with improvement in fibrosis by at least 2 stages (NASH CRN system), regardless of effect on NASH.
dosing period of 1 year with 1 month observation and follow up period
Proportion of subjects with improvement in fibrosis by at least 2 stages (NASH CRN system) AND no worsening of NASH.
dosing period of 1 year with 1 month observation and follow up period
Change from baseline in ALT.
dosing period of 1 year with 1 month observation and follow up period
Change from baseline in AST.
dosing period of 1 year with 1 month observation and follow up period
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 75 mg daily.
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 150 mg daily.
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 225 mg daily.
Rencofilstat soft gel capsule
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
Arizona Liver Health-Chandler
Chandler, Arizona, 85224, United States
Arizona Liver Health
Peoria, Arizona, 85381, United States
Adobe Clinical Research, LLC
Tucson, Arizona, 85712, United States
Arizona Liver Health-Tuscon
Tucson, Arizona, 85712, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
Stephen Harrison, MD
Pinnacle Clinical Research
120 participants (actual enrollment reported by the registry).
First Submitted
May 20, 2022
First Posted
June 2, 2022
Study Start
October 15, 2022
Actual (reported)Eighty-four (84) biopsy-proven NASH F2 / F3 subjects to complete study on matching placebo.
placebo soft gel capsule
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
National Research Institute
Huntington Park, California, 90255, United States
National Research Institute
Los Angeles, California, 90057, United States
National Research Institute
Panorama City, California, 91402, United States
National Research Institute
Santa Ana, California, 92704, United States
Synergy Healthcare, LLC
Bradenton, Florida, 34208, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761, United States
Top Medical Research, Inc.
Cutler Bay, Florida, 33189, United States
Integrity Clinical Research, LLC
Doral, Florida, 33166, United States
Evolution Clinical Trials, Inc.
Hialeah Gardens, Florida, 33016, United States
Borland Groover Clinical Research
Jacksonville, Florida, 32256, United States
Ocala GI Research
Lady Lake, Florida, 32159, United States
Accel Research Sites-Lakeland CRU
Lakeland, Florida, 33803, United States
Future Care Solutions, LLC
Miami, Florida, 33165, United States
Entrust Clinical Research
Miami, Florida, 33176, United States
United Reseach Group
Miami, Florida, 33186, United States
Omega Research Consultants, LLC
Orlando, Florida, 32810, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Covenant Research and Clinics
Sarasota, Florida, 34240, United States
Southeast Clinical Research Center
Dalton, Georgia, 30720, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Digestive Research Alliance of Michiana, LLC
South Bend, Indiana, 46635, United States
Delta Research Partners
Bastrop, Louisiana, 71220, United States
Mid-Atlantic GI Research, LLC
Greenbelt, Maryland, 20770, United States
AIG Digestive Disease Research, LLC
Florham Park, New Jersey, 07932, United States
Pinnacle Clinical Research-Austin
Austin, Texas, 78757, United States
South Texas Research Institute
Brownsville, Texas, 78520, United States
South Texas Research Institute
Edinburg, Texas, 78539, United States
LinQ Research, LLC
Pearland, Texas, 77584, United States
Pinnacle Clinical Research-San Antonio
San Antonio, Texas, 78229, United States
Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, 23602, United States
GI Select Health Research, LLC
Richmond, Virginia, 23236, United States
Velocity Clinical Spokane
Spokane, Washington, 99202, United States
Hopital du Haut Leveque
Pessac, 33604, France
Centro de Investigacion y Gastroenterologia SC
Mexico City, 06700, Mexico
Primary Completion
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 3, 2024
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: