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

Status: Active_not_recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female between 18 and 75 years of age (inclusive).

• Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.

• 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).

• 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).

• 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.

Locations
United States
Alabama
Medical Affiliated Research Center
Huntsville
Arkansas
Preferred Research Partners, Inc.
Little Rock
Arkansas Gastroenterology
North Little Rock
Arizona
Arizona Liver Health-Chandler
Chandler
Arizona Liver Health
Peoria
Adobe Clinical Research, LLC
Tucson
Arizona Liver Health-Tuscon
Tucson
California
National Research Institute
Huntington Park
National Research Institute
Los Angeles
National Research Institute
Panorama City
National Research Institute
Santa Ana
Florida
Synergy Healthcare, LLC
Bradenton
Tampa Bay Medical Research, Inc.
Clearwater
Top Medical Research, Inc.
Cutler Bay
Integrity Clinical Research, LLC
Doral
Evolution Clinical Trials, Inc.
Hialeah Gardens
Borland Groover Clinical Research
Jacksonville
Ocala GI Research
Lady Lake
Accel Research Sites-Lakeland CRU
Lakeland
Entrust Clinical Research
Miami
Future Care Solutions, LLC
Miami
United Reseach Group
Miami
Omega Research Consultants, LLC
Orlando
Progressive Medical Research
Port Orange
Covenant Research and Clinics
Sarasota
Georgia
Southeast Clinical Research Center
Dalton
Gastrointestinal Specialists of Georgia, PC
Marietta
Indiana
Digestive Research Alliance of Michiana, LLC
South Bend
Louisiana
Delta Research Partners
Bastrop
Maryland
Mid-Atlantic GI Research, LLC
Greenbelt
New Jersey
AIG Digestive Disease Research, LLC
Florham Park
Texas
Pinnacle Clinical Research-Austin
Austin
South Texas Research Institute
Brownsville
South Texas Research Institute
Edinburg
LinQ Research, LLC
Pearland
Pinnacle Clinical Research-San Antonio
San Antonio
Virginia
Bon Secours Liver Institute of Hampton Roads
Newport News
GI Select Health Research, LLC
Richmond
Washington
Velocity Clinical Spokane
Spokane
Other Locations
France
Hopital du Haut Leveque
Pessac
Mexico
Centro de Investigacion y Gastroenterologia SC
Mexico City
Time Frame
Start Date: 2022-10-15
Completion Date: 2025-09
Participants
Target number of participants: 120
Treatments
Experimental: Cohort A: Rencofilstat 75 mg
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 75 mg daily.
Experimental: Cohort B: Rencofilstat 150 mg
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 150 mg daily.
Experimental: Cohort C: Rencofilstat 225 mg
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 225 mg daily.
Placebo_comparator: Cohort D: Placebo
Eighty-four (84) biopsy-proven NASH F2 / F3 subjects to complete study on matching placebo.
Sponsors
Leads: Hepion Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov