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Antifibrotic Agent

Rencofilstat for NASH with Advanced Liver Fibrosis (ASCEND Trial)

Phase 2
Recruiting
Led By Stephen Harrison, MD
Research Sponsored by Hepion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female between 18 and 75 years of age (inclusive)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dosing period of 1 year with 1 month observation and follow up period
Awards & highlights

ASCEND Trial Summary

This trialtests a drug to reduce fibrosis in adults with NASH, with safety and efficacy evaluated through histopathology and biomarkers.

Who is the study for?
Adults aged 18-75 with NASH and stage 2 or 3 liver fibrosis, who have a biopsy confirming the condition within the last 6 months. Participants should not have severe heart issues, decompensated cirrhosis, recent drug trials participation, uncontrolled diabetes (HbA1c >9.5%), or infections like hepatitis B/C or HIV.Check my eligibility
What is being tested?
The trial is testing Rencofilstat against a placebo to see if it can improve liver fibrosis in NASH patients. It's randomized and double-blind, meaning neither doctors nor participants know who gets the real medicine versus placebo.See study design
What are the potential side effects?
While specific side effects of Rencofilstat are not listed here, similar medications may cause digestive issues, fatigue, allergic reactions, and changes in blood tests that monitor liver function.

ASCEND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My liver biopsy shows I have NASH with specific inflammation and cell damage.
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My liver has moderate to severe scarring according to a specific biopsy test.

ASCEND Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dosing period of 1 year with 1 month observation and follow up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and dosing period of 1 year with 1 month observation and follow up period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) OR NASH resolution without worsening of fibrosis.
Secondary outcome measures
Change from baseline in ALT.
Change from baseline in AST.
Change from baseline in Pro-C3, type III collagen neo-epitopes.
+3 more

ASCEND Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort C: Rencofilstat 225 mgExperimental Treatment1 Intervention
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 225 mg daily.
Group II: Cohort B: Rencofilstat 150 mgExperimental Treatment1 Intervention
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 150 mg daily.
Group III: Cohort A: Rencofilstat 75 mgExperimental Treatment1 Intervention
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 75 mg daily.
Group IV: Cohort D: PlaceboPlacebo Group1 Intervention
Eighty-four (84) biopsy-proven NASH F2 / F3 subjects to complete study on matching placebo.

Find a Location

Who is running the clinical trial?

Hepion Pharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
205 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
47 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Stephen Harrison, MDPrincipal InvestigatorPinnacle Clinical Research
8 Previous Clinical Trials
1,611 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
937 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Rencofilstat (Antifibrotic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05402371 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Cohort B: Rencofilstat 150 mg, Cohort C: Rencofilstat 225 mg, Cohort D: Placebo, Cohort A: Rencofilstat 75 mg
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Rencofilstat Highlights & Side Effects. Trial Name: NCT05402371 — Phase 2
Rencofilstat (Antifibrotic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05402371 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05402371 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for participating in this investigation?

"This clinical trial requires participants aged 18-75. Separately, there are 102 trials for minors and 602 studies specifically aimed at seniors."

Answered by AI

Is Cohort C: Rencofilstat 225 mg an efficacious and secure medication for humans?

"The safety of Cohort C: Rencofilstat 225 mg has been assigned a score of 2. This is due to the Phase 2 status, which implies that there are some reports corroborating its safety but no data proving it's efficacy."

Answered by AI

Am I eligible to partake in this trial?

"Qualified participants for this medical trial must have a diagnosis of fibrosis and liver disease, aged between 18 and 75. The study is aiming to recruit 336 individuals in total."

Answered by AI

What is the number of participants this trial can accommodate?

"To conduct a successful trial, 336 volunteers that satisfy the predetermined criteria must be recruited. Arizona Liver Health-Chandler in Chandler and Arizona Liver Health-Tuscon in Panorama City are both participating locations."

Answered by AI

What is the prevalence of hospitals conducting this investigation?

"Currently, the trial is enrolling patients at 39 sites across America. Arizona Liver Health-Chandler in Chandler and National Research Institute located in Richmond are two of these centres, along with 37 other facilities."

Answered by AI

Is there still an opportunity to partake in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is currently recruiting patients, having been initially posted on October 15th 2022 and most recently updated December 7th 2022. 336 candidates need to be sourced from 39 different medical facilities."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
National Research Institute
Tampa Bay Medical Research, Inc.
Bon Secours Liver Institute of Hampton Roads
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recently diagnosed with fatty liver with a METAVIR score of F2-F3. Searching the internet for ways to decrease that score and found your clinical trial.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis
2022. "A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05402371.
All > Liver Fibrosis > Nash
~134 spots leftby May 2025
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