Rencofilstat for NASH with Advanced Liver Fibrosis
(ASCEND Trial)

Recruiting in Palo Alto (17 mi)

+40 other locations

Overseen byStephen Harrison, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hepion Pharmaceuticals, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests Rencofilstat, a medication that may improve liver damage, in adults with NASH and significant liver fibrosis. The drug works by reducing liver scarring and damage.

Research Team

Stephen Harrison, MD

Principal Investigator

Pinnacle Clinical Research

Eligibility Criteria

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.

Inclusion Criteria

My liver has moderate to severe scarring according to a specific biopsy test.

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

I am between 18 and 75 years old.

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Exclusion Criteria

Subjects with ALP >2 x ULN

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

An estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] method)

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Treatment Details

Interventions

Rencofilstat (Antifibrotic Agent)

Trial OverviewThe 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.

Participant Groups

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.