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Antifibrotic

Cohort A: rencofilstat 75 mg for Liver cirrhosis (ALTITUDE Trial)

Phase 2
Waitlist Available
Research Sponsored by Hepion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing rencofilstat, a medication for adult patients with moderate-stage NASH. It aims to reduce liver scarring and improve liver function.

Eligible Conditions
  • Liver cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in DSI score of subjects taking rencofilstat (75 mg, 150 mg, 225 mg), determined using HepQuant SHUNT Test, on Day 60, and Day 120.
The percent of subjects taking rencofilstat (75 mg, 150 mg, 225 mg) that have experienced treatment-emergent adverse events, serious adverse events, adverse events of special interest, physical and laboratory abnormalities.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort C: rencofilstat 225 mgExperimental Treatment1 Intervention
3 rencofilstat 75 mg softgel capsules, 225 mg daily dose, QD 120 days
Group II: Cohort B: rencofilstat 150 mgExperimental Treatment1 Intervention
2 rencofilstat 75 mg softgel capsules, 150 mg daily dose, QD 120 days
Group III: Cohort A: rencofilstat 75 mgExperimental Treatment1 Intervention
1 rencofilstat 75 mg softgel capsule, 75 mg daily dose, QD 120 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rencofilstat, 75 mg
2022
Completed Phase 2
~60
rencofilstat, 150mg
2022
Completed Phase 2
~60
rencofilstat, 225 mg
2022
Completed Phase 2
~60

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Who is running the clinical trial?

Hepion Pharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
481 Total Patients Enrolled
~17 spots leftby Nov 2025
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