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Antifibrotic

Cohort A: rencofilstat 75 mg for Nonalcoholic Steatohepatitis (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

ALTITUDE Trial Summary

This trialevaluates the safety & efficacy of a drug for adults with NASH & compensated Fibrosis stage F2/3 to assess changes in biomarkers, safety labs & clinical events.

Eligible Conditions

Nonalcoholic Steatohepatitis (NASH) with Fibrosis

ALTITUDE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

ALTITUDE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hepion Pharmaceuticals, Inc.Lead Sponsor

4 Previous Clinical Trials

481 Total Patients Enrolled

Frequently Asked Questions

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

What potential risks are associated with the use of rencofilstat 150 mg in Cohort B?

"As this is a Phase 2 study and no efficacy data exists for Cohort B: rencofilstat 150 mg, we gave it an assessment of 2 in terms of safety."

Answered by AI

How many research facilities are conducting this trial?

"Evolution Clinical Trials, Inc. in Hialeah Gardens and Pinnacle Clinical Research-Georgetown in Georgetown are two of the twenty accessible clinical trial sites with Covenant Metabolic Specialists-Fort Myers in Fort Myers being another example. The remaining locations can be found on our website."

Answered by AI

Does this experiment offer opportunities for senior citizens to participate?

"The minimum age for participation in this clinical trial is 18 and the maximum age permissible is 75."

Answered by AI

Are there still openings for participants in this trial?

"According to clinicaltrials.gov, this particular research program is no longer recruiting participants, as the activity was originally posted on September 15th 2022 and last updated December 7th 2022. However, there are currently 401 other medical studies actively looking for volunteers at present."

Answered by AI

What criteria must patients meet to take part in this medical research?

"An individual's eligibility for this clinical trial is contingent upon meeting the age requirements (18-75) and demonstrating evidence of fibrosis. This medical experiment has a total capacity to accept 60 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3

2022. "A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05461105.

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