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NASH With FibrosisPhase 2ALTITUDENCT05461105

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

A Phase 2 study testing rencofilstat, 75 mg, rencofilstat, 150mg and rencofilstat, 225 mg in people with NASH With Fibrosis, run by Hepion Pharmaceuticals, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, open-label, parallel-dosing, multi-center study to evaluate the safety and efficacy of rencofilstat as evidenced by assessing changes in the HepQuant Shunt Disease Severity Index Score (DSI), safety labs, and clinical events in adult NASH subjects with compensated Fibrosis stage F 2/3. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NASH With Fibrosis
What is being tested?
rencofilstat, 75 mg, rencofilstat, 150mg and rencofilstat, 225 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
20 sitesUnited States
Study dates
15 Mar 2022to 7 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female between 18 and 75 years of age (inclusive).
  • BMI above 25.0 kg/m2
  • Biopsy confirmed NASH with histologic liver fibrosis stage 3 as defined by the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) scoring of liver fibrosis based on available historical biopsy report if the following are met:
  • Historical biopsy was obtained no more than 6 months (180 ± 5 days) prior to the first day of Screening. ii. No new therapeutic intervention for NASH of at least 2 or more weeks was made during the preceding 3-month (90-day) period (e.g., vitamin E ≥ 400 IU/day, pioglitazone, or incretins [e.g., liraglutide, semaglutide]). Subjects may be treated with vitamin E or pioglitazone as long as such subjects are maintained on a stable dose for 3 months prior to randomization, and the dose should be held constant during the trial.
  • Subjects without historical biopsy will be eligible for inclusion if their AGILE 3+ score using the FibroScan Diagnostic App is ≥0.53. The AGILE 3+ score is composed of: FibroScan fibrosis score, laboratory values (AST, ALT, Platelets), and clinical parameters (Age, Sex, Diabetes status) to calculate the AGILE 3+ score.

Who cannot join

  • Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus antibodies (HIVAb). If HCVAb test is positive, then an HCV-RNA test will be performed. If this test is negative, the subject is allowed to participate in the study, as long as the subject meets all other inclusion criteria and has never been treated for HCV or was treated >2 years ago and achieved a sustained virologic response at that time.
  • Subjects with symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection identified during the screening period.
  • At screening, subjects with uncontrolled hypertension (either treated or untreated) defined as a systolic blood pressure >160mmHg or a diastolic blood pressure of >110mmHG.
  • Subjects on either a non-selective beta blocker or an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) who are unwilling/unable to delay taking their normal dose the morning of HepQuant testing.
  • Subjects with transaminases >5 x upper limit of normal (ULN).
  • Subjects with ALP >2 x ULN.
Show all 14Show fewer
  • Subjects with total serum bilirubin >1.5 x ULN, unless the subject has Gilbert's Syndrome, in which case the subject can be enrolled provided the direct bilirubin is within 30% of the total bilirubin.
  • Subjects with a platelet count <140,000/mm3.
  • Subjects with an INR ≥ 1.3 in the absence of anticoagulants.
  • Subjects with albumin <3.5 g/dL.
  • Model for End-Stage Liver Disease (MELD) score >12, unless due to an alternate etiology such as therapeutic anticoagulation or Gilbert's.
  • An estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] method).
  • Subjects with hemoglobin A1c (HbA1c) >9.5%.
  • Other well documented causes of chronic liver disease according to standard diagnostic procedures.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Pinnacle Clinical Research-Austin

    Austin, Texas, 78757

  • Apex Mobile Clinical Research

    Bellaire, Texas, 77401

  • Synergy Healthcare, LLC

    Bradenton, Florida, 34208

  • Arizona Liver Health-Chandler

    Chandler, Arizona, 85224

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • Velocity Clinical Research-Chula Vista

    Chula Vista, California, 91911

  • Optimed Research

    Columbus, Ohio, 43235

  • South Texas Research Institute

    Edinburg, Texas, 78539

  • Coastal Reseach Institute

    Fayetteville, North Carolina, 28304

  • Covenant Metabolic Specialists-Fort Myers

    Fort Myers, Florida, 33912

  • Pinnacle Clinical Research-Georgetown

    Georgetown, Texas, 78626

  • Evolution Clinical Trials, Inc.

    Hialeah Gardens, Florida, 33016

  • Velocity Clinical Research-San Diego

    La Mesa, California, 91942

  • Arizona Liver Health-Glendale

    Peoria, Arizona, 85381

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Pinnacle Clinical Research-San Antonio

    San Antonio, Texas, 78229

  • Covenant Metabolic Specialists-Sarasota

    Sarasota, Florida, 34240

  • Adobe Clinical Research, LLC

    Tucson, Arizona, 85712

  • Arizona Liver Health-Tucson

    Tucson, Arizona, 85712

  • Clinical Research Institute of Ohio

    Westlake, Ohio, 44145

Other trials in United States

About this study

Official title: ALTITUDE NASH: A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With Nonalcoholic Steatohepatitis Stage 3 Fibrosis

This is a randomized, open-label, parallel-dosing, multi-center study to evaluate the safety and efficacy of rencofilstat as evidenced by assessing changes in the HepQuant Shunt Disease Severity Index Score (DSI), safety labs, and clinical events in adult NASH subjects with compensated Fibrosis stage F 2/3. Antifibrotic biomarker activity will be evaluated on an exploratory basis.

Read the detailed description

This study consists of 3 phases: (i) Screening and Randomization; (ii) treatment; and (iii) follow up. During Screening, each subject will provide informed consent prior to starting any study specific procedures. The randomization of the NASH F3 subjects will be performed in a 1:1:1 ratio between rencofilstat 75 mg, rencofilstat 150 mg, and rencofilstat 225 mg. During the treatment period, randomized subjects will be provided the treatment and assessments to monitor safety, tolerability and efficacy. All subjects will receive study drug in the morning. Prior to dosing, subjects can have a light breakfast, avoiding high fat meals. In the follow up phase, investigational product (IP) will be discontinued followed by 14 days of safety follow-up.

Being tested
rencofilstat, 75 mg, rencofilstat, 150mg, rencofilstat, 225 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rencofilstat, 75 mgDrug

    1 softgel capsule

  • rencofilstat, 150mgDrug

    2 softgel capsules

  • rencofilstat, 225 mgDrug

    3 softgel capsules

Study groups in NCT05461105
Study groupRoleWhat they receive
Cohort A: rencofilstat 75 mgExperimental1 rencofilstat 75 mg softgel capsule, 75 mg daily dose, QD 120 days
Receives: Drug: rencofilstat, 75 mg
Cohort B: rencofilstat 150 mgExperimental2 rencofilstat 75 mg softgel capsules, 150 mg daily dose, QD 120 days
Receives: Drug: rencofilstat, 150mg
Cohort C: rencofilstat 225 mgExperimental3 rencofilstat 75 mg softgel capsules, 225 mg daily dose, QD 120 days
Receives: Drug: rencofilstat, 225 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Primary Efficacy Endpoint

    Measured: 120 Days

  2. 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.

    Primary Safety Endpoint

    Measured: 120 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2022
  2. Study start15 Mar 2022
  3. Primary completion15 Apr 2023
  4. Study completion7 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05461105
Sponsor's protocol ID
HEPA-CRV431-210
Acronym
ALTITUDE
Status last verified
Jun 2024
First submitted
13 Jul 2022
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Harrison SA, Mayo P, Hobbs T, Zhao C, Canizares C, Foster R, McRae MP, Helmke SM, Everson GT. Rencofilstat Treatment Improves Liver Function in MASH With Advanced Fibrosis as Quantified by HepQuant DuO. Liver Int. 2025 Mar;45(3):e70036. doi: 10.1111/liv.70036.

    PubMed 39982177

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rencofilstat, 75 mg, rencofilstat, 150mg and rencofilstat, 225 mg in people with NASH With Fibrosis, run by Hepion Pharmaceuticals, Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 120 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05461105, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.

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