A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3
ALTITUDE
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
1 other identifier
interventional
60
1 country
20
Brief 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. Antifibrotic biomarker activity will be evaluated on an exploratory basis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2022
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2022
CompletedFirst Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2023
CompletedJune 13, 2024
June 1, 2024
1.1 years
July 13, 2022
June 11, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
120 Days
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
120 Days
Study Arms (3)
Cohort A: rencofilstat 75 mg
EXPERIMENTAL1 rencofilstat 75 mg softgel capsule, 75 mg daily dose, QD 120 days
Cohort B: rencofilstat 150 mg
EXPERIMENTAL2 rencofilstat 75 mg softgel capsules, 150 mg daily dose, QD 120 days
Cohort C: rencofilstat 225 mg
EXPERIMENTAL3 rencofilstat 75 mg softgel capsules, 225 mg daily dose, QD 120 days
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- i. 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Arizona Liver Health-Chandler
Chandler, Arizona, 85224, United States
Arizona Liver Health-Glendale
Peoria, Arizona, 85381, United States
Adobe Clinical Research, LLC
Tucson, Arizona, 85712, United States
Arizona Liver Health-Tucson
Tucson, Arizona, 85712, United States
Velocity Clinical Research-Chula Vista
Chula Vista, California, 91911, United States
Velocity Clinical Research-San Diego
La Mesa, California, 91942, United States
Synergy Healthcare, LLC
Bradenton, Florida, 34208, United States
Covenant Metabolic Specialists-Fort Myers
Fort Myers, Florida, 33912, United States
Evolution Clinical Trials, Inc.
Hialeah Gardens, Florida, 33016, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Covenant Metabolic Specialists-Sarasota
Sarasota, Florida, 34240, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047, United States
Coastal Reseach Institute
Fayetteville, North Carolina, 28304, United States
Optimed Research
Columbus, Ohio, 43235, United States
Clinical Research Institute of Ohio
Westlake, Ohio, 44145, United States
Pinnacle Clinical Research-Austin
Austin, Texas, 78757, United States
Apex Mobile Clinical Research
Bellaire, Texas, 77401, United States
South Texas Research Institute
Edinburg, Texas, 78539, United States
Pinnacle Clinical Research-Georgetown
Georgetown, Texas, 78626, United States
Pinnacle Clinical Research-San Antonio
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 39982177DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 15, 2022
Study Start
March 15, 2022
Primary Completion
April 15, 2023
Study Completion
July 7, 2023
Last Updated
June 13, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share