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
Sponsor study identifier
interventional
60
1 country
20
Study Start
March 15, 2022
Actual (reported)Primary Completion
April 15, 2023
Actual (reported)Study Completion
July 7, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 7, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 15, 2022
Actual (reported)July 13, 2022
Actual (reported)July 15, 2022
Actual (reported)April 15, 2023
Actual (reported)July 7, 2023
Actual (reported)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
1 rencofilstat 75 mg softgel capsule, 75 mg daily dose, QD 120 days
2 rencofilstat 75 mg softgel capsules, 150 mg daily dose, QD 120 days
3 rencofilstat 75 mg softgel capsules, 225 mg daily dose, QD 120 days
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
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.
60 participants (actual enrollment reported by the registry).
First Submitted
July 13, 2022
First Posted
July 15, 2022
Study Start
March 15, 2022
Actual (reported)Primary Completion
Fibrosis Reduction in Non Alcoholic Steatohepatitis
3 softgel capsules
Contact the study team to confirm eligibility.
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
April 15, 2023
Actual (reported)Study Completion
July 7, 2023
Actual (reported)Last Updated
June 13, 2024
Record last verified: 2024-06
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Source: ClinicalTrials.gov.
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