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

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.

Timeline

Start

2022-03-15

Primary completion

2023-04-15

Completion

2023-07-07

Outcome

Met primary endpoint

release “We are thrilled that the ALTITUDE-NASH trial met both its primary efficacy and safety endpoints” hepionpharma.com ↗

release “As previously announced, ALTITUDE-NASH achieved its primary and secondary endpoints, with rencofilstat demonstrating statistically significant improvements in DSI” hepionpharma.com ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rencofilstat	Small molecule	75 mg	—
Subject	rencofilstat	Small molecule	150 mg	—
Subject	rencofilstat	Small molecule	225 mg	—

Indications