NCT05461105

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hepion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• NASH With Fibrosis

Interventions

Type	Name	Description
DRUG	rencofilstat, 75 mg	1 softgel capsule
DRUG	rencofilstat, 150mg	2 softgel capsules
DRUG	rencofilstat, 225 mg	3 softgel capsules

Timeline

• Start date: 2022-03-15
• Primary completion: 2023-04-15
• Completion: 2023-07-07
• First posted: 2022-07-15
• Last updated: 2024-06-13

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study