NCT04342793

A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Study to Explore the Safety and Efficacy of ALS-L1023 in Patients With Non-alcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: AngioLab, Inc. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis

Detailed description

Besides the main objectives, there are other objectives as follows: 1. To evaluate efficacy of ALS-L1023 for liver fibrosis and steatosis by noninvasive imaging biomarker MRI-PDFF and MRE 2. To determine optimized dose of ALS-L1023 in NASH disease

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Placebo oral tablet	Placebo
DRUG	ALS-L1023 1,200mg	ALS-L1023
DRUG	ALS-L1023 1,800mg	ALS-L1023

Timeline

• Start date: 2019-12-04
• Primary completion: 2021-05-11
• Completion: 2021-05-11
• First posted: 2020-04-13
• Last updated: 2022-08-11

Locations

1 site across 1 country: South Korea