NCT05084404

Efficacy and Safety of Guanabenz for Nonalcoholic Fatty Liver Disease

Phase II Physician-initiated Clinical Trial Investigating the Efficacy and Safety of Guanabenz Acetate for Non-alcoholic Fatty Liver Disease Associated With Hypertension

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Yokohama City University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of 4 mg/day of WY-8678 (guanabenz acetate) and 8 mg/day of WY-8678 (guanabenz acetate) in patients with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH patients) with hypertension

Conditions

• Nonalcoholic Fatty Liver
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Experimental: 4 mg/day of WY-8678 (guanabenz acetate)	Patients with nonalcoholic fatty liver disease are administered 4 mg/day of WY-8678 (guanabenz acetate) twice daily for 16 weeks
DRUG	Experimental: 8 mg/day of WY-8678 (guanabenz acetate)	Patients with nonalcoholic fatty liver disease are administered 8 mg/day of WY-8678 (guanabenz acetate) twice daily for 16 weeks

Timeline

• Start date: 2021-10-29
• Primary completion: 2023-02-28
• Completion: 2023-06-30
• First posted: 2021-10-19
• Last updated: 2022-09-27

Locations

1 site across 1 country: Japan