A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of UN03 for Non-alcoholic Steatohepatitis (NASH) with Fibrosis

Not Applicable

• Conditions: Diseases of the digestive system

• Registration Number: KCT0005206
• Lead Sponsor: Hanyang University Seoul Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) Men and women aged 19 and over
2) Those who meet all of the following criteria
? liver fat on MRI-PDFF test
? fibrosis in the liver by MRE test
3) Those who are willing to maintain the same lifestyle habits (exercise, alcohol intake, diet, etc.) maintained for at least 4 weeks before screening
4) A person who voluntarily consents in writing to participate in this clinical trial

Exclusion Criteria

1) Those who have confirmed the following history of liver disease at the time of screening
? Acute and chronic viral hepatitis
? decompensated cirrhosis or liver cancer
2) Those who have confirmed the following medical history or surgery at the time of screening
? Severe heart disease or severe cerebrovascular disease
? malignant tumor
3) The following accompanying diseases were identified at the time of screening
? Hypertension (systolic blood pressure> 180 mmHg or diastolic blood pressure> 110 mmHg)
? Type 1 diabetes or uncontrolled type 2 diabetes

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety is evaluated after UN03 administration in patients with nonalcoholic steatohepatitis (NASH) who have confirmed liver fat content in Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) and fibrosis in magnetic resonance enterography (MRE).

Secondary Outcome Measures

Name	Time	Method
The effectiveness of non-alcoholic steatohepatitis (NASH) in patients with non-alcoholic steatohepatitis (NASH) with an MRI-PDFF phase of hepatic fat content and MRE fibrosis is explored after administration.