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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005206

Enrollment

Registered

2020-07-08

Start date

2020-09-01

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Multicenter, randomized, double-blind, placebo-controlled, phase 2a clinical trial

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Korea, Republic of

Contacts

Public ContactDeawon Jun

Hanyang University

Outcome results