Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients

NCT02491905 | Completed Phase 2 DMC

• 1 other identifier: 12-HS-HP-09-1
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low dose, high dose, and placebo control group.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline

  12 weeks

Secondary Outcomes (7)

• Changes in Alanine Transaminase (ALT)

  8 and 12 week

• Changes in Asparate Transaminase (AST)

  8 and 12 week

• Changes in cholesterol

  8 and 12 week

• Changes in triglyceride

  8 and 12 week

• Changes in free fatty acid

  8 and 12 week

Study Arms (3)

low dose HL tablet

EXPERIMENTAL

HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal

Drug: HL tablet

high dose HL tablet

EXPERIMENTAL

HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal

Drug: HL tablet

placebo group

PLACEBO COMPARATOR

Placebo by oral administration, twice daily in an hour after meal

Drug: Placebo

Interventions

HL tablet DRUG

high dose HL tablet; low dose HL tablet

Placebo DRUG

placebo group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 19 and 75
• Non-alcoholic fatty liver disease patient
• Diagnosed by abdomen ultrasonic examination
• Non-drinker (alcohol intake per week : female-under 140g, male-under 210g)
• ALT or AST higher than normal range (not over 4 times normal range)
• Voluntary agreement and enrollment

You may not qualify if:

• The ratio of AST/ALT over 2
• Type I diabetes mellitus patient
• Any dysfunction of liver besides non-alcoholic fatty liver disease
• Alcoholic fatty liver disease patient or heavy drinker
• Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months
• Patient taking any product which affects the BMI or hyperlipidemia
• Any dyscrasia that investigator considers not to appropriate for this study
• Bariatric surgery within 6 months
• Any disease which is able to change the distribution of cytokines
• Any treatment that affects liver functions within 1 month
• Participation in other clinical trials within 3 months
• Person who can not use MRS
• Pregnancy or breast-feeding
• Fertile women who do not use contraception
• Sensitive to the investigational product

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Huons

Ansan, Kyeonggi-do, 426791, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 8, 2015
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

KR (1)