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Completed

NCT Number: NCT02491905

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Huons

Ansan, Kyeonggi-do, 426791, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Any conditions that the investigator considers not to appropriate for this study

Treatment and study plan

HL tablet

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Changes in Alanine Transaminase (ALT)

    Time frame: 8 and 12 week

  2. Changes in Asparate Transaminase (AST)

    Time frame: 8 and 12 week

  3. Changes in cholesterol

    Time frame: 8 and 12 week

  4. Changes in triglyceride

    Time frame: 8 and 12 week

  5. Changes in free fatty acid

    Time frame: 8 and 12 week

  6. Changes in insulin resistance

    Time frame: 8 and 12 week

  7. Changes in Body Mass Index (BMI)

    Time frame: 8 and 12 week

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Official study title

Phase 2 Study to Assess Safety and Efficacy of HL Tablet on Reducing Hepatic Fat in Non-alcoholic Fatty Liver Disease Patients

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2015
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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