Oltipraz for Liver Fat Reduction in Patients With Non-alcoholic Fatty Liver Disease Except for Liver Cirrhosis

NCT04142749 | Completed Phase 3

• 1 other identifier: PMK-N01GI1-P3
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 21

Brief Summary

Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Variation of liver fat assessed

  Variation of liver fat assessed by MRS at 24 weeks compared to the baseline (%)

  24 weeks compared to the baseline

Secondary Outcomes (10)

• The variation in the amount of liver fat

  24 weeks compared to the baseline

• Variation of liver fat certificate grade

  24 weeks compared to the baseline

• Variation of NFS variation

  24 weeks compared to the baseline

• Variation of liver elasticities and fatty acids

  24 weeks compared to the baseline

• FIB-4

  8 weeks, 16 weeks and 24 weeks

Other Outcomes (9)

• The Variation of biomarkers

  8 weeks, 16 weeks and 24 weeks

• The Variation of biomarkers

  8 weeks, 16 weeks and 24 weeks

• The Variation of biomarkers

  8 weeks, 16 weeks and 24 weeks

Study Arms (2)

Oltipraz

ACTIVE COMPARATOR

Oltipraz 30mg

Drug: Oltipraz

Placebo

PLACEBO COMPARATOR

Placebo 30mg

Drug: Placebos

Interventions

Oltipraz DRUG

Total 90mg, By mouth, TID

Oltipraz

Placebos DRUG

Total 90mg, By mouth, TID

Also known as: Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• A person the ages of 19 and 75 years old
• Patients with non-alcoholic fatty liver disease other than cirrhosis that meets all of the following criteria:
• Abdominal ultrasonography of Screening indicates that the liver is brighter than the spleen or kidneys, causing suspected fatty liver
• Persons with liver fat content is 20% or more on the MRS
• Those who do not have significant alcohol intake within two years before screening (men: no more than 210 g per week; women: no more than 140 g per week)
• Those who with an alcohol use disorder identification test (AUDIT) result point is no more than 7, during screening.
• Persons with body mass index (BMI) more than 23 kg/m2 during screening
• A person who satisfies the following laboratory test results when screening
• Platelet ≥ 130,000/㎣
• White blood cell (WBC) ≥ 3,000/㎣
• Absolute neutrophil count (ANC) ≥ 1,500/㎣
• Albumin ≥ 3.5 g/dL
• Serum creatinine ≤ 1.5 X upper limit of normal (ULN)
• ULN \< Alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 250 IU/L
• A person who is willing to maintain the same lifestyle (exercise, alcohol intake, diet, etc.) maintained for at least four weeks before screening during the clinical trial period.

You may not qualify if:

• A person who has history of following disease or surgery
• Malignant tumour with liver cancer
• Malignant tumor excluding liver cancer, However, registration is possible in the following cases
• If the investigator determines that the patient has been completely cured after maintaining the condition for at least five years
• In case of basal cell or squamous cell carcinoma of the skin, the patient is able to maintain a complete condition for more than three years in the case of cainoma in the cervix (CIN) and carcinema in situ (CIS), and other areas.
• autoimmune disease (e.g., inflammatory bowel disease, autoimmune hemolytic disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis, severe psoriasis, etc.)
• Bariatric surgery within 24 weeks before screening
• A Person who has comorbidity of the following diseases at the time of screening
• Liver cirrhosis identified by an epidemiological or histological examination
• Cumulative disease (e.g., alcohol liver disease, toxic hepatitis, autoimmune liver disease, metabolic liver disease, biliary closure, etc.) that may indicates liver abnormalities other than non-alcoholic fatty liver disease
• A Person who has been infected or has Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
• Type 1 diabetes or type 2 diabetes (hemoglobin A1c (HbA1c) \> 9%)
• A person who has positive result of Human immunodeficiency virus antibody (HIV Ab).
• A persons with conditions that may affect the effectiveness and safety by investigator
• A person with AST/ALT ratio of more than 2 at screening

Sponsors & Collaborators

• PharmaKing: lead

Study Sites (21)

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 411-706, South Korea

Location

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Location

Inha University Hospital

Incheon, Junggu, South Korea

Location

Catholic University Bucheon ST. Mary's Hospital

Bucheon-si, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Gangneung Asan Medical Center

Gangneung-si, South Korea

Location

NHUS Ilsan Hospital

Goyang-si, 410-719, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Boramae Hospital

Seoul, 156-707, South Korea

Location

Chung-Ang University Hosptial

Seoul, South Korea

Location

Hallym University Gangnam Sungsim Hospital

Seoul, South Korea

Location

Hanyang University Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

National Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Soonchunhyang University Seoul Hospital

Seoul, South Korea

Location

Yonsei University Gangnam Severance Hospital

Seoul, South Korea

Location

Ajou University School of Medicine

Suwon, South Korea

Location

Wonju Severance Christian Hospital

Wanju, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

oltipraz

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Yun-Jun Kim, MD.PhD

  Seoul Nat'l Uni. Hospital

  PRINCIPAL INVESTIGATOR

• Changuk Kim, MD.PhD

  The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Gapjin Chun, MD.PhD

  Gangneung Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Taehui Lee, MD.PhD

  Kunyang University Hospital

  PRINCIPAL INVESTIGATOR

• Byeongguk Jang, MD.PhD

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

• Yanghyeon Baek, MD.PhD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

• Byeonggwan Kim, MD.PhD

  Boramae Hospital

  PRINCIPAL INVESTIGATOR

• Yeongseok Kim, MD.PhD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

• Jaeyeong Chang, MD.PhD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

• Jaeyeong Jung, MD.PhD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

• Hyeonung Lee, MD.PhD

  Yonsei University Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

• Doyeong Kim, MD.PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Munyeong Kim, MD.PhD

  Wonju Severance Christian Hospital

  PRINCIPAL INVESTIGATOR

• Junseong Lee, MD.PhD

  Inje University Ilsan Baek Hospital

  PRINCIPAL INVESTIGATOR

• Jinu Lee, MD.PhD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

• Hyeongjun Kim, MD.PhD

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

• Sanghun Park, MD.PhD

  Hallym University Gangnam Sungsim Hospital

  PRINCIPAL INVESTIGATOR

• Daewon Jun, MD.PhD

  Hanyang University

  PRINCIPAL INVESTIGATOR

• Chun Kyun Lee, MD.PhD

  National Health Insurance Service Ilsan Hospital

  PRINCIPAL INVESTIGATOR

• Jaeyun Jung, MD.PhD

  National medical center

  PRINCIPAL INVESTIGATOR

• Jihun Kim, MD.PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Huieon Kim, MD.PhD

  Catholic University Bucheon ST. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: October 29, 2019
• Study Start: November 15, 2019
• Primary Completion: September 2, 2022
• Study Completion: September 26, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

KR (21)