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Non-Alcoholic Fatty Liver DiseasePhase 3NCT04142749

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

A Phase 3 study testing Oltipraz in people with Non-Alcoholic Fatty Liver Disease, run by PharmaKing at 21 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Non-Alcoholic Fatty Liver Disease
What is being tested?
Oltipraz
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
21 sitesSouth Korea
Study dates
15 Nov 2019to 26 Sep 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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.
  • A person who voluntarily agrees to participate in this clinical trial

Who cannot join

  • 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.)
Show all 28Show fewer
  • 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
  • The person who has the following medication history
  • Persons administered vitamin E (≥ 800 IU/day) or thiazolidatedione drugs or glucagon-like peptide-1 (GLP-1) agonist drugs within 12 weeks prior to screening
  • Persons who were given antiobestic drug within 12 weeks of screening For example; antiobestic drug with Central nervous system action: Amfepramone, bupropion and naltrexone, cathine, clobenzorex, dexfenfluramine, ephedrine combinations, etilamfetamine, fenfluramine, lorcaserin, mazindol, mefenorex, phentermine, sibutramine, Peripheral neurotic Obesity drugs: Orlistat, Rimonabant, etc
  • A person who received medications that could cause fatty liver disease within 8 weeks prior to screening For example; Administration of systemic glucocorticoids for more than two weeks Anabolic steroid-based drug, Estrogen-based drug, Azole-based antimicrobial agent, Nucleoside, Nucleotide reverse transcriptase inhibitor-based drug, Tetracycline-based drug, Amiodarone, tamoxifen, methotrexate, valproic acid, etc
  • A person who administered drugs that may affect the progress of non-alcoholic fatty liver disease within 4 weeks prior to screening or who require administration during clinical trials For example; Silymarin, biphenyl dimethyl dicarboxylate (DDB), ursodeoxycholic acid (UDCA), S-adenosyl-L-methionine (SAMe), betaine, pentoxyfylline, sodium-glucose cotransporter-2 (SGLT-2) inhibitor, omega 3 fatty acid, etc.
  • However, the following drugs can be registered if they are under stable dosage for at least 12 weeks and are expected to remain unchanged during clinical trials; Sulfonylurea-based drug, metformin, insulin, dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor), a-glucosidase inhibitor (a-GI), meglitinide-based drug, statin-based drug, fibrate-based drug, nicotinic acid, ezetimibe, beta-blockers based drug, thiazide based drug
  • A person who receive non-drug treatment that may affect the liver within 4 weeks prior to screening.
  • A person who administered/treated with other clinical trials/medical devices within 4 weeks prior to screening
  • Those who are not able to MRS(I)
  • A female who is pregnant, may be pregnant, or is lactating
  • A person who is not willing to use appropriate contraceptives during this clinical trial.
  • A person who is hypersensitive to the Investigational Product
  • A person who is deemed ineligible for clinical trials by the investigator

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

South Korea21 sites

  • Catholic University Bucheon ST. Mary's Hospital

    Bucheon-si

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si

  • Dong-A University Hospital

    Busan, 49201

  • Keimyung University Dongsan Medical Center

    Daegu

  • Gangneung Asan Medical Center

    Gangneung-si

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggi-do, 411-706

  • NHUS Ilsan Hospital

    Goyang-si, 410-719

  • Inha University Hospital

    Incheon, Junggu

  • Seoul National University Hospital

    Seoul, 110-744

  • Boramae Hospital

    Seoul, 156-707

  • Chung-Ang University Hosptial

    Seoul

  • Hallym University Gangnam Sungsim Hospital

    Seoul

  • Hanyang University Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • National Medical Center

    Seoul

  • Severance Hospital

    Seoul

  • Soonchunhyang University Seoul Hospital

    Seoul

  • Yonsei University Gangnam Severance Hospital

    Seoul

  • Ajou University School of Medicine

    Suwon

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

    Uijeongbu-si, Gyeonggi-do

  • Wonju Severance Christian Hospital

    Wanju

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Oltipraz

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

Read the detailed description

Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK) activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1 (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c. Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.

Being tested
Oltipraz, Placebos
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OltiprazDrug

    Total 90mg, By mouth, TID

  • PlacebosDrug

    Also called Placebo

    Total 90mg, By mouth, TID

Study groups in NCT04142749
Study groupRoleWhat they receive
OltiprazActive comparatorOltipraz 30mg
Receives: Drug: Oltipraz
PlaceboPlacebo comparatorPlacebo 30mg
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Variation of liver fat assessed

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

    Measured: 24 weeks compared to the baseline

Secondary outcomes (10)

  1. The variation in the amount of liver fat

    The variation in the amount of liver fat assessed by the MRS at the time of 24 weeks compared to the baseline

    Measured: 24 weeks compared to the baseline

  2. Variation of liver fat certificate grade

    Variation of liver fat certificate grade assessed by ultrasonic waves

    Measured: 24 weeks compared to the baseline

  3. Variation of NFS variation

    Variation of NFS at 24 weeks compared to the baseline

    Measured: 24 weeks compared to the baseline

  4. Variation of liver elasticities and fatty acids

    Variation of liver elasticities and fatty acids assessed by fibroscan at 24 weeks time compared to baseline

    Measured: 24 weeks compared to the baseline

  5. FIB-4

    Variation of FIB-4 from 8 weeks, 16 weeks and 24 weeks to baseline

    Measured: 8 weeks, 16 weeks and 24 weeks

  6. BMI

    BMI variation at 8 weeks, 16 weeks and 24 weeks relative to the baseline

    Measured: 8 weeks, 16 weeks and 24 weeks

  7. Variation of ALT, AST, γ-glutamyl transferase (GGT)

    Variation of ALT, AST, γ-glutamyl transferase (GGT) in time of 8 weeks, 16 weeks and 24 weeks relative to the baseline

    Measured: 8 weeks, 16 weeks and 24 weeks

  8. Cholesterol (total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very low-density lipoprotein (VLDL), triglyceride (TG)

    Variation of Cholesterol (total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very low-density lipoprotein (VLDL), triglyceride (TG)

    Measured: 8 weeks, 16 weeks and 24 weeks

  9. Variation of Homeostatic model adjustment-insulin resistance (HOMA-IR) index

    Variation of Homeostatic model adjustment-insulin resistance (HOMA-IR = fasting insulin (μU/mL) × fasting glucose (mmol/L) / 22.5)

    Measured: 24 weeks compared to the baseline

  10. Waist circumference

    The variation of waist circumference compared to the baseline at 24 weeks

    Measured: 24 weeks compared to the baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start15 Nov 2019
  3. Primary completion2 Sep 2022
  4. Study completion26 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04142749
Sponsor's protocol ID
PMK-N01GI1-P3
Status last verified
Oct 2022
First submitted
19 Sep 2019
Last updated
6 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oltipraz in people with Non-Alcoholic Fatty Liver Disease, run by PharmaKing at 21 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation of liver fat assessed (time frame: 24 weeks compared to the baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04142749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.

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