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Nonalcoholic SteatohepatitisPhase 3NCT05731596

Comparative Clinical Study to Evaluate the Efficacy and Safety of Rosuvastatin Vs CoQ10 on Nonalcoholic Steatohepatitis

A Phase 3 study testing Rosuvastatin 20 Mg Oral Tablet and Coenzyme Q10 100 MG Oral Capsule in people with Nonalcoholic Steatohepatitis, run by Tanta University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will be a randomized, controlled, parallel study that aims to evaluate the efficacy and safety of Rosuvastatin versus Coenzyme Q10 on nonalcoholic steatohepatitis patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nonalcoholic Steatohepatitis
What is being tested?
Rosuvastatin 20 Mg Oral Tablet and Coenzyme Q10 100 MG Oral Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
Jun 2023to Apr 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: ≥ 18 years.
  • Gender: Both male and female patients will be included.
  • Patients have established diagnosis of NASH (based on liver ultrasonography).

Who cannot join

  • Young ages <18 years
  • Secondary causes of hepatic fat accumulation such as Significant alcohol consumption as defined by an average daily consumption of alcohol greater than 30 g/day in men and greater than 20 g/day in women or Long-term use of a steatogenic medication (e.g., non-Steroidal anti-inflammatory drugs (NSAIDs) amiodarone, methotrexate, tamoxifen, corticosteroids)
  • Patients with a known history of viral hepatitis, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction.
  • Patients with inflammatory diseases.
  • Subjects using any other lipid-lowering agents, or any supplements known to have antioxidant activity and omega-3 supplementation for at least 3 months before participation in the trial
  • Current Pregnancy
Show all 13Show fewer
  • Breastfeeding
  • Females On Oral Contraceptive pills
  • Patients with renal impairment
  • Patients with heart failure
  • Patients with cancer or with a history of cancer treatment
  • Any contraindications to coenzyme Q 10 Or statins like hypersensitivity to anyone
  • Patients with predisposing risk factors for myopathy/rhabdomyolysis.

Trial locations and contacts

No sites are listed yet.

Hadeer Ahmed Alsayed, B.Sc. Degree contact

00201011611651

hader.ahmed41996@gmail.com

About this study

Official title: Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Rosuvastatin Versus Coenzyme Q10 on Nonalcoholic Steatohepatitis

This study will be a randomized, controlled, parallel study that aims to evaluate the efficacy and safety of Rosuvastatin versus Coenzyme Q10 on nonalcoholic steatohepatitis patients.

Read the detailed description
  • This study will be a randomized, controlled, parallel study.
  • It will be conducted on 46 patients diagnosed with NASH
  • The patients will be randomized into two groups:

Group 1(n=23): patients will receive Rosuvastatin 20mg/day orally

Group 2(n=23): patients will receive Coenzyme Q10 100 mg/day orally

The patients will be selected from community awareness campaigns about NASH in Alexandria , Egypt . Written informed consent will be obtained from all patients. This study will be approved by the Research Ethics Committee of Tanta University and Alexandria university.

The study duration will be 3 months.

Being tested
Rosuvastatin 20 Mg Oral Tablet, Coenzyme Q10 100 MG Oral Capsule
Keywords
nonalcoholic steatohepatitis, NASH, NAFLD, Non-Alcoholic Fatty Liver Disease, Rosuvastatin, Coenzyme Q10, Fatty Liver, statin, Liver Diseases
Medical subject headings
Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Diseases

What participants receive

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

  • Rosuvastatin 20 Mg Oral TabletDrug

    Rosuvastatin 20 mg will be administered orally once daily for 3 Months

  • Coenzyme Q10 100 MG Oral CapsuleDrug

    Coenzyme Q10 100 mg will be administered orally once daily for 3 Months

Study groups in NCT05731596
Study groupRoleWhat they receive
Group 1 (Rosuvastatin group)Active comparatorPatients will receive Rosuvastatin 20mg/day orally for 3 months
Receives: Drug: Rosuvastatin 20 Mg Oral Tablet
Group 2 (CoQ10 group)ExperimentalPatients will receive Coenzyme Q10 100 mg/day orally for 3 months
Receives: Drug: Coenzyme Q10 100 MG Oral Capsule

What is being measured

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

  1. Change in liver stiffness measurement (LSM)

    LSM will be assessed by Fibro scan

    Measured: At baseline and 12th week

  2. Change in ultrasound score

    Ultrasound score will be assessed by Ultrasonography

    Measured: At baseline and 12th week

Secondary outcomes (11)

  1. Demonstrate changes in Alanine aminotransferase (ALT)

    Alanine aminotransferase (ALT) in U/L

    Measured: At baseline and 12th week

  2. Demonstrate changes in Aspartate aminotransferase (AST)

    Aspartate aminotransferase (AST) in U/L

    Measured: At baseline and 12th week

  3. Demonstrate changes in Alkaline phosphatase (ALP)

    Alkaline phosphatase (ALP) in U/L

    Measured: At baseline and 12th week

  4. Demonstrate changes in ɤ-glutamyltranspeptidase (GGT)

    ɤ-glutamyltranspeptidase (GGT) in U/L

    Measured: At baseline and 12th week

  5. Demonstrate changes in Direct bilirubin

    Direct bilirubin in mg/dl

    Measured: At baseline and 12th week

  6. Demonstrate changes in the Lipid values

    Total cholesterol(TC) in mg/dl , Triglycerides(TG) in mg/dl , LDL-Cholesterol in mg/dl , HDL-Cholesterol in mg/dl

    Measured: At baseline and 12th week

  7. Demonstrate changes in the body weight and body mass index (BMI)

    BMI in kg/m^2 will be calculated using the formula: BMI= [Weight (kg)/Height (m2)].

    Measured: At baseline and 12th week

  8. Demonstrate changes in the Inflammatory marker : CRP

    C-reactive protein in mg/L

    Measured: At baseline and 12th week

  9. Demonstrate changes in Serum cytokeratin 18 (Ck-18)

    Serum cytokeratin 18 (Ck-18) will be determined by Enzyme-linked Immunosorbent assay kits.

    Measured: At baseline and 12th week

  10. Demonstrate changes in Serum transforming growth factor-beta1 (TGF-β1)

    Serum transforming growth factor-beta1 (TGF-β1) will be determined by Enzyme-linked Immunosorbent assay kits.

    Measured: At baseline and 12th week

  11. Serum Retinol binding protein 4 (RBP-4)

    Serum Retinol binding protein 4 (RBP-4) will be determined by Enzyme-linked Immunosorbent assay kits.

    Measured: At baseline and 12th week

Timeline

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

  1. First posted16 Feb 2023
  2. Study startJun 2023 (estimated)
  3. Primary completionFeb 2024 (estimated)
  4. Study completionApr 2024 (estimated)

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
Model description
* This study will be a randomized, controlled, parallel study. * It will be conducted on 46 patients diagnosed with NASH * The patients will be randomized into two groups: 1. Group 1(n=23): patients will receive Rosuvastatin 20mg/day orally 2. Group 2(n=23): patients will receive Coenzyme Q10 100 mg/day orally
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05731596
Sponsor's protocol ID
Rosuvastatin vs Co Q10 on NASH
Status last verified
May 2023
First submitted
16 Jan 2023
Last updated
16 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.

    PubMed 26707365

  • Estes C, Anstee QM, Arias-Loste MT, Bantel H, Bellentani S, Caballeria J, Colombo M, Craxi A, Crespo J, Day CP, Eguchi Y, Geier A, Kondili LA, Kroy DC, Lazarus JV, Loomba R, Manns MP, Marchesini G, Nakajima A, Negro F, Petta S, Ratziu V, Romero-Gomez M, Sanyal A, Schattenberg JM, Tacke F, Tanaka J, Trautwein C, Wei L, Zeuzem S, Razavi H. Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030. J Hepatol. 2018 Oct;69(4):896-904. doi: 10.1016/j.jhep.2018.05.036. Epub 2018 Jun 8.

    PubMed 29886156

  • Mantovani A, Scorletti E, Mosca A, Alisi A, Byrne CD, Targher G. Complications, morbidity and mortality of nonalcoholic fatty liver disease. Metabolism. 2020 Oct;111S:154170. doi: 10.1016/j.metabol.2020.154170. Epub 2020 Jan 30.

    PubMed 32006558

  • Ekstedt M, Hagstrom H, Nasr P, Fredrikson M, Stal P, Kechagias S, Hultcrantz R. Fibrosis stage is the strongest predictor for disease-specific mortality in NAFLD after up to 33 years of follow-up. Hepatology. 2015 May;61(5):1547-54. doi: 10.1002/hep.27368. Epub 2015 Mar 23.

    PubMed 25125077

  • Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.

    PubMed 28714183

  • Vanni E, Marengo A, Mezzabotta L, Bugianesi E. Systemic Complications of Nonalcoholic Fatty Liver Disease: When the Liver Is Not an Innocent Bystander. Semin Liver Dis. 2015 Aug;35(3):236-49. doi: 10.1055/s-0035-1562944. Epub 2015 Sep 17.

    PubMed 26378641

  • Spahillari A, Mukamal KJ, DeFilippi C, Kizer JR, Gottdiener JS, Djousse L, Lyles MF, Bartz TM, Murthy VL, Shah RV. The association of lean and fat mass with all-cause mortality in older adults: The Cardiovascular Health Study. Nutr Metab Cardiovasc Dis. 2016 Nov;26(11):1039-1047. doi: 10.1016/j.numecd.2016.06.011. Epub 2016 Jun 28.

    PubMed 27484755

  • Tzanaki I, Agouridis AP, Kostapanos MS. Is there a role of lipid-lowering therapies in the management of fatty liver disease? World J Hepatol. 2022 Jan 27;14(1):119-139. doi: 10.4254/wjh.v14.i1.119.

    PubMed 35126843

  • Wang W, Zhao C, Zhou J, Zhen Z, Wang Y, Shen C. Simvastatin ameliorates liver fibrosis via mediating nitric oxide synthase in rats with non-alcoholic steatohepatitis-related liver fibrosis. PLoS One. 2013 Oct 2;8(10):e76538. doi: 10.1371/journal.pone.0076538. eCollection 2013.

    PubMed 24098525

  • Pramfalk C, Parini P, Gustafsson U, Sahlin S, Eriksson M. Effects of high-dose statin on the human hepatic expression of genes involved in carbohydrate and triglyceride metabolism. J Intern Med. 2011 Mar;269(3):333-9. doi: 10.1111/j.1365-2796.2010.02305.x. Epub 2010 Nov 18.

    PubMed 21083855

  • Farsi F, Mohammadshahi M, Alavinejad P, Rezazadeh A, Zarei M, Engali KA. Functions of Coenzyme Q10 Supplementation on Liver Enzymes, Markers of Systemic Inflammation, and Adipokines in Patients Affected by Nonalcoholic Fatty Liver Disease: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Am Coll Nutr. 2016 May-Jun;35(4):346-53. doi: 10.1080/07315724.2015.1021057. Epub 2015 Jul 9.

    PubMed 26156412

  • Chen K , Chen X , Xue H , Zhang P , Fang W , Chen X , Ling W . Coenzyme Q10 attenuates high-fat diet-induced non-alcoholic fatty liver disease through activation of the AMPK pathway. Food Funct. 2019 Feb 20;10(2):814-823. doi: 10.1039/c8fo01236a.

    PubMed 30675881

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosuvastatin 20 Mg Oral Tablet and Coenzyme Q10 100 MG Oral Capsule in people with Nonalcoholic Steatohepatitis, run by Tanta University.

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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Results are not available in the source record.

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

Contact Hadeer Ahmed Alsayed, B.Sc. Degree (00201011611651, hader.ahmed41996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in liver stiffness measurement (LSM) (time frame: At baseline and 12th week). The study lists 2 primary outcomes in all. 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 NCT05731596, which also lists 12 linked publications.

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 16 May 2023.

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