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

NCT05731596 | Unknown Phase 3

• 1 other identifier: Rosuvastatin vs Co Q10 on NASH
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Nonalcoholic Steatohepatitis

Keywords

nonalcoholic steatohepatitis; NASH; NAFLD; Non-Alcoholic Fatty Liver Disease; Rosuvastatin; Coenzyme Q10; Fatty Liver; statin; Liver Diseases

Outcome Measures

Primary Outcomes (2)

• Change in liver stiffness measurement (LSM)

  LSM will be assessed by Fibro scan

  At baseline and 12th week

• Change in ultrasound score

  Ultrasound score will be assessed by Ultrasonography

  At baseline and 12th week

Secondary Outcomes (11)

• Demonstrate changes in Alanine aminotransferase (ALT)

  At baseline and 12th week

• Demonstrate changes in Aspartate aminotransferase (AST)

  At baseline and 12th week

• Demonstrate changes in Alkaline phosphatase (ALP)

  At baseline and 12th week

• Demonstrate changes in ɤ-glutamyltranspeptidase (GGT)

  At baseline and 12th week

• Demonstrate changes in Direct bilirubin

  At baseline and 12th week

Study Arms (2)

Group 1 (Rosuvastatin group)

ACTIVE COMPARATOR

Patients will receive Rosuvastatin 20mg/day orally for 3 months

Drug: Rosuvastatin 20 Mg Oral Tablet

Group 2 (CoQ10 group)

EXPERIMENTAL

Patients will receive Coenzyme Q10 100 mg/day orally for 3 months

Drug: Coenzyme Q10 100 MG Oral Capsule

Interventions

Rosuvastatin 20 Mg Oral Tablet DRUG

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

Group 1 (Rosuvastatin group)

Coenzyme Q10 100 MG Oral Capsule DRUG

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

Group 2 (CoQ10 group)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Tanta University: lead

Related Publications (12)

• 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.

  PMID: 26707365 BACKGROUND

• 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.

  PMID: 29886156 BACKGROUND

• 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.

  PMID: 32006558 BACKGROUND

• 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.

  PMID: 25125077 BACKGROUND

• 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.

  PMID: 28714183 BACKGROUND

• 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.

  PMID: 26378641 BACKGROUND

• 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.

  PMID: 27484755 BACKGROUND

• 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.

  PMID: 35126843 BACKGROUND

• 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.

  PMID: 24098525 BACKGROUND

• 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.

  PMID: 21083855 BACKGROUND

• 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.

  PMID: 26156412 BACKGROUND

• 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.

  PMID: 30675881 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Diseases

Interventions

Rosuvastatin Calcium; Tablets; coenzyme Q10

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Hadeer Ahmed Alsayed, B.Sc. Degree

  Faculty of pharmacy , Pharos University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadeer Ahmed Alsayed, B.Sc. Degree

CONTACT

00201011611651; hader.ahmed41996@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: * 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

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 16, 2023
• Study Start: June 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05