Comparative Clinical Study Between Empagliflozin Versus Pioglitazone in Non-diabetic Patients With Non-alcoholic Steatohepatitis

NCT05605158 | Unknown Phase 3

• 1 other identifier: 35937/10/22
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the possible beneficial effect of empagliflozin versus pioglitazone on non-diabetic patients with non-alcoholic steatohepatitis (NASH). This study will be a randomized, comparative parallel study. The study will be conducted according to the ethical standards of Helsinki declaration in 1964 and its later amendments. The study duration will be 24 weeks. The patients will be randomized into two groups: Group 1: (Pioglitazone group; n=28) which will receive 30mg/day pioglitazone for 24 weeks. Group 2: (Empagliflozin group; n=28) which will receive 10mg/day empagliflozin for 24 weeks.

Conditions

Non Alcoholic Steatohepatitis

Keywords

NASH; Nonalcoholic fatty liver disease (NAFLD); SGLT2i; Empagliflozin; Pioglitazone; Hepatic steatosis index (HSI); Fibrosis index based on the 4 factors (FIB-4); Aspartate transaminase-to-platelet ratio index (APRI); Cytokeratin-18; Transforming growth factor-beta1 (TGF-β1); Malondialdehyde (MDA)

Outcome Measures

Primary Outcomes (3)

• Change in fibrosis index based on the 4 factors (FIB-4)

  FIB-4 will be calculated using the formula: FIB-4 = Age (years)× AST (IU/L)/\[platelet count (109/L) × ALT1/2 (IU/L)\].

  Baseline and 24th week

• Change in aspartate transaminase-to-platelet ratio index (APRI)

  APRI will be calculated using the formula: APRI = (AST (IU/L)/upper limit of normal AST range) X 100 /platelet count (109/L).

  Baseline and 24th week

• Change in liver enzymes

  Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Gamma-glutamyl transferase (GGT) will be determined by kinetic method.

  Baseline, 12th and 24th week

Secondary Outcomes (4)

• Cytokeratin-18 (CK-18)

  Baseline and 24th week

• Malondialdehyde (MDA)

  Baseline and 24th week

• Tumor necrosis factor-alpha (TNF-α)

  Baseline and 24th week

• Transforming growth factor-beta1 (TGF-β1)

  Baseline and 24th week

Study Arms (2)

Group 1 (Pioglitazone group; n=28)

ACTIVE COMPARATOR

Non-diabetic patients with non-alcoholic steatohepatitis will receive 30mg/day pioglitazone for 24 weeks.

Drug: Pioglitazone 30mg

Group 2 (Empagliflozin group; n=28)

ACTIVE COMPARATOR

Non-diabetic patients with non-alcoholic steatohepatitis will receive 10mg/day empagliflozin for 24 weeks.

Drug: Empagliflozin 10 MG

Interventions

Pioglitazone 30mg DRUG

Pioglitazone 30 mg will be administered orally once daily for 24 weeks.

Group 1 (Pioglitazone group; n=28)

Empagliflozin 10 MG DRUG

Empagliflozin 10 mg will be administered orally once daily for 24 weeks.

Group 2 (Empagliflozin group; n=28)

Eligibility Criteria

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

You may qualify if:

• Non-diabetic patients.
• Both males and females.
• Age \>18 years old.
• Patient with body mass index (BMI) \> 30 kg/m2.
• Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (\>2 but \<5 times upper limit of normal), hepatic steatosis index (HSI) \>36, and HAIR score of 2 or 3.

You may not qualify if:

• Patients with BMI \> 40 kg/m2.
• Patients with type 2 diabetes mellitus (T2DM) on the basis of a fasting plasma glucose (FPG) level ≥ 126 mg/dl (7mmol/L) or glycated hemoglobin (HbA1c) \> 6.5% (48 mmol/mol).
• Alcohol consumption greater than 20 g per day for women or greater than 30 g for men for at least three consecutive months over the past 5 years.
• History of viral hepatitis, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction, alpha-1 antitrypsin deficiency.
• Patients on medications interfere with lipid and carbohydrate metabolisms.
• Patients with heart failure (New York Heart Association (NYHA) class 2-4).
• Patients with history of cardiovascular events within the past 3 months.
• Patients with renal impairment (eGFR\> 45 mL/min/ 1.73 m2).
• Patients with cancer or with a history of cancer treatment over the past 2 years.
• Patients with thyroid disorder.
• Patients on medications associated with steatosis such as Non-steroidal anti-inflammatory drugs (NSAIDs), amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate.
• Patients with inflammatory diseases.
• Patients on supplements known to have antioxidant activity such as vitamin E, vitamin C, zinc, and selenium.
• Pregnant and breastfeeding women.
• Females on oral contraceptive pills will be also excluded.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31511, Egypt

Location

Related Publications (21)

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Camurati-Engelmann Syndrome

Interventions

Pioglitazone; empagliflozin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Aya El-nawasany, Bachelor Degree

CONTACT

00201110963270; ynawasany53@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

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 4, 2022
• Study Start: November 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

EG (1)