Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pioglitazone (PIO), Empagliflozin, Statin (Atorvastatin), Empagliflozin plus Statin (Atorvastatin).
- Who it may be relevant to
- Registry conditions: Non-alcoholic Fatty Liver Disease NAFLD, Non-alcoholic Steatohepatitis NASH. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Efficacy of Empagliflozin Versus Statins in Treatment of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis
Overview
The goal of this clinical trial is to assess the efficacy of Empagliflozin versus Statins as monotherapy and polytherapy in non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis. Does drug ABC Empagliflozin versus Statins as monotherapy and polytherapy improve the controlled attenuation parameter (CAP), the liver stiffness measurement (LSM), the proportion of patients with at least one point improvement or one-stage reduction in the histological scores with respect to hepatic steatosis, hepatocellular ballooning, lobular inflammation, and fibrosis after treatment? What medical problems do participants have when taking Empagliflozin versus Statins as monotherapy and polytherapy? Participants will: * Take Empagliflozin alone or Empagliflozin plus statins or Pioglitazone plus Statins or Pioglitazone alone as standard therapy every day for 3 months * Be directed to complete history taking. FibroScan®, abdominal ultrasound and laboratory tests of ALT, AST, ALP, platelets count, Triglycerides, Cholesterol, LDL, HDL, serum insulin and insulin resistance will be conducted at baseline and after the drug administration for 3 months. * Keep a diary of recording any side effects they use a rescue inhaler
Detailed description
NAFLD is a growing global health problem linked with metabolic issues like obesity, diabetes, and insulin resistance. It ranges from simple liver fat accumulation to NASH, involving inflammation and liver damage, progressing to fibrosis, cirrhosis, and cancer. Managing NAFLD is tough due to diagnosis challenges and metabolic complications. Lifestyle changes like diet and exercise are key but often hard to sustain. No FDA-approved treatments exist yet, but drugs like Empagliflozin and statins are being studied for their potential to improve insulin sensitivity, reduce liver inflammation, and slow disease progression. This study compares these therapies for NAFLD and NASH.
Interventions
- Drug Pioglitazone (PIO)
30 mg orally once daily - Drug Empagliflozin
10 mg orally once daily - Drug Statin (Atorvastatin)
20 mg orally once daily - Drug Empagliflozin plus Statin (Atorvastatin)
Orally once daily of each (10 mg, 20 mg respectively) - Drug Pioglitazone plus Atorvastatin
Orally once daily of each (30mg and 20mg respectively)
Primary outcome measures
- The controlled attenuation parameter (CAP). [Time frame: After 3 months]
- The liver stiffness measurement (LSM) using FibroScan®. [Time frame: After 3 months]
Secondary outcome measures (1)
- Fibrosis-4 (FIB-4) index [Time frame: After 3 months]
Eligibility criteria
Inclusion criteria
- Adult
- Obese
- Hyperlipidemic
- Diabetic patients
- Diagnosed with non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis
Exclusion criteria
- Pregnant women
- Breast feeding women
- Diabetic patients with ketoacidosis
- Hyperlipidemic patients with cardiovascular dysfunction
- Patients with NAFLD or NASH induced hepatocellular carcinoma
- Hyperlipidemic obese diabetic patients diagnosed with NAFLD or NASH who will refuse to sign the informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Teaching hospital of Beni Suef University — Banī Suwayf
Identifiers
NCT: NCT07180745 · FMBSUREC/01092024