Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-03-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Non-alcoholic Fatty Liver Disease NAFLD Non-alcoholic Steatohepatitis NASH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Orally once daily of each (30mg and 20mg respectively)

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No