Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

Badr University

Status and phase: Not yet enrolling; Phase 4

Conditions: Non-alcoholic Steatohepatitis NASH; Non-alcoholic Fatty Liver Disease NAFLD

Treatments: Drug: Pioglitazone plus Atorvastatin; Drug: Empagliflozin; Drug: Pioglitazone (PIO); Drug: Empagliflozin plus Statin (Atorvastatin); Drug: Statin (Atorvastatin)

Study type: Interventional

Funder types: Other

Identifiers

NCT07180745

FMBSUREC/01092024

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 5 patient groups

Pioglitazone

Active Comparator group

Description:

30 mg once daily orally for 3 months

Treatment:

Drug: Pioglitazone (PIO)

Empagliflozin

Active Comparator group

Description:

10 mg once daily orally for 3 months

Treatment:

Drug: Empagliflozin

Statins

Active Comparator group

Description:

Once daily orally for 3 months

Treatment:

Drug: Statin (Atorvastatin)

Empagliflozin plus statins

Active Comparator group

Description:

Once daily orally for 3 months

Treatment:

Drug: Empagliflozin plus Statin (Atorvastatin)

Pioglitazone plus Statins

Active Comparator group

Description:

Once daily orally for 3 months

Treatment:

Drug: Pioglitazone plus Atorvastatin