Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

Sponsor
Badr University
Study ID
NCT07180745
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Pioglitazone (PIO) — DRUG
    30 mg orally once daily
  • Empagliflozin — DRUG
    10 mg orally once daily
  • Statin (Atorvastatin) — DRUG
    20 mg orally once daily
  • Empagliflozin plus Statin (Atorvastatin) — DRUG
    Orally once daily of each (10 mg, 20 mg respectively)
  • Pioglitazone plus Atorvastatin — DRUG
    Orally once daily of each (30mg and 20mg respectively)

Study Details

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

Key Dates

Start date
Nov 1, 2025
Status verified
Sep 2025
Primary completion
Feb 1, 2026
Completion
Mar 1, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pioglitazone
    30 mg once daily orally for 3 months
  • Active Comparator: Empagliflozin
    10 mg once daily orally for 3 months
  • Active Comparator: Statins
    Once daily orally for 3 months
  • Active Comparator: Empagliflozin plus statins
    Once daily orally for 3 months
  • Active Comparator: Pioglitazone plus Statins
    Once daily orally for 3 months

Primary Outcome Measure

The controlled attenuation parameter (CAP). [ Time Frame: After 3 months ]

Central Contacts