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

Sponsor
Tanta University
Study ID
NCT05605158
Phase
PHASE3
Status
Unknown

Conditions

  • Non Alcoholic Steatohepatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pioglitazone 30mg — DRUG
    Pioglitazone 30 mg will be administered orally once daily for 24 weeks.
  • Empagliflozin 10 MG — DRUG
    Empagliflozin 10 mg will be administered orally once daily for 24 weeks.

Study Details

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.

Key Dates

Start date
Nov 30, 2022
Status verified
Nov 2022
Primary completion
May 31, 2023
Completion
Nov 30, 2024

Study Design

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

Arms

  • Active Comparator: Group 1 (Pioglitazone group; n=28)
    Non-diabetic patients with non-alcoholic steatohepatitis will receive 30mg/day pioglitazone for 24 weeks.
  • Active Comparator: Group 2 (Empagliflozin group; n=28)
    Non-diabetic patients with non-alcoholic steatohepatitis will receive 10mg/day empagliflozin for 24 weeks.

Primary Outcome Measure

Change in fibrosis index based on the 4 factors (FIB-4) [ Time Frame: Baseline and 24th week ]

Central Contacts

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