Comparative Clinical Study Between Empagliflozin Versus Pioglitazone in Non-diabetic Patients With Non-alcoholic Steatohepatitis
NCT05605158 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2022-11-04
Summary
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.
Conditions
- Non Alcoholic Steatohepatitis
Interventions
- DRUG
-
Pioglitazone 30mg
Pioglitazone 30 mg will be administered orally once daily for 24 weeks.
- DRUG
-
Empagliflozin 10 MG
Empagliflozin 10 mg will be administered orally once daily for 24 weeks.
Sponsors & Collaborators
-
Tanta University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-30
- Primary Completion
- 2023-05-31
- Completion
- 2024-11-30
Countries
- Egypt
Study Locations
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