Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519448
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Reducing Non-Alcoholic Steatohepatitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Reducing Non-Alcoholic Steatohepatitis Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RedNASH
Brief Summary:
The goal of this clinical trial is to learn if empagliflozin works to treat non-alcoholic steatohepatitis in adults The objectives are
Primary Objective To evaluate the change in histological grading and staging of NASH in patients with confirmed non-alcoholic steatohepatitis NASH treated with empagliflozin for a duration of 48 weeks
Secondary Objective To evaluate the change in findings from non-invasive liver elasticity measurements laboratory tests and anthropometric assessments after 48 weeks of empagliflozin administration
Participants will
Take empagliflozin every day for 12 months Visit the clinic according to a protocol at weeks 1 2 4 12 24 36 48 Visits includes checkups and tests blood count basic biochemistry glycosylated hemoglobin anthropometry non-invasive liver stiffness measurement
Primary Objective To evaluate the change in histological grading and staging of NASH in patients with confirmed non-alcoholic steatohepatitis NASH treated with empagliflozin for a duration of 48 weeks
Secondary Objective To evaluate the change in findings from non-invasive liver elasticity measurements laboratory tests and anthropometric assessments after 48 weeks of empagliflozin administration
Participants will
Take empagliflozin every day for 12 months Visit the clinic according to a protocol at weeks 1 2 4 12 24 36 48 Visits includes checkups and tests blood count basic biochemistry glycosylated hemoglobin anthropometry non-invasive liver stiffness measurement
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None