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Clinical Trial Details

Trial ID: L4502
Source ID: NCT05644717
Associated Drug: Ertugliflozin 5 Mg, 15mg
Title: Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
Acronym: Ertu-NASH
Status: RECRUITING
Study Results: NO
Results:
Conditions: Liver Fat|Liver Fibrosis|Glycemic Control|Body Weight Changes|Waist Circumference|Tolerance
Interventions: DRUG: Ertugliflozin 5 mg, 15mg
Outcome Measures: Primary: Radiologic liver parameters, Number of participants reported change in liver fat content from baseline, as quantified by fibroscan, up to 24 weeks | Secondary: HbA1c% levels compare with baseline in 6 months, Efficacy, up to 24 weeks|Change in body weight compare with baseline in 6 months, Body Weight, up to 24 weeks|Change in waist circumference compare with baseline in 6 months, Waist Circumference, up to 24 weeks|Fibrosis 4 score levels compare with baseline in 6 months, Fibrosis Scoring \< 1.45 indicates Fibrosis Stage 0-2, 1.45 to 3.25 is deemed indeterminate fibrosis stage, \> 3.25 indicates Fibrosis stage 3-4, up to 24 weeks|Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months, Non-Alchoholic Fatty Liver Disease Fibrosis Scoring, \< -1.455 indicates Fibrosis Stage 0-2, -1.455 to 0.676 is considered indeterminate fibrosis stage, \> 0.676 indicates Fibrosis Stage 3-4, up to 24 weeks|Frequency of adverse events in 6 months, Safety, up to 24 weeks
Sponsor/Collaborators: Sponsor: Getz Pharma
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 164
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-01
Completion Date: 2025-12-01
Results First Posted:
Last Update Posted: 2025-03-21
Locations: North west general hospital, Peshawar, KPK, Pakistan
URL: https://clinicaltrials.gov/show/NCT05644717