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Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD

ConditionsLiver FatLiver FibrosisGlycemic ControlBody Weight ChangesWaist CircumferenceTolerance
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGetz Pharma

About this trial

Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis \& glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient able to provide written informed consent

Adult males & females between 18 to 65 years

SGLT2i and insulin naïve patients

BMI >23 Kg/m2

Disqualifiers

History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study.

Pioglitazone use in the past 6 months

History of vitamin E use (400mg twice daily) 3 months prior to enrollment in the study.

History of anti-obesity medication or weight loss procedure (bariatric surgery) use within 3 months prior to enrollment in the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ertugliflozin 5 mg, 15mg

    Drug

    Ertugliflozin 5/15mg once daily in addition to standard of care

Treatment groups

164 Participants
are divided into 1 treatment group
Group A: ErtugliflozinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Radiologic liver parameters

Number of participants reported change in liver fat content from baseline, as quantified by fibroscan

Time frame
up to 24 weeks

Secondary outcomes

1

HbA1c% levels compare with baseline in 6 months

Efficacy

Time frame
up to 24 weeks
2

Change in body weight compare with baseline in 6 months

Body Weight

Time frame
up to 24 weeks
3

Change in waist circumference compare with baseline in 6 months

Waist Circumference

Time frame
up to 24 weeks
4

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

Time frame
up to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Getz Pharma

Lead sponsor

Source ClinicalTrials.gov
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