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

March 19, 2025 updated by: Getz Pharma

Effects of Ertugliflozin on Liver Fat, Liver Fibrosis & Glycemic Control in Subjects With Type 2 Diabetes Mellitus (T2DM) & Non-Alcoholic Fatty Liver Disease /Non-Alcoholic Steatohepatitis

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan
        • Recruiting
        • North west general hospital
        • Contact:
          • Arshad Hussain, M.B.B.S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient able to provide written informed consent
  • Adult males & females between 18 to 65 years
  • SGLT2i and insulin naïve patients
  • BMI >23 Kg/m2
  • HbA1C % ≥ 6.5 to 10
  • Documented hepatic steatosis or fatty liver disease on Ultrasound
  • Patient with Type II Diabetes Mellitus

Exclusion Criteria:

  • 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.
  • History of uncontrolled Endocrine disorder (for example uncontrolled hypothyroidism, or that requires frequent dose adjustment, or Cushing's syndrome)
  • History of liver disease including viral hepatitis, auto-immune hepatitis, liver cirrhosis, hepatocellular carcinoma and/or HIV
  • History of recurrent UTIs and mycotic infection.
  • Severely ill patients (who have high grade fever, sepsis or acute infection)
  • Pregnant woman, lactating woman or planning pregnancy during study duration
  • History of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids (including homeopathic medicines).
  • History of active substance abuse (cannabinoid-derived substances like heroin, cocaine, amphetamines) based on history and/or laboratory tests
  • Alcohol intake 10 - 30 g/day (three drinks per day) within the previous year
  • Active substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine or amphetamines.
  • Severe hepatic impairment ( AST & ALT levels > 3 times upper limit normal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ertugliflozin
Ertugliflozin 5/15mg once daily with standard of care
Drug: Ertugliflozin 5 mg, 15mg
Ertugliflozin 5/15mg once daily in addition to standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiologic liver parameters
Time Frame: up to 24 weeks
Number of participants reported change in liver fat content from baseline, as quantified by fibroscan
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c% levels compare with baseline in 6 months
Time Frame: up to 24 weeks
Efficacy
up to 24 weeks
Change in body weight compare with baseline in 6 months
Time Frame: up to 24 weeks
Body Weight
up to 24 weeks
Change in waist circumference compare with baseline in 6 months
Time Frame: up to 24 weeks
Waist Circumference
up to 24 weeks
Fibrosis 4 score levels compare with baseline in 6 months
Time Frame: up to 24 weeks
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
Time Frame: up to 24 weeks

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
Time Frame: up to 24 weeks
Safety
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Getz Pharma

Investigators

  • Principal Investigator: Umar Raja, MBBS, Shifa International Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTZ_DM_007_22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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