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

Sponsor
Getz Pharma (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05644717
Collaborator
(none)
164
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Ertugliflozin 5 mg, 15mg
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
164 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Radiologic liver parameters [up to 24 weeks]

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

Secondary Outcome Measures

  1. HbA1c% levels compare with baseline in 6 months [up to 24 weeks]

    Efficacy

  2. Change in body weight compare with baseline in 6 months [up to 24 weeks]

    Body Weight

  3. Change in waist circumference compare with baseline in 6 months [up to 24 weeks]

    Waist Circumference

  4. Fibrosis 4 score levels compare with baseline in 6 months [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

  5. Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months [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

  6. Frequency of adverse events in 6 months [up to 24 weeks]

    Safety

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Getz Pharma

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Getz Pharma
ClinicalTrials.gov Identifier:
NCT05644717
Other Study ID Numbers:
  • GTZ_DM_007_22
First Posted:
Dec 9, 2022
Last Update Posted:
Dec 9, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Body Weight
Body Weight Changes
Ertugliflozin

Study Results

No Results Posted as of Dec 9, 2022