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NCT Number: NCT05644717

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

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)

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

North west general hospital

Peshawar, KPK, Pakistan

Location status: Recruiting

Location contact

Arshad Hussain, M.B.B.S

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ertugliflozin 5 mg, 15mg

Drug

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

Primary outcomes

  1. Radiologic liver parameters

    Time frame: up to 24 weeks

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

Secondary outcomes

  1. HbA1c% levels compare with baseline in 6 months

    Time frame: up to 24 weeks

    Efficacy

  2. Change in body weight compare with baseline in 6 months

    Time frame: up to 24 weeks

    Body Weight

  3. Change in waist circumference compare with baseline in 6 months

    Time frame: up to 24 weeks

    Waist Circumference

  4. 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

  5. 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

  6. Frequency of adverse events in 6 months

    Time frame: up to 24 weeks

    Safety

Study contacts

Contact information is provided by the study sponsor or research team.

Jahanzeb Kamal Khan, MBBS

CONTACT

[email protected]

+923201212945 ext. 8386

Muhammad Nabeed Tahir, MBBS

CONTACT

[email protected]

+923015376299 ext. 2907

Sponsors and collaborators

Lead sponsor

Getz Pharma

Industry

Registry information

Official study 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

Acronym: Ertu-NASH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2022
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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