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

NCT05644717 | Recruiting Phase 4

• 1 other identifier: GTZ_DM_007_22
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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)

Conditions

Liver Fat; Liver Fibrosis; Glycemic Control; Body Weight Changes; Waist Circumference; Tolerance

Outcome Measures

Primary Outcomes (1)

• Radiologic liver parameters

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

  up to 24 weeks

Secondary Outcomes (6)

• HbA1c% levels compare with baseline in 6 months

  up to 24 weeks

• Change in body weight compare with baseline in 6 months

  up to 24 weeks

• Change in waist circumference compare with baseline in 6 months

  up to 24 weeks

• Fibrosis 4 score levels compare with baseline in 6 months

  up to 24 weeks

• Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months

  up to 24 weeks

Study Arms (1)

Ertugliflozin

EXPERIMENTAL

Ertugliflozin 5/15mg once daily with standard of care

Drug: Ertugliflozin 5 mg, 15mg

Interventions

Ertugliflozin 5 mg, 15mg DRUG

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

Ertugliflozin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Getz Pharma: lead

Study Sites (1)

North west general hospital

Peshawar, KPK, Pakistan

RECRUITING

Related Publications (6)

• Hu M, Phan F, Bourron O, Ferre P, Foufelle F. Steatosis and NASH in type 2 diabetes. Biochimie. 2017 Dec;143:37-41. doi: 10.1016/j.biochi.2017.10.019. Epub 2017 Oct 31.

  PMID: 29097281 BACKGROUND

• Targher G, Byrne CD, Lonardo A, Zoppini G, Barbui C. Non-alcoholic fatty liver disease and risk of incident cardiovascular disease: A meta-analysis. J Hepatol. 2016 Sep;65(3):589-600. doi: 10.1016/j.jhep.2016.05.013. Epub 2016 May 17.

  PMID: 27212244 BACKGROUND

• Mantovani A, Byrne CD, Bonora E, Targher G. Nonalcoholic Fatty Liver Disease and Risk of Incident Type 2 Diabetes: A Meta-analysis. Diabetes Care. 2018 Feb;41(2):372-382. doi: 10.2337/dc17-1902.

  PMID: 29358469 BACKGROUND

• Mantovani A, Zaza G, Byrne CD, Lonardo A, Zoppini G, Bonora E, Targher G. Nonalcoholic fatty liver disease increases risk of incident chronic kidney disease: A systematic review and meta-analysis. Metabolism. 2018 Feb;79:64-76. doi: 10.1016/j.metabol.2017.11.003. Epub 2017 Nov 11.

  PMID: 29137912 BACKGROUND

• Schuppan D, Schattenberg JM. Non-alcoholic steatohepatitis: pathogenesis and novel therapeutic approaches. J Gastroenterol Hepatol. 2013 Aug;28 Suppl 1:68-76. doi: 10.1111/jgh.12212.

  PMID: 23855299 BACKGROUND

• Gusdon AM, Song KX, Qu S. Nonalcoholic Fatty liver disease: pathogenesis and therapeutics from a mitochondria-centric perspective. Oxid Med Cell Longev. 2014;2014:637027. doi: 10.1155/2014/637027. Epub 2014 Oct 13.

  PMID: 25371775 BACKGROUND

MeSH Terms

Conditions

Fatty Liver; Liver Cirrhosis; Body Weight Changes

Interventions

ertugliflozin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight; Signs and Symptoms

Study Officials

• Umar Raja, MBBS

  Shifa International Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Nabeed Tahir, MBBS

CONTACT

+923015376299; nabeedtahir@getzpharma.com

Jahanzeb Kamal Khan, MBBS

CONTACT

+923201212945; jahanzeb.kamal@getzpharma.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 9, 2022
• Study Start: March 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)