Liver FatPhase 4Ertu-NASHNCT05644717
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
A Phase 4 study testing Ertugliflozin 5 mg, 15mg in people with Liver Fat and Liver Fibrosis, run by Getz Pharma at 1 site in Pakistan.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Fat, Liver Fibrosis, Glycemic Control
- What is being tested?
- Ertugliflozin 5 mg, 15mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2023to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
North west general hospital
Peshawar, KPK
Arshad Hussain, M.B.B.S
About this study
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
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
- Being tested
- Ertugliflozin 5 mg, 15mg
- Medical subject headings
- Fatty Liver, Liver Cirrhosis, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ertugliflozin 5 mg, 15mgDrug
Ertugliflozin 5/15mg once daily in addition to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Ertugliflozin | Experimental | Ertugliflozin 5/15mg once daily with standard of care Receives: Drug: Ertugliflozin 5 mg, 15mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic liver parameters
Number of participants reported change in liver fat content from baseline, as quantified by fibroscan
Measured: up to 24 weeks
Secondary outcomes (6)
HbA1c% levels compare with baseline in 6 months
Efficacy
Measured: up to 24 weeks
Change in body weight compare with baseline in 6 months
Body Weight
Measured: up to 24 weeks
Change in waist circumference compare with baseline in 6 months
Waist Circumference
Measured: up to 24 weeks
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
Measured: up to 24 weeks
Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months
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
Measured: up to 24 weeks
Frequency of adverse events in 6 months
Safety
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Mar 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Umar Raja, MBBS, Principal investigator, Shifa International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644717
- Sponsor's protocol ID
- GTZ_DM_007_22
- Acronym
- Ertu-NASH
- Status last verified
- Mar 2025
- First submitted
- 18 Nov 2022
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29097281Targher 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.
PubMed 27212244Mantovani 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.
PubMed 29358469Mantovani 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.
PubMed 29137912Schuppan 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.
PubMed 23855299Gusdon 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.
PubMed 25371775
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05644717
- Acronym / sponsor ID
- Ertu-NASH / GTZ_DM_007_22
- Conditions
- Liver Fat, Liver Fibrosis, Glycemic Control, Body Weight Changes, Waist Circumference, Tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Getz PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ertugliflozin | Experimental | Drug: Ertugliflozin 5 mg, 15mgErtugliflozin 5/15mg once daily with standard of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ertugliflozin 5 mg, 15mgErtugliflozin 5/15mg once daily in addition to standard of care | Drug | Ertugliflozin |
Primary outcome
Radiologic liver parameters
Time frame: up to 24 weeks
Number of participants reported change in liver fat content from baseline, as quantified by fibroscan
6 secondary outcomes
HbA1c% levels compare with baseline in 6 months
Time frame: up to 24 weeks
Change in body weight compare with baseline in 6 months
Time frame: up to 24 weeks
Change in waist circumference compare with baseline in 6 months
Time frame: up to 24 weeks
Fibrosis 4 score levels compare with baseline in 6 months
Time frame: up to 24 weeks
Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months
Time frame: up to 24 weeks
Frequency of adverse events in 6 months
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 29097281Hu 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.
- Background: PubMed 27212244Targher 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.
- Background: PubMed 29358469Mantovani 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.
- Background: PubMed 29137912Mantovani 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.
- Background: PubMed 23855299Schuppan 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.
- Background: PubMed 25371775Gusdon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Umar Raja, MBBS principal investigator
Shifa International Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ertugliflozin 5 mg, 15mg in people with Liver Fat and Liver Fibrosis, run by Getz Pharma at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Nabeed Tahir, MBBS (+923015376299 ext. 2907, nabeedtahir@getzpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiologic liver parameters (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644717, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.