NCT05644717 Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
| NCT ID | NCT05644717 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Getz Pharma |
| Condition | Liver Fat |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 164 participants in total. It began in 2023-03-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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
Contact & Investigator
Umar Raja, MBBS
PRINCIPAL INVESTIGATOR
Shifa International Hospital
Frequently Asked Questions
Who can join the NCT05644717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Liver Fat. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05644717 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05644717 currently recruiting?
Yes, NCT05644717 is actively recruiting participants. Contact the research team at nabeedtahir@getzpharma.com for enrollment information.
Where is the NCT05644717 trial being conducted?
This trial is being conducted at Peshawar, Pakistan.
Who is sponsoring the NCT05644717 clinical trial?
NCT05644717 is sponsored by Getz Pharma. The principal investigator is Umar Raja, MBBS at Shifa International Hospital. The trial plans to enroll 164 participants.