Effects of a GLP-1 analogue on liver fat in patients with Type 2 diabetes and fatty liver disease
Effect on Non-Alcoholic Fatty Liver Disease With Advanced Fibrosis in Patients With Type 2 Diabetes Mellitus on Treatment With Gastric Inhibitory Polypeptide / Glucagon Like Peptide-1 Analogue (Tirzpatide)
This study is testing if a new diabetes medication can help reduce liver fat in people with Type 2 diabetes and fatty liver disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | United Arab Emirates University Academic / other |
| Locations | 1 site (Al Ain, Abu Dhabi) |
| Trial ID | NCT05751720 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a GLP-1 analogue on liver fat deposition in patients diagnosed with Type 2 Diabetes Mellitus and advanced fibrosis due to Non-Alcoholic Fatty Liver Disease (NAFLD). The study aims to enroll participants who have been living with Type 2 diabetes for over a year and have not previously been treated with GLP-1 analogues or certain other diabetes medications. Participants will receive the treatment for six months, after which the effects on liver fat will be assessed. This is the first randomized study focusing on this treatment approach within the United Arab Emirates population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with Type 2 Diabetes Mellitus for more than one year and advanced fibrosis due to NAFLD.
Not a fit: Patients with known liver diseases, significant alcohol use, or those currently on specific diabetes medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce liver fat and improve liver health in patients with Type 2 diabetes and fatty liver disease.
How similar studies have performed: While this approach is novel in the UAE, similar studies in other regions have shown promising results in treating NAFLD with GLP-1 analogues.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18; either male or female * Diagnosed to have Type 2 Diabetes Mellitus for \> 1 year. * Presence of NAFLD advanced fibrosis (F3 and F4; defined by NFS of \> 0.676) * Able to consent independently * Not already on GLP-1 analogues or SGLT2 inhibitors or pioglitazone * Good general health * BMI\> 19 but less than 40 Exclusion Criteria: * Known history of alcohol excess or current alcohol use of \> 20 g/week * Evidence of pre-existing liver or biliary disease (hepatoma, biliary tract obstruction; liver cirrhosis secondary to viral infection or immune/ congenital). * Known or suspected hypersensitivity to GLP-1 analogues or pioglitazone. * Receipt of any investigational medicinal product within 30 days before screening. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods. * Endocrinopathies (e.g., Cushing syndrome) * Personal history of heart disease especially heart failure * History of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed. * eGFR \< 30 * history of heamturia or bladder cancer * history of osteoporosis * ALT ≥3.5 times the upper normal limit (UNL) * Taking steroids, antipsychotics or progesterone preparations * Uncontrolled hypertension * Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies. * HbA1c \> 10% * Claustrophobia or unable to get MRI due to contraindications (e.g metal in the body) * Weight \> 150 kg (due to imaging trolley restrictions)
Where this trial is running
Al Ain, Abu Dhabi
- Internal Medicine, College of Medicine and Health Sciences — Al Ain, Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: Adnan Agha, FRCP — United Arab Emirates University, College of Medicine & Health Sciences
- Study coordinator: Adnan Agha, FRCP
- Email: adnanagha@uaeu.ac.ae
- Phone: +971-3-7673333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.