NCT06762223Not yet recruitingPhase 4
Henagliflozin on Liver Fibrosis in Patients with MASLD and T2DM
Intervention of Henagliflozin on Liver Fibrosis in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) and Type 2 Diabetes Mellitus (T2DM)
Source: ClinicalTrials.gov · Last updated 7 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) is increasing due to changes in economic conditions and lifestyle, and it is anticipated to become a significant liver disease burden in the future. This is particularly true for patients with MASLD who also have type 2 diabetes mellitus (T2DM), as the rate of comorbidity between these conditions has risen in recent years due to their shared mechanisms, necessitating careful management of both. Liver fibrosis is a critical concern, as poor blood glucose control can worsen liver fibrosis, which in turn complicates blood sugar management. Therefore, addressing liver fibrosis in patients with MASLD and T2DM is urgent, yet there are currently no targeted therapies to reverse its progression. SGLT2 inhibitors, have shown promise in potentially reversing liver fibrosis, but existing research is limited and has not adequately focused on liver fibrosis improvement, highlighting the need for more robust evidence-based studies.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- First submitted
- 17 Dec 2024
- Start date
- 31 Dec 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Xiqiao Zhou
- NCT number
- NCT06762223
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 190
- From 31 Dec 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently using or having used medications associated with secondary MASLD (including, but not limited to, corticosteroids, estrogen, amiodarone, methotrexate, etc.) within the preceding three months;
- Individuals utilizing or having utilized medications within the last three months that possess the potential to ameliorate hepatic steatosis or fibrosis in MASLD (including, but not limited to, ursodeoxycholic acid, bicyclol tablets, silymarin capsules, polyene phosphatidylcholine capsules, vitamin E, etc.);
- Patients with known or suspected elevated alcohol consumption (females exceeding 12 grams per day; males exceeding 24 grams per day) or those on medications that may contribute to increased consumption;
- Individuals who have experienced severe acute complications such as hypoglycemia, ketoacidosis, hyperglycemia, or hyperosmolar states within the past month or during the course of medication;
- Patients who have undergone metabolic bariatric surgery or are currently participating in bariatric treatment;
Other illness
- Patients diagnosed with non-MASLD, which encompasses conditions such as viral hepatitis, autoimmune liver disease, liver tumors, and drug-induced liver injury, among others;
- Individuals with significant primary systemic pathologies, including but not limited to respiratory, circulatory, digestive, urinary, neurological, hematological, rheumatological, endocrine diseases, tumors, or AIDS;
- Individuals with known allergies or potential allergies to the medications utilized in this study, rendering them intolerant;
- Patients with a history of recurrent or severe urinary and genital tract infections;
- Individuals exhibiting severe cognitive impairment or mental illness that impedes their ability to cooperate;
Lab values
- Individuals exhibiting ALT and/or AST levels that exceed the normal range by threefold or more;
Other
- Female participants who are pregnant, breastfeeding, or of childbearing potential and not employing a highly effective contraceptive method;
- Patients currently engaged in clinical observation of other pharmacological agents.
Who the study is looking for
- Participants must be aged between 18 and 75 years.
- Participants must meet the diagnostic criteria for MASLD and T2DM.
- Participants' HbA1c level between 6.5% and 9%.
- The LSM obtained via the FibroScan device must be equal to or greater than 8 kPa.
- Participants must not have experienced a significant change in body weight exceeding 15% within the past four weeks.
- Participants must not have utilized non-biguanide hypoglycemic medications in the three months preceding the study.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiangsu Province Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.