Henagliflozin on Liver Fibrosis in Patients with MASLD and T2DM (NCT06762223) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Henagliflozin on Liver Fibrosis in Patients with MASLD and T2DM
China190 participantsStarted 2024-12-31
Plain-language summary
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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Participants must be aged between 18 and 75 years.
ā. Participants must meet the diagnostic criteria for MASLD and T2DM.
ā. Participants' HbA1c level between 6.5% and 9%.
ā. The LSM obtained via the FibroScan device must be equal to or greater than 8 kPa.
ā. Participants must not have experienced a significant change in body weight exceeding 15% within the past four weeks.
ā. Participants must not have utilized non-biguanide hypoglycemic medications in the three months preceding the study.
Exclusion criteria
ā. Patients diagnosed with non-MASLD, which encompasses conditions such as viral hepatitis, autoimmune liver disease, liver tumors, and drug-induced liver injury, among others;
ā. Individuals exhibiting ALT and/or AST levels that exceed the normal range by threefold or more;
ā. 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;
What they're measuring
1
Liver stiffness measurements (LSM) of subjects
Timeframe: From enrollment to the treatment at 24 and 48 weeks
Trial details
NCT IDNCT06762223
SponsorXiqiao Zhou
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-12-31
Contact for this trial
Tiansu Jiangsu province hospital of traditional chinese medicine
ā. 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.);
ā. 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;
ā. 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;
ā. Patients who have undergone metabolic bariatric surgery or are currently participating in bariatric treatment;
ā. Individuals with significant primary systemic pathologies, including but not limited to respiratory, circulatory, digestive, urinary, neurological, hematological, rheumatological, endocrine diseases, tumors, or AIDS;