Clinical trial NCT06762223: Henagliflozin on Liver Fibrosis in Patients with MASLD and T2DM
Official title: Intervention of Henagliflozin on Liver Fibrosis in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) and Type 2 Diabetes Mellitus (T2DM)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
Type 2 Diabetes Mellitus
Keywords: metabolic dysfunction-associated steatotic liver disease
type 2 diabetes mellitus
Henagliflozin
SGLT2i
Liver fibrosis
Lead sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Jiangsu Hengrui Pharmaceutical Co., Ltd.
First posted: 2025-01-07
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Participants must be aged between 18 and 75 years.
2. Participants must meet the diagnostic criteria for MASLD and T2DM.
3. Participants' HbA1c level between 6.5% and 9%.
4. The LSM obtained via the FibroScan device must be equal to or greater than 8 kPa.
5. Participants must not have experienced a significant change in body weight exceeding 15% within the past four weeks.
6. Participants must not have utilized non-biguanide hypoglycemic medications in the three months preceding the study.

Exclusion Criteria:

1. Patients diagnosed with non-MASLD, which encompasses conditions such as viral hepatitis, autoimmune liver disease, liver tumors, and drug-induced liver injury, among others;
2. Individuals exhibiting ALT and/or AST levels that exceed the normal range by threefold or more;
3. 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;
4. 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.);
5. 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;
6. 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;
7. Patients who have undergone metabolic bariatric surgery or are currently participating in bariatric treatment;
8. Individuals with significant primary systemic pathologies, including but not limited to respiratory, circulatory, digestive, urinary, neurological, hematological, rheumatological, endocrine diseases, tumors, or AIDS;
9. Female participants who are pregnant, breastfeeding, or of childbearing potential and not employing a highly effective contraceptive method;
10. Individuals with known allergies or potential allergies to the medications utilized in this study, rendering them intolerant;
11. Patients with a history of recurrent or severe urinary and genital tract infections;
12. Individuals exhibiting severe cognitive impairment or mental illness that impedes their ability to cooperate;
13. Patients currently engaged in clinical observation of other pharmacological agents.

Primary outcomes:
measure: Liver stiffness measurements (LSM) of subjects
timeFrame: From enrollment to the treatment at 24 and 48 weeks
Secondary outcomes:
measure: Efficacy Evaluation of MASLD in fibrosis
timeFrame: From enrollment to the treatment at 24 and 48 weeks
measure: Efficacy Evaluation of MASLD in liver fatty quantification
timeFrame: From enrollment to the treatment at 24 and 48 weeks
measure: Efficacy Evaluation of MASLD in non-invasive biological indicators related to liver fibrosis
timeFrame: From enrollment to the treatment at 24 and 48 weeks
measure: Renal function
timeFrame: From enrollment to the treatment at 24 and 48 weeks
measure: Liver function
timeFrame: From enrollment to the treatment at 24 and 48 weeks
measure: Lipid metabolism
timeFrame: From enrollment to the treatment at 24 and 48 weeks
measure: Efficacy Evaluation of T2DM
timeFrame: From enrollment to the treatment at 24 and 48 weeks
measure: Efficacy Evaluation of T2DM
timeFrame: From enrollment to the treatment at 24 and 48 weeks
measure: Efficacy Evaluation of T2DM
timeFrame: From enrollment to the treatment at 24 and 48 weeks
measure: Efficacy Evaluation of T2DM
timeFrame: From enrollment to the treatment at 24 and 48 weeks
measure: Efficacy Evaluation of T2DM
timeFrame: From enrollment to the treatment at 24 and 48 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu province hospital of traditional chinese medicine
state: Jiangsu
Study officials:
References: