Henagliflozin on Liver Fibrosis in Patients with MASLD and T2DM

Xiqiao Zhou

Status and phase: Not yet enrolling; Phase 4

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease; Type 2 Diabetes Mellitus

Treatments: Other: Placebo of Henagliflozin; Drug: Metformin 1700 mg daily; Drug: Henagliflozin 10 mg daily

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06762223

2024NL-195-01

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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190 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Placebo + Metformin 1.7g/d

Treatment:

Drug: Metformin 1700 mg daily

Other: Placebo of Henagliflozin

Intervention Group

Experimental group

Description:

Henagliflozin 10mg/d + Metformin 1.7g/d

Treatment:

Drug: Henagliflozin 10 mg daily

Drug: Metformin 1700 mg daily