Henagliflozin Tested for Liver Scarring in Diabetes and Fatty Liver
Tests henagliflozin against placebo in adults with fatty liver disease and type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Henagliflozin on Liver Fibrosis in Patients with MASLD and T2DM
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with fatty liver disease linked to metabolism (MASLD) and type 2 diabetes who have stiff liver tissue on a FibroScan test.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- MASLD and type 2 diabetes (T2DM), with HbA1c between 6.5% (48 mmol/mol) and 9% (75 mmol/mol), and liver stiffness (FibroScan LSM) of 8 kPa or higher.
- Earlier treatment
- No diabetes medicines other than biguanides in the 3 months before the trial. No medicines that can cause or improve fatty liver or liver scarring in the past 3 months.
- Biomarker or test result
- FibroScan liver stiffness of 8 kPa or higher; HbA1c between 6.5% (48 mmol/mol) and 9% (75 mmol/mol).
Main reasons for not taking part
- Other liver diseases such as viral hepatitis, autoimmune liver disease, liver tumors or drug-induced liver injury
- ALT or AST levels 3 times the normal range or higher
- Heavy alcohol use (women over 12 grams per day, men over 24 grams per day)
- Weight-loss (bariatric) surgery, or pregnant or breastfeeding women
- Severe recurrent urinary or genital tract infections
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06762223, who can take part
Where in China
- Jiangsu Province Hospital of Traditional Chinese MedicineNanjing, ChinaContact: Jiangsu province hospital of traditional chinese medicineNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xiqiao Zhou
- Trial code
- NCT06762223
- Record updated
- 7 January 2025
- Original description
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.Read full original descriptionShow less
Intervention of Henagliflozin on Liver Fibrosis in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) and Type 2 Diabetes Mellitus (T2DM)
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.
Inclusion: 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.
Exclusion: 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; 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; Individuals exhibiting ALT and/or AST levels that exceed the normal range by threefold or more; 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.