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Metabolic Dysfunction-associated Steatotic Liver DiseasePhase 4NCT06762223

Henagliflozin on Liver Fibrosis in Patients with MASLD and T2DM

A Phase 4 study testing Henagliflozin 10 mg daily and Metformin 1700 mg daily in people with Metabolic Dysfunction-associated Steatotic Liver Disease and Type 2 Diabetes Mellitus, run by Xiqiao Zhou at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Henagliflozin 10 mg daily and Metformin 1700 mg daily
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
190 participants
Where
1 siteChina
Study dates
31 Dec 2024to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 exhibiting ALT and/or AST levels that exceed the normal range by threefold or more;
  • 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;
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  • Patients who have undergone metabolic bariatric surgery or are currently participating in bariatric treatment;
  • Individuals with significant primary systemic pathologies, including but not limited to respiratory, circulatory, digestive, urinary, neurological, hematological, rheumatological, endocrine diseases, tumors, or AIDS;
  • Female participants who are pregnant, breastfeeding, or of childbearing potential and not employing a highly effective contraceptive method;
  • 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;
  • Patients currently engaged in clinical observation of other pharmacological agents.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tiansu Jiangsu province hospital of traditional chinese medicine contact

025-17397952085

728294997@qq.com

TIANSU LV, - contact

025+17397952085

China1 site

  • Jiangsu province hospital of traditional chinese medicine

    Nanjing, Jiangsu, 210029

    Jiangsu province hospital of traditional chinese medicine, 025-17397952085, 7282894997@qq.com

Other trials in China

About this study

Official title: 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.

Being tested
Henagliflozin 10 mg daily, Metformin 1700 mg daily, Placebo of Henagliflozin
Keywords
metabolic dysfunction-associated steatotic liver disease, type 2 diabetes mellitus, Henagliflozin, SGLT2i, Liver fibrosis
Medical subject headings
Diabetes Mellitus, Type 2, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Henagliflozin 10 mg dailyDrug

    Henagliflozin (SHR3824) is a hypoglycemic agent classified as an SGLT2i, which has been independently developed by Jiangsu Hengrui Pharmaceutical Co., Ltd. (China) and Shanghai Hengrui Pharmaceutical Co., Ltd (China). It received marketing authorization in China on December 31, 2021 (ID: H20210053).The prescribed dosage of Henagliflozin is 10 mg per day, as indicated on the drug label, with administration recommended in the early morning. In instances where a participant forgot to take the medication in the morning, they were permitted to do so until 12:00 PM on the same day.

  • Metformin 1700 mg dailyDrug

    The metformin utilized in this study is Metformin Hydrochloride Extended-release Tablets, manufactured by Bristol-Myers Squibb Company. This formulation of metformin is available in a dosage of 0.85 grams per tablet, necessitating that patients administer two tablets daily to acquire the dose of 1.7g daily, to be taken within thirty minutes prior to breakfast and dinner respectively. However, adjustments to the metformin dosage were not permitted during follow-up visits.

  • Placebo of HenagliflozinOther

    The placebo was supplied by the pharmaceutical company responsible for Henagliflozin, ensuring that both the placebo and Henagliflozin were indistinguishable in terms of appearance, taste, and odor, while lacking any significant pharmacological effect. Administration of the placebo was recommended to occur in the early morning.

Study groups in NCT06762223
Study groupRoleWhat they receive
Control GroupPlacebo comparatorPlacebo + Metformin 1.7g/d
Receives: Drug: Metformin 1700 mg daily; Other: Placebo of Henagliflozin
Intervention GroupExperimentalHenagliflozin 10mg/d + Metformin 1.7g/d
Receives: Drug: Henagliflozin 10 mg daily; Drug: Metformin 1700 mg daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Liver stiffness measurements (LSM) of subjects

    As determined by magnetic resonance elastography (MRE)

    Measured: From enrollment to the treatment at 24 and 48 weeks

Secondary outcomes (11)

  1. Efficacy Evaluation of MASLD in fibrosis

    This includes:

    1. Difference from baseline in LSM of subjects based on FibroScan;
    2. The proportion of LSM of subjects on MRE reduced by ≥15%;
    3. The proportion of LSM of subjects on FibroScan reduced by ≥15%

    Measured: From enrollment to the treatment at 24 and 48 weeks

  2. Efficacy Evaluation of MASLD in liver fatty quantification

    This includes:

    1. Difference from baseline in liver fatty quantification of subjects based on magnetic resonance imaging proton density fat fraction(MRI-PDFF);
    2. Difference from baseline in liver fatty quantification of subjects based on FibroScan;
    3. The proportion of liver fatty quantification of subjects based on MRI-PDFF was reduced by ≥30%;
    4. The proportion of liver fatty quantification of subjects based on FibroScan was reduced by ≥30%;

    Measured: From enrollment to the treatment at 24 and 48 weeks

  3. Efficacy Evaluation of MASLD in non-invasive biological indicators related to liver fibrosis

    This includes:1.NAFLD fibrosis score(NFS) = - 1.675 + [0.037 ×Age] + [0.094 × body mass index(BMI) (kg/m2)] + [1.13 × fasting plasma glucose(FPG)/ Diabetes (Yes=1，No= 0)] + [0.99 × aspartate aminotransferase(AST)/alanine aminotransferase(ALT)] - [0.013 × platelet count(PLT) (×109/L)] - [0.66 × Albumin(ALB) (g/dL)]; NFS <-1.455, -1.455-0.675, and >0.675 mean expressed as low, medium, and high risk, respectively(39); 2.Fibrosis-4(FIB-4) index= [Age× AST (U/L)]/[PLT (×109/L)× ALT (U/L)1/2];

    Measured: From enrollment to the treatment at 24 and 48 weeks

  4. Renal function

    This includes:This includes:Difference from baseline in renal function related parameters of subjects, primarily including uric acid(UA), urea nitrogen(BUN), creatinine(Cr), urine albumin-to-creatinine ratio(UACR).

    Measured: From enrollment to the treatment at 24 and 48 weeks

  5. Liver function

    This includes:Difference from baseline in liver function related parameters of subjects, primarily including AST, ALT, gamma-glutamyl transferase(GGT), alkaline phosphatase(ALP), ALB, total bilirubin(TBiL).

    Measured: From enrollment to the treatment at 24 and 48 weeks

  6. Lipid metabolism

    This includes:Difference from baseline in lipid metabolism related parameters of subjects, primarily including Triglyceride(TG), total cholesterol(TC), low-density lipoprotein cholesterol(LDL-C), high-density lipoprotein cholesterol(HDL-C).

    Measured: From enrollment to the treatment at 24 and 48 weeks

  7. Efficacy Evaluation of T2DM

    FPG

    Measured: From enrollment to the treatment at 24 and 48 weeks

  8. Efficacy Evaluation of T2DM

    fasting insulin concentrations(FINS)

    Measured: From enrollment to the treatment at 24 and 48 weeks

  9. Efficacy Evaluation of T2DM

    fasting C-peptide(FCP)

    Measured: From enrollment to the treatment at 24 and 48 weeks

  10. Efficacy Evaluation of T2DM

    hemoglobin A1c(HbA1c)

    Measured: From enrollment to the treatment at 24 and 48 weeks

  11. Efficacy Evaluation of T2DM

    homeostatic model assessment of insulin resistance(HOMA-IR)

    Measured: From enrollment to the treatment at 24 and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start31 Dec 2024 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06762223
Sponsor's protocol ID
2024NL-195-01
Status last verified
Dec 2024
First submitted
17 Dec 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Henagliflozin 10 mg daily and Metformin 1700 mg daily in people with Metabolic Dysfunction-associated Steatotic Liver Disease and Type 2 Diabetes Mellitus, run by Xiqiao Zhou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tiansu Jiangsu province hospital of traditional chinese medicine (025-17397952085, 728294997@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver stiffness measurements (LSM) of subjects (time frame: From enrollment to the treatment at 24 and 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06762223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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