Health Condition 1: E888- Other specified metabolic disorders
Conditions
Interventions
Intervention1: Nor-Ursodeoxycholic Acid Nor-UDCA: Patients will be asked to consume 3 tablets of 500 mg once daily
Control Intervention1: Ursodeoxycholic acid: Patients will be asked to consume one ta
Sponsors
Gandhi Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1 Must be willing to provide written informed consent to take part in the study and to comply with all the study requirements 2 Male and Female participants aged above 18 years 3 Diagnosed with Metabolic dysfunction-associated steatotic liver disease MASLD MASLD is defined as the presence of hepatic steatosis confirmed by imaging or biopsy in conjunction with at least one cardiometabolic risk factor and no other discernible cause. EASL guidelines Metabolic risk factors include any one of the following: a Diabetes mellitus- Defined as having Fasting plasma glucose FPG greater than or equal to 126 mgdL or 2 hour plasma glucose greater than or equal to 200 mg dL or Hemoglobin A1c HbA1c greater than or equal to 6.5 percent or Random plasma glucose greater than or equal to 200 mg dL or Diagnosed with T2DM in the past and is on antidiabetic medication b Prediabetes/Impaired glucose tolerance: FPG between 100 and 125 mgdL, or 2-hour plasma glucose during oral glucose tolerance test OGTT between 140 and 199 mgdL, or HbA1c levels between 5.7 percent and 6.4 percent c Obesity or Overweight BMI 25.0 to 29.9 kg m d Dyslipidemia Total cholesterol greater than 200 mg dL or LDL cholesterol greater than 130 mg dL or HDL cholesterol less than 40 mg dL in men less than 50 mg dL in women or Triglycerides greater than 150 mg dL e Hypertension blood pressure of greater than or equal too 140 90 mm Hg or known hypertensive controlled with antihypertensive medications. 4 Liver Stiffness Measurement LSM score of 7.5 and less than 14 kilopascals kPa FibroScan As per Metavir 5 scoring system any participant who pose risk of variability in FibroScan findings-severe Obesity BMI greater than or equal to 35 mg m2 , ascites, need to be excluded 5 Abnormal ALT with greater than 1.5 and less than 4 times the upper limit of normal 6 Hepatic fat fraction greater than or equal to 10 percent on MRI-PDFF 7 NFS score of at least 0.67 at screening 8 FIB-4 score between 1.3 to 2.67 at screening 9 Participants with T2DM HTN can be enrolled if the conditions are at least moderately controlled 10 Be willing to maintain a stable diet including no alcohol intake throughout the entire study 11 Participants who consent to liver biopsy at screening and month 12 should fulfill below 3 criteria additionally a Histological confirmation of steatohepatitis on a diagnostic liver biopsy or biopsy obtained within 3 months prior to Screening or during the Screening Period) b NAS greater than 4 and less than 8 with at least 1 in each component of the NAS steatosis scored 0 to 3 ballooning degeneration scored 0 to 2 and lobular inflammation scored 0 to 3 C Fibrosis stage of greater than 1 and less than 4 according to the NASH CRN fibrosis staging system
Exclusion criteria
Exclusion criteria: 1 Any other causes of chronic liver disease for trial participants including autoimmune hepatitis Wilsons disease hemochromatosis alpha-1 antitrypsin deficiency etc 2 Any serious disease which limits the life expectancy 3 Female participants who are pregnant or are breast feeding at screening 4 Participant has known cirrhosis compensated or decompensated either based on clinical criteria or liver histology or imaging techniques 5 Known history of human immunodeficiency virus HIV infection or acquired immunodeficiency syndrome AIDS related illness 6 Any other condition that in the opinion of the investigator would impede compliance with hinder completion of the study compromise the well-being of the participant and or interfere with the studys endpoints assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of participants achieving : 1 Greater than or equal to 1 stage fibrosis improvement on FibroScan LSM- Metavir scoring 2 Grester than or equal 20 dB m decrease in CAP score on FibroScan 3 normalization of ALT Timepoint: 1 Baseline to month 6 to month 12 2 Baseline to month 6 to month 12 3 Baseline to month 6 to month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent of participants achieving greater than or equal to 1 stage fibrosis improvement on FibroScan LSM- Metavir scoring Percent of participants achieving greater than or equal to 20 dB m decrease in CAP score on FibroScan Proportion of participants with normalization of serum ALT and AST levels Mean change in lipid profile Changes in NFS Changes in FIB-4 score Changes in ELF score 10 Participants from each group Serum proC3 level changes 10 Participants from each group Timepoint: 1 from baseline to month 3 to month 9 2 from baseline to month 3, month 9 3 from baseline to month 3, month 6, month 9 and month 12 4 from baseline to month 3, month 6, month 9 and month 12 5 from baseline to week month 3, month 6, month 9 and month 12 6 from baseline to month 3, month 6, month 9 and month 12 7 from baseline to month 3, month 6, month 9 and month 12 8 from baseline to month 6 and month 12 | — |
Countries
India
Contacts
Public ContactDr Ashish Rajendra Gandhi
Gandhi Hospital
Outcome results
None listed