Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: OERIS 100 mg: OERIS 100 mg Intramascular on Days 1 15 29 of RT plus Placebo of oral Ondansetron BID from Day 1 of RT to 2 days post last RT fraction in Subjects Receiving only RT and Pl
Sponsors
Shilpa medicare limited
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 s requirements. 2 Male and Female participants aged above 18 years 3 Female participants of childbearing potential must use a highly effective contraceptive method e g hormonal contraception intrauterine device intrauterine hormone releasing system bilateral tubal occlusion or true abstinence throughout the study and for 30 days after the last dose of the investigational product 4 Male participants with female partners of childbearing potential must agree to use an acceptable contraceptive method example condom with spermicide partner using a highly effective method or true abstinence throughout the study and for 30 days after the last dose and must refrain from donating sperm during this period 5 Diagnosed with Nonalcoholic Fatty liver disease NAFLD is defined as the presence of hepatic steatosis 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 greater than or equal to 126 mg per dL or 2 hour plasma glucose greater than or equal to 200 mg per dL or Hemoglobin A1c greater than or equal to 6 point 5 percent or Random plasma glucose greater than or equal to 200 mg per dL or diagnosed with T2DM in the past and on antidiabetic medication B Prediabetes Impaired glucose tolerance FPG between 100 and 125 mg per dl or 2 hour plasma glucose during oral glucose tolerance test between 140 and 199 mg per dL or HbA1c levels between 5 point 7 percentage and 6 point four percentage c Obesity Overweight BMI greater than or equal to 23 point 0 kg per meter square d Dyslipidemia Total cholesterol greater than 200 mg per dL or LDL cholesterol greater than 130 mg per dL or HDL cholesterol less than 40 mg per dL in men less than 50 mg per dL in women or Triglycerides greater than 150 mg per dL e Hypertension blood pressure of greater than or equal to 140 per 90 mm Hg or known hypertensive on antihypertensive medications 6 Liver Stiffness Measurement score of 7 point 5 and less than 14 kilopascals on FibroScan 7 Abnormal ALT with greater than 1 point 5 and less than 4 times the upper limit of normal 8 NFS score of at least 0 point 67 at screening 9. FIB 4 score between 1 point 3 to 2 point 67 at screening 10 Participants with T2DM HTN can be enrolled if the conditions are at least moderately controlled 11 Be willing to maintain a stable diet, including no alcohol intake
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 is limiting the life expectancy 3 Mental instability or incompetence such that the validity of the informed consent or ability to be compliant with the study is uncertain 4 Female participants who are pregnant or are breast feeding at screening 5 Participant has known cirrhosis compensated decompensated either based on clinical criteria or liver histology or imaging techniques 6 Known history of human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness 7 Any other condition tha 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment emergent adverse events (TEAEs) and serious adverse eventsTimepoint: From Baseline to end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Percent of participants achieving all three of the following greater than or equal to 1 stage fibrosis improvement on FibroScan LSM Metavir scoring Greater than or equal to 1 grade reduction in liver fat steatosis Normalization of ALT and AST 2 Proportion of participants with comparative changes in NAFLD fibrosis stage 3 Proportion of participants with change in steatosis 4 Proportion of participants with normalisation of serum ALT and AST levels 5 Mean change in lipid profile 6 Changes in NFS 7 Changes in FIB 4 score Timepoint: 1 From baseline week 24 to EOT 2 From baseline to week 12 week 24 week 36 and week 52 3 From baseline to week 12 week 24 week 36 and week 52 4 From baseline to week 12 week 24 week 36 and week 52 5 From baseline to week 12 week 24 week 36 and week 52 6 From baseline to week 12 week 24 week 36 and week 52 7 From baseline to week 12 week 24 week 36 and week 52 | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
Shilpa Medicare Limited
Outcome results
None listed