To Evaluate the Safety & Efficacy of Nor- Ursodeoxycholic Acid 1500 mg in patients suffering from Non-alcoholic Fatty Liver Disease.

Phase 3

Active, not recruiting

• Conditions: Fatty (change of) liver, not elsewhere classified,

• Registration Number: CTRI/2023/08/055982
• Lead Sponsor: Shilpa Medicare Ltd

Brief Summary

This is a prospective, randomized, double-blind, multi-centric, parallel group,placebo-controlled, Phase III study, evaluating the efficacy and safety of Nor-Ursodeoxycholic Acid 1500mg versus placebo of Nor-Ursodeoxycholic Acid 1500mg in treatment of patients with Non-alcoholic Fatty Liver Disease (NAFLD).The study will be conducted at approximately 6 or more centers in India.The study will involve screening and treatment period.A total of 7 visits will be scheduled to the Investigator site: Visit-1 (Screening Visit-7 days), Visit-2 (Randomization visit or Day 0), Visit-3 (On treatment visit at week-6), Visit-4 (On treatment visit at week-12), visit-5 (On treatment visit at week-18) and Visit-6 (End of treatment at week 24)and visit 7 (week 28 end of study) follow up after 24 weeks treatment.The total duration of study will be approximately 29 weeks, which includes 07 days of screening and 24 weeks of treatment period and 4 weeks (28 week) follow-up after completion of study treatment.all the eligible patients will be randomized to receive one of the treatment arm tests drugs or placebos in 2:1 ratio. All the patients will be instructed to administer 3 tablets of 500mg at a time (total of 1500mg) once daily for 24 weeks of treatment period with 240ml of drinking water after breakfast.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-08
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Must be willing to provide written informed consent to take part in the study and to comply with all the study’s requirements.
• Male and Female patients aged between 18 to 65 years both inclusive.
• Body Mass Index should be below 35kg/m2.
• NAFLD diagnosed by suggestive imaging findings by Fibro scan.
• (A fibrosis score of F2-F3 (As per Metavir 5 scoring system) (>7.5 and <14 kilopascals (kPa)) with abnormal aminotransferase levels ALT with >1.5 and <4 times the upper limit of normal).
• Be willing to maintain a stable diet, including no alcohol intake where this applies throughout the entire study.
• Male and female patients of child-bearing potential must agree to use medically acceptable forms of contraception during the study.

Exclusion Criteria

• Any patient who refuses to provide written informed consent to take part in the study, and/or appears unwilling to comply with study-specific requirements.
• Female patients who are pregnant or are breast feeding at screening, or who plan to become pregnant during the study.
• Chronic liver disease other than confirmed NAFLD, including but not limited to the diagnoses/entities.
• Patient with known condition of chronic Renal disorders, Medical, histologic, and/or imaging history of hepatic cirrhosis.
• Clinical, endoscopic, imaging and/or laboratory manifestations of portal hypertension, such as spider nevi, splenomegaly, clinically evident ascites formation, nonbleeding gastro-esophageal varices.
• Patient has known cirrhosis (compensated /decompensated) either based on clinical criteria or liver histology or Imaging techniques.
• Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness and/or known history of Hepatitis B virus (HBV), defined by presence of hepatitis B surface antigen (HBsAg) and/or known history of Hepatitis C virus (HCV), defined by presence of hepatitis C antibody (HCVAb).
• Chronic use (≥12 months) of any drug known to be associated with development of NAFLD during the 5 years before the anticipated Day 1 visit date (eg, amiodarone, methotrexate, systemic glucocorticoids [unless employed at physiologic replacement doses for management of confirmed adrenal insufficiency], tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement therapy, anabolic steroids [other than testosterone replacement preparations being taken at a physiologic replacement dose for management of confirmed male hypogonadism], sodium valproate, and other hepatotoxins such as minocycline).
• Use of legally prohibited substance or substances within 1 year before the screening visit date in a manner that may jeopardize the patient’s willingness and/or ability to complete study requirements, in the judgment of the investigator.
• Prior or planned (during the study period) weight reduction surgery (eg,sleeve gastrectomy, Roux-en-Y gastro jejunostomy).
• Subjects with known history of Type 1 diabetes mellitus.
• Patients with Type-2 diabetes will be excluded if prescribed current or intended therapy with insulin, glucagon-like peptide-1receptor agonist or DPP-4 inhibitors, any change in oral anti diabetic or statin treatment within the past 12 months before baseline, or with glycated hemoglobin of 9.5% or more.
• Patients with uncontrolled thyroid disorder: i.
• Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism that has either not been treated with either radioactive iodine and/or surgery or that has been treated with radioactive iodine and/or surgery but has required ongoing continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e., methimazole or propylthiouracil) in the 12 weeks before screening.
• Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement therapy or dose adjustment of replacementtherapy in the 12 weeks before screening.
• History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small- bowel resection, or orthotopic liver transplants (OLT) or listed for OLT.
• Uncontrolled systemic hypertension (either treated or untreated) as per PI discretion.
• Patients who demonstrate recent evidence (within 6 months of the anticipated date of the Day 1 visit) of clinically evident and significant atheromatous cardiovascular disease (eg, unstable angina, acute coronary syndrome, myocardial infarction, cerebrovascular accident [stroke],cerebrovascular ischemia, transient ischemic attack, and / or peripheral vascular disease requiring intervention).
• Has participated in an investigational new drug trial during the 30 days before screening visit date, or within 5 half-lives of an investigational agent, whichever is longer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Nor-Ursodeoxycholic Acid 1500 mg vs. placebo of Nor-	1. A proportion of patients achieving ALT normalization from baseline to at week 12. | 2. Proportion of patients with comparative changes in fatty liver stage (using Fibro Scan) | from baseline to week 12.
Ursodeoxycholic Acid for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD).	1. A proportion of patients achieving ALT normalization from baseline to at week 12. | 2. Proportion of patients with comparative changes in fatty liver stage (using Fibro Scan) | from baseline to week 12.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of Nor-Ursodeoxycholic Acid 1500 mg in patients with Non-alcoholic Fatty Liver Disease (NAFLD).	1. Change in NFS score at week 6, week-18 & week 24 from baseline.

Trial Locations

Locations (12)

Aditya Multispecialty Hospital; 🇮🇳 Guntur, ANDHRA PRADESH, India

Ashirwad Hospital & Research Centre; 🇮🇳 Thane, MAHARASHTRA, India

Brij Medical Centre Pvt. Ltd.; 🇮🇳 Nagar, UTTAR PRADESH, India

Government Medical College And Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

KIMS ICON Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Kurnool Medical College & Govt General Hospital; 🇮🇳 Kurnool, ANDHRA PRADESH, India

Lokmanya Medical Research Center; 🇮🇳 Pune, MAHARASHTRA, India

North Bengal Medical College And Hospital; 🇮🇳 Darjiling, WEST BENGAL, India

Sangvi Multispecility Hospital Pvt. Ltd.; 🇮🇳 Pune, MAHARASHTRA, India

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Aditya Multispecialty Hospital

🇮🇳Guntur, ANDHRA PRADESH, India

Dr Nikhileshwar Yandamuri

Principal investigator

9848081082

itsnikhil.rio@gmail.com