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CTRI Number  CTRI/2023/08/055982 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 18/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To Evaluate the Safety & Efficacy of Nor- Ursodeoxycholic Acid 1500 mg in patients suffering from Non-alcoholic Fatty Liver Disease. 
Scientific Title of Study   A phase-III, Randomized, Double-blind, placebo controlled, Multi-center, Parallel group, study to Evaluate the Safety & Efficacy of Nor-Ursodeoxycholic Acid 1500 mg in patients suffering from Non-alcoholic Fatty Liver Disease (NAFLD).  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
001/Nor-UDCA/SML/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Vijay Babu 
Designation  Clinical Strategist 
Affiliation  Ardent Clinical Research Services 
Address  Office no.305,309 Level 3 west wing Nyati Unitree
Yerwada Pune
Pune
MAHARASHTRA
411006
India 
Phone  9944293939  
Fax  -  
Email  medicaldirector@ardent-cro.com  
 
Details of Contact Person
Scientific Query  
Name  P Veerendra Kumar 
Designation  Head – Clinical Affairs Division 
Affiliation  Shilpa Medicare Ltd 
Address  Plot No.79, survey no.125, I.D.A., Mallapur,
Uppal Mandal, Medchal- Malkajgiri District,,
Medchal
TELANGANA
500076
India 
Phone  9177033911  
Fax  -  
Email  veerendrap.frd@shilpamedicare.com  
 
Details of Contact Person
Public Query  
Name  Mr Chandu Devanpally  
Designation  Founder & Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Office no.305,309 Level 3 west wing Nyati Unitree
Yerwada Pune
Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax  -  
Email  cdevanpally@ardent-cro.com  
 
Source of Monetary or Material Support  
Shilpa Medicare Ltd.,S – 20 to S – 26 Pharma SEZ TSIIC Green Industrial Park, Polepally Village, Jadcherla Mandal, Mahabubnagar District, Telangana 509 301 
 
Primary Sponsor  
Name  Shilpa Medicare Ltd 
Address  S – 20 to S – 26 Pharma SEZ TSIIC Green Industrial Park, Polepally Village Jadcherla Mandal, Mahabubnagar District Telangana 509 301 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikhileshwar Yandamuri  Aditya Multispecialty Hospital  Department of Gastroenterology, 13-3-52 , 3rd Line ,Gunturivari Thota, Kothapet Beside Peoples Trauma Guntur Guntur Andhra Pradesh -522001
Guntur
ANDHRA PRADESH 		 9848081082
-
itsnikhil.rio@gmail.com 
Dr Patel Rakesh Pravinchandra  Ashirwad Hospital & Research Centre  OPD no 1, Ground Floor, Maratha Section, Near Jijamata Udyan, Ulhas Nagar
Thane
MAHARASHTRA 		 9834613273
-
rppatelge@yahoo.com 
Dr Gaurav Kumar Singh  Brij Medical Centre Pvt. Ltd.  Department of Gastroenterology, 1st Floor, Clinical Research Room94- E, Panki
Kanpur Nagar
UTTAR PRADESH 		 9958486790
-
drgauravkrsingh123@gmail.com 
Dr Kilari Madhu  Government Medical College And Government General Hospital  General medicine 1st Floor, Room no 13, Gastroenterology, Research wing 2nd Floor Beside FM Ward Srikakulam-532001 A.P India
Srikakulam
ANDHRA PRADESH 		 95333124913
-
bioexperts21@gmail.com 
Dr Vinay Kumar  GSVM Medical College  Post Graduate Department of Medicine,Ground Floor
Kanpur Nagar
UTTAR PRADESH 		 8004877113
-
dr.vinaysachan@gmail.com 
Dr S Chalapathi Rao Achanta  KIMS ICON Hospital  CLINICAL RESEARCH DEPARTMENT 1ST FLOOR, OT BLOCK, 121D. No. 32-11-02 Sheelanagar, BHPV Post
Visakhapatnam
ANDHRA PRADESH 		 9908258905
-
STRFWD13@gmail.com 
Dr Venkata Ranga Reddy V  Kurnool Medical College & Govt General Hospital  Gastro Enterology Department, Building OP 26, Budhwarpet Road, Alluri sitaramaraju nagar,
Kurnool
ANDHRA PRADESH 		 9848554555
-
drvallururangareddy@gmail.com 
Dr Bhate Prasad Ashok  Lokmanya Medical Research Center  First Floor Room No-1,314/B Telco Road, Chinchwad
Pune
MAHARASHTRA 		 9920039265
-
prasadbhate07@gmail.com 
Dr Dipanjan Bandyopadhyay  North Bengal Medical College And Hospital  Department of Gastroenterology,D-5 Quarter Sushruta Nagar, Dist, Siliguri,
Darjiling
WEST BENGAL 		 9593944414
-
dipanjanbandyo@gmail.com 
Dr Mandar Doiphode  Sangvi Multispecility Hospital Pvt. Ltd.   OPD no 02, Floor no 4, Room no 404, Krusha Chouk Sangvi Pune 411027
Pune
MAHARASHTRA 		 9850077168
-
dr.mandar.sangvihospital@gmail.com 
Dr Abhinay Raja Rao  St Anns General and Cancer Hospital  Deartment of Gastroenterology, 24-7-7/3, Fatima Nagar Dargha Road, Kazipet
Warangal
TELANGANA 		 9666688749
-
drabhinay.krcwgl@gmail.com 
Dr Mahesh Magulkar  Supe Heart And Diabetes Hospital  OPD no 2, 1 st Floor, room no 02, Opp Adharashram gharpure ghat near Rungtha school Ashok stambha 422002
Nashik
MAHARASHTRA 		 8087537224
-
drmaheshmagulkar22@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Institutional Ethics Committee Kurnool Medical College & GGH  Approved 
Ashirwad Ethics Committee  Approved 
Ethics Committee Brij Medical Centre   Approved 
Ethics Committee GSVM Medical College Kanpur GSVM Medical College Kanpur  Approved 
IEC Aditya Multispecialty Hospital, Guntur  Approved 
Institutional Ethics Committe North Bengal Medical College & Hospital   Approved 
Institutional Ethics Committee Govt. Medical College Govt.General Hospital Balaga Srikakulam  Approved 
Institutional Ethics Committee KIMS Icon Hospital  Approved 
Institutional ethics committee Sai Sneh Hospital and Daignostic Centre Sai Sneh Hospital and Diagnostic Centre  Approved 
Lokmanya Medical Research Centre Ethical Committee  Approved 
St. Anns Institutional Ethics Committee  Approved 
Supe Hospital Ethics Committee Supe Heart Diabetes Hospital and Research centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nor- Ursodeoxycholic Acid   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. 
Comparator Agent  Placebo   Patient will be asked to administer 3 tablets of placebo once daily for 24 weeks of treatment period with approx 240 ml of drinking water after breakfast  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 patients aged between 18 to 65 years both inclusive.
3. Body Mass Index should be below 35kg/m2.
4. 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).
5. Be willing to maintain a stable diet, including no alcohol intake where this applies throughout the entire study.
6. Male and female patients of child-bearing potential must agree to use medically acceptable forms of contraception during the study. 
 
ExclusionCriteria 
Details  1. 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.
2. Female patients who are pregnant or are breast feeding at screening, or who plan to become pregnant during the study.
3. Chronic liver disease other than confirmed NAFLD, including but not limited to the diagnoses/entities.
4. Patient with known condition of chronic Renal disorders, Medical, histologic, and/or imaging history of hepatic cirrhosis.
5. Clinical, endoscopic, imaging and/or laboratory manifestations of portal hypertension, such as spider nevi, splenomegaly, clinically evident ascites formation, nonbleeding gastro-esophageal varices.
6. Patient has known cirrhosis (compensated /decompensated) either based on clinical criteria or liver histology or Imaging techniques.
7. 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).
8. 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).
9. 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.
10. Prior or planned (during the study period) weight reduction surgery (eg,sleeve gastrectomy, Roux-en-Y gastro jejunostomy).
11. Subjects with known history of Type 1 diabetes mellitus.
12. 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.
13. 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.
ii. Uncontrolled hypothyroidism: defined as initiation of thyroid
hormone replacement therapy or dose adjustment of replacementtherapy in the 12 weeks before screening.
14. 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.
15. Uncontrolled systemic hypertension (either treated or untreated) as per PI discretion.
16. 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).
17. 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.
18. 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 patient, and / or interfere with the study’s endpoints. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Nor-Ursodeoxycholic Acid 1500 mg vs. placebo of Nor-
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  
Outcome  TimePoints 
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.
2. Mean Change ALT level at week-6, week18 & week-24.
3. Mean change in AST level at week-6, week-12, week-18 & week24.
4. Mean Change in Lipid Profile from baseline to week-6, week-12, week-18 & week-24.
5. Mean Change in HbA1c from baseline to week 12 & week 24.
6. Proportion of patients with comparative changes in fatty liver stage (using Fibro Scan)
from baseline to week 24 
 
Target Sample Size   Total Sample Size="165"
Sample Size from India="165" 
Final Enrollment numbers achieved (Total)= "165"
Final Enrollment numbers achieved (India)="165" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/08/2023 
Date of Study Completion (India) 12/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
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