| CTRI Number |
CTRI/2025/07/090817 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| 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 Efficacy and Safety of Resmetirom Tablets in Subjects with fat accumulated in liver not due to alcohol consumption and with Moderate to Advanced Liver Fibrosis. |
|
Scientific Title of Study
|
A Prospective, Randomized, Multicentric, Double-Blind, Double-Dummy, Placebo controlled, Parallel Group, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Resmetirom Tablets (Strengths 60mg, 80mg and 100mg) in Subjects with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis (Consistent with Stages F2 to F3 Fibrosis) |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ECTS/25/004,Ver. 01,Date:19 MAY 2025,Amend 001,24 JUL 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milan Satia |
| Designation |
Managing Director |
| Affiliation |
Ethicare Clinical Trial Services (OPC) Pvt. Ltd. |
| Address |
Block F-1101 to 1110, Prahlad Nagar Trade Center (PNTC), Radio Mirchi Road, Nr. Vastrapur
Railway Crossing
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milan Satia |
| Designation |
Managing Director |
| Affiliation |
Ethicare Clinical Trial Services (OPC) Pvt. Ltd. |
| Address |
Block F-1101 to 1110, Prahlad Nagar Trade Center (PNTC), Radio Mirchi Road, Nr. Vastrapur
Railway Crossing
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Muneeb Ahsan |
| Designation |
DGM - Clinical Research and Biopharmaceutics |
| Affiliation |
Mankind Research Center |
| Address |
Sector-4/II, IMT Manesar, Gurgaon
Gurgaon
HARYANA
122050
India |
| Phone |
9818152572 |
| Fax |
|
| Email |
muneeb.ahsan@mankindpharma.com |
|
|
Source of Monetary or Material Support
|
| Mankind Pharma Limited
208, Okhla Industrial Estate, Phase – 3, New Delhi-110020 |
|
|
Primary Sponsor
|
| Name |
Mankind Pharma Limited |
| Address |
208, Okhla Industrial Estate, Phase – 3, New Delhi-110020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 22 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeraj Singla |
Advanced Gastroenterology Institute |
Ludhiana Road Vth Floor Orison Hospital, Barewal Rd,
Ludhiana
PUNJAB |
7888619216
Dr.neerajsingla@gmail.com |
| Dr Shachish Piyush |
Alfa Gastro and Liver care |
605,6th floor Consulting room 01
Ahmadabad
GUJARAT |
9428738397
shachishdoctorct@gmail.com |
| Dr Shalimar |
All India Institute of Medical Sciences (AIIMS) |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
New Delhi
DELHI |
9968405815
drshalimar@yahoo.com |
| Dr Vipul Prajapati |
GCS Medical College, Hospital & Research Centre |
2nd Floor OPD 05, Department of Gastroenterologist
Ahmadabad
GUJARAT |
9909912551
prajapativipul1983@gmail.com |
| Dr Vaibhav Ganjewar |
GI-One Hospital |
V867+PP4 Siddharth Arcade, Railway Station Rd, Vedant Nagar, Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA |
7720035616
vaibhav.gastro@gmail.com |
| Dr Pintukumar Bhakhar |
Global hospital |
4th floor Global Point, Nr. Navjivan restaurant, Sarthana Jakat Naka
Surat
GUJARAT |
9979587580
globalhospitalcr@gmail.com |
| Dr Ankit Makadia |
Gokul Hospital |
3rd Floor OPD 04, Department of Gastroenterologist
Rajkot
GUJARAT |
8796470955
amakadia4@gmail.com |
| Dr Keyur Brahme |
Government Medical College and Sir Sayajirao General Hospital (SSGH) |
OPD-18,First Floor, Department of Medicine
Vadodara
GUJARAT |
9727729105
Keyurbrahme@gmail.com |
| DrVinay Kumar |
GSVM hospital |
Ground Floor OPD 02, Department of Gastroenterologist
Kanpur Nagar
UTTAR PRADESH |
8004877113
dr.vijaysachan@gmail.com |
| Dr Manoj kumar |
Jawhar lal nehru medical college |
Ground Floor OPD 18, Department of Gastroenterologist
Ajmer
RAJASTHAN |
8118877284
kkcrc90@gmail.com |
| Dr Krunal patel |
Jivan gastro & gynaec hospital |
Block -C ground floor OPD 4 , Department of Gastroenterologist
Ahmadabad
GUJARAT |
9909477693
pkrunal11@yahoo.in |
| Dr Dharmendra |
KR Hospital, Mysore Medical College and Research Institute |
2nd Floor OPD 02, Department of Gastroenterologist
Mysore
KARNATAKA |
9844400382
Drdharmu21@gmail.com |
| Dr Sailesh Dube |
Mahavir hospital |
1st floor, OPD 03, Department of Medicine
Ahmadabad
GUJARAT |
9986327078
contact@bhandarihospital.net |
| Dr Shyam Sunder |
Mangalam Plus Medicity Hospital |
Ground floor OPD 02, Department of Gastroenterologist
Jaipur
RAJASTHAN |
7959115555
mmedicityresearch@gmail.com |
| Dr Subhik Ghosh |
Medical College and Hospital Kolkata |
3rd floor OPD 02, Department of Gastroenterology
Kolkata
WEST BENGAL |
8017585988
souvikpgi@gmail.com |
| Dr Kamleshkumar Magnani |
Nand Hospital |
1st Floor OPD 03, Department of Gastroenterologist
Vadodara
GUJARAT |
9625196109
drkamleshmagnaiicr@gmail.com |
| Dr Nitin Shankar Behl |
Neurociti Hospital and Diagnostics Centre |
B-XX/2034, near HOTEL ONN, Gobind Nagar
Ludhiana
PUNJAB |
8427000080
drnitinbehl@gmail.com |
| Dr Pinaki Roy |
Nil Ratan circar medical college & hospital |
2nd Floor OPD 02, Department of Gastroenterologist
Kolkata
WEST BENGAL |
9474891727
drpinaki1979@gmail.com |
| Dr Vatsal Mehta |
OHM Hospital |
2nd Floor OPD 03, Department of Gastroenterologist
Ahmadabad
GUJARAT |
8424076444
vatsalmehta6387@gmail.com |
| Dr Anirban De |
Panacea Hospital & Diabetes Care Organization |
B 36/44 B-4 Kabir Nagar Road, Durgakund Rd, near Sanjay Siksha Niketan, Kabir Nagar
Varanasi
UTTAR PRADESH |
7548835016
anirbande14@gmail.com |
| Dr Rajesh |
Rajalkshmi Hospital & Research Center |
Ground floor OPD 02, Department of Gastroenterologist
Bangalore
KARNATAKA |
9553252525
pendalimarai.rajesh@gmail.com |
| Dr Make Naveen Chand |
Visakha lnstitute of Medical Sciences (VIMS) |
Ground floor OPD 01, Department of Gastroenterologist
Visakhapatnam
ANDHRA PRADESH |
9885837772
drmnaveenchandresearch@gmai l.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 22 |
| Name of Committee |
Approval Status |
| EC GSVM Medical College |
Approved |
| Ethics Committee, OHM Hospital |
Approved |
| Global Ethics committe |
Approved |
| IEC, GCS Medical College, Hospital and Research Centre |
Approved |
| IEC, Mahavir hospital |
Approved |
| IEC, Mahavir hospital (Alfa Gastro and Liver care) |
Approved |
| IEC, Mahavir hospital (Jivan gastro & gynaec hospital) |
Approved |
| IEC,Anand Multispeciality Hospital |
Approved |
| IEC,Human Research Medical College & Hospital |
Submittted/Under Review |
| IEC,Jawhar lal nehru medical college |
Approved |
| IEC,Mangalam Medicity Hospital |
Approved |
| IEC,NRS Medical College |
Approved |
| IEC,Rajalkshmi Hospital & Research |
Approved |
| IEC,Visakha lnstitute of Medical Sciences |
Approved |
| IEC-Gokul Lifecare pvt.ltd |
Approved |
| IEC-MMC and RI and Associated Hospital |
Submittted/Under Review |
| Institutional Ethics Committee All India Institute of Medical Science |
Approved |
| Institutional Ethics Committee for Human Research (IECHR) Medical College Baroda |
Approved |
| Institutional review board of Sidhu Educational research Institute & Hospital (Gastro, Liver, and Pancreas Clinic) |
Approved |
| Institutional review board of Sidhu Educational research Institute & Hospital (Neeyati Gastro and Skin CIinic) |
Approved |
| Krishna Ethics Committee |
Approved |
| MGM Ethics Committee for Research on Human Subject |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
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 |
| Comparator Agent |
Placebo |
Take tablet once a day orally, swallowed with water around same time every day for 52 weeks. |
| Intervention |
Resmetirom Tablets 100 mg |
Take tablet once a day orally, swallowed with
water around same time every day for 52 weeks. |
| Intervention |
Resmetirom Tablets 80 mg |
Take tablet once a day orally, swallowed with water around same time every day for 52 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosis of NASH.
2) Historical liver biopsy.
3) Biopsy-proven NASH.
4) Subjects should not have received any medication
5) Documented diagnosis of moderate to advanced liver fibrosis.
6) Subjects receiving antidiabetic, antihypertensive, lipid modifying medication(s) as background therapy.
7) Subject is willing to provide written informed consent document and have ability and willingness to adhere to the protocol.
8) Subjects willing to maintain consistent lifestyle habits.
9) Women of childbearing potential must have a negative urine pregnancy test and agree to use highly effective methods of contraception to prevent pregnancy. |
|
| ExclusionCriteria |
| Details |
1) History of cirrhosis or liver-related complications.
2) History of significant alcohol consumption.
3) Subjects with type 1 & 2 diabetes mellitus.
4) Any current or prior history of decompensated liver disease.
5) History or presence of concomitant liver diseases other than NASH at screening.
6) Subjects receiving prohibited drugs.
7) Thyroid diseases.
8) History of weight reduction surgery or planned.
9) History of major or minor surgery or invasive procedure.
10) Subjects with any of the abnormal laboratory values at screening.
11) Subjects with known cases of infection with hepatitis B, hepatitis C or HIV.
12) Known allergy, sensitivity or intolerance to the study drug.
13) Subjects had been participated in any clinical trials for NASH or had been participated in any other investigational drug clinical trial.
14) Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and neither surgically sterilized nor willing to use reliable contraceptive methods.
15) Male subjects who are engaging in sexual activity with female partner of child-bearing potential and not willing to use reliable contraceptive methods throughout the study duration.
16) Any clinically significant condition that in the investigator’s opinion may hinder the subject’s participation in the study or can interfere with the interpretation of the study results.
17) Subjects with suspected inability or unwillingness to comply with the study procedures. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean Percentage change in liver fat content. |
Baseline to week 52 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with resolution of NASH with no worsening of fibrosis as assessed by Biopsy |
EOT/EOS (week 52) |
| Proportion of subjects with at least a 1-point improvement in fibrosis stage with no worsening of steatohepatitis |
EOT/EOS (week 52) |
| Mean % change in liver fat content |
Baseline to Week 24 |
| Mean absolute change in liver fat. |
Baseline to EOT/EOS (week 52). |
| Mean change in liver stiffness and controlled attenuation parameter (CAP) |
Baseline to EOT/EOS (week 52)
|
Mean change in alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase
(GGT) |
Baseline to EOT/EOS (week 52) |
| Changes in lipid profile [total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, high density lipoproteins (HDL) cholesterol, triglycerides (TG)] |
Baseline to EOT/EOS (week 52) |
| Mean changes in thyroid function tests |
Baseline to EOT/EOS (week 52) |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 study will be conducted to evaluate the Efficacy and Safety of Resmetirom Tablets in Subjects with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) . Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study.Subjects will be randomized into one of the three treatment arms either test arm-1, test arm-2 or placebo arm . They will either receive test product Arm 1: Resmetirom Tablets 80 mg or test product Arm 2: Resmetirom Tablets 100 mg or arm 3: Placebo. Primary end point will be mean percentage change in liver fat content . Secondary end point will be proportion of subjects with resolution of NASH with no worsening of fibrosis and proportion of subjects with at least a 1-point improvement in fibrosis stage with no worsening of steatohepatitis etc. |