To study Effectiveness and Side effects of Resmetirom for the Treatment of Patients having Fatty liver with Liver Fibrosis
Scientific Title of Study
A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Resmetirom for the Treatment of Patients with Non-Alcoholic Steatohepatitis with Moderate to Advanced Liver Fibrosis
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/25/013 Version No. 1.0; Dated 09/JUN/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Associate Vice President, Head - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House,Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai-400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
919819767704
Fax
022 43244323
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Dipesh Sonawane
Designation
Deputy General Manager - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House,Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai-400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
022 43244323
Email
Dipesh.Sonawane@sunpharma.com
Details of Contact Person Public Query
Name
Dr Rajiv Yadav
Designation
Senior Manager-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House,Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai-400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
9819435169
Fax
02243244343
Email
Rajiv.Yadav1@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited (SPLL)
Primary Sponsor
Name
Sun Pharma Laboratories Limited (SPLL)
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Department of Gastroenterology 603, Golden Icon, Opp. Medilink Hospital, Between Shivranjani-Shyamal Cross Road, 132 Feet Ring Road, Satellite, Ahmedabad - 380015, Gujarat. Ahmadabad GUJARAT
9819277795
drdhavalgupta@gmail.com
Dr Misra Sri Prakash
MLN Medical College
George Town, Prayagraj
211002 Uttar Pradesh India Allahabad UTTAR PRADESH
7376141732
drspmisra@gmail.com
Dr Kolhe Manoj Chandrakant
Ojas Multispeciality Hospital
Ground Floor, OPD No. 01, Bhondave Chowk
D.Y. Patil College Road, Ravet, Pune – 412101.
Pune MAHARASHTRA
8089123645
manojck008@gmail.com
Dr B Ramesh Kumar
Osmania General Hospital
Department of Gastroenterology, NPR Block 1st floor, Liver care unit, Afzalgunj, Hyderabad, Telangana Hyderabad TELANGANA
9949043290
bhashyakarla_rk@yahoo.co.in
Dr Seth Vishalkumar Ratnakar
Pulse Multispeciality Hospital
Survey No. 51/7/B/1, First Floor,
Vishwa Arcade, Opp. Deccan Pavilion Hotel,
Mumbai–Bangalore Highway, Narhe,
Pune, Maharashtra – 411041
Pune MAHARASHTRA
9970126406
drvishalsethpulse@gmail.com
Dr Parth Shah
Ratan Multispecialty Hospital
Surgen Triangle,Opp Govindwadi,
lsanpur,Ahmedabad-382443, Gujarat, India.
Ahmadabad GUJARAT
7922683041
netajipolyclinic.iec@gmail.com
Dr Akash Shukla
Reliance Foundation Hospital Trust
Room no. 212, 2nd floor heritage building, Prarthana Samaj, Raja Rammohan Roy Rd, Girgaon, Mumbai, Maharashtra, India – 400004.
Mumbai (Suburban) MAHARASHTRA
9137009394
drakashshukla@yahoo.com
Dr Bhate Prasad Ashok
Sparsh Specialty Hospital
Rahatani,Pimpri-Chinchwad Maharashtra 411017 Pune MAHARASHTRA
9970849872
dr.roshan.gmc@gmail.com
Dr Desai Nutan Devendra
Upasani Super Speciality Hospital
Plot No 1109/A, Devi Dayal Cross Road, Behind Fire
Station, P & T Staff Colony, Mulund West-400080 Mumbai MAHARASHTRA
APPLE SARASWATI MUL TISPECIALITY HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE ASMHIEC
Approved
Care Multispeciality Hospital
Approved
Central Independent Ethics Committee- CIEC
Approved
Ethics Committee of Pulse Multispecialty Hospital
Approved
Ethics Committee, GSVM Medical College
Submittted/Under Review
Gastroplus Ethics Committee
Approved
Gastroplus Ethics Committee
Approved
IEC of Sir H N Reliance Foundation Hospital and RC
Submittted/Under Review
Institutional Ethics Committee for Human Research
Submittted/Under Review
Institutional Ethics Committee, GMCH
Submittted/Under Review
Institutional Ethics Committee, JSS Medical College
Approved
Institutional Ethics Committee, MLN Medical College
Approved
Institutional Ethics Committee, Osmania Medical College
Submittted/Under Review
LEELAVATI ETHICS COMMITTEE (LEC)
Approved
Medanta Institutional Ethics Committee
Submittted/Under Review
Medilink Ethics Committee, Medilink Hospital Research Centre
Submittted/Under Review
MGM ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECT
Approved
NETAJI POLYCLINIC INSTITUTIONAL ETHICS COMMITTEE
Approved
Ojas Multispeciality Hospital Ethics Committee
Approved
Suraksha – Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: K740||Hepatic fibrosis,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Placebo of Resmetirom Tablets
Placebo of Resmetirom Tablets 60 mg, 80 mg, 100 mg, Once Daily for 52 Weeks
Intervention
Resmetirom Tablet
Resmetirom Tablets 60 mg, 80 mg or 100 mg, Once Daily for 52 Weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients of either gender with age between 18 to 65 years (both inclusive) and willing to provide written informed consent.
2. Who do not have any history of significant alcohol consumption
3. Have at least 3 metabolic risk factors
4. Biopsy-proven Diagnosis of NASH based on a liver biopsy with fibrosis stage 2, or 3 on liver biopsy and NAS of greater than or equal to 4
5. Women of childbearing potential must have a negative urine pregnancy test at Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study
6. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners should be practicing highly effective contraception throughout the study period.
ExclusionCriteria
Details
1) History of significant alcohol consumption
2) Regular use of drugs historically associated with NAFLD
3) Thyroid diseases
4) History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
5) Weight gain or loss of greater than or equal to 5% total body weight within 12 weeks prior to randomization.
6) Type 2 diabetes patients with HbA1c greater than or equal to 9.0%.
7) Glucagon-like peptide 1 [GLP-1] agonist therapy.
8) Use of high dose vitamin E
9) Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
10) Diagnosis of hepatocellular carcinoma (HCC).
11) Hepatic decompensation
12) Patients with other chronic liver diseases
13) Patients having an active autoimmune disease,
14) Inability to safely obtain a liver biopsy.
15) Hypersensitivity to Resmetirom or to any of the excipients in study medications.
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Proportion of patients achieving NASH resolution with no worsening of fibrosis
[Timeframe: Week 52]
week 52
Secondary Outcome
Outcome
TimePoints
Efficacy
Proportion of MRI-PDFF Responders (patients achieving greater than or equal to 30% relative reduction in hepatic
fat content)
[Timeframe: Week 24, 52]
Additional NAS and Fibrosis endpoints on Liver biopsy
Change from baseline in Serum ALT, AST, GGT and ALP
[Timeframe: Baseline, Weeks 24,52]
Change from baseline in Serum total cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL cholesterol and triglycerides
[Timeframe: Baseline, Weeks 24, 52]
Change from baseline in FibroScan LSM score
[Timeframe: Baseline, Weeks 24 and 52]
Change from baseline in FibroScan CAP score
[Timeframe: Baseline, Weeks 24 and 52]
Proportion of patients with a greater than or equal to30% reduction in FibroScan LSM score
[Timeframe: Weeks 24 and 52]
Change from baseline in SF-36 score
[Timeframe: Baseline, Weeks 24 and 52]
Safety:
Number and proportion of patients with treatment emergent adverse events (TEAEs) and Serious Adverse Events (SAEs)
[Timeframe: Throughout study duration]
Target Sample Size
Total Sample Size="206" Sample Size from India="206" 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)
15/10/2025
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="1" Days="17"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
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 will be a phase III, Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety of Resmetirom for the Treatment of Patients with Non-Alcoholic Steatohepatitis with Moderate to Advanced Liver Fibrosis. Approximately 206 patients (103 patients in each arm) will be enrolled in the study from various parts of India. The study will be initiated only after the receipt of Regulatory and Ethics committee (EC) approvals. The patients, investigators who will assess the patients for efficacy and safety, and the Pathologists who will assess the Liver Biopsy Specimens will be blinded to treatment allocation. After signing the informed consent document (ICD), patients will be screened by undergoing various assessments as mentioned in Schedule of Assessments,
Total screening period is up to 5 weeks (Step 1- Up to 1 week, Step 2 Up to 4 weeks). Patients will be provided the screening diary at Step 1 Screening visit to record details of any adverse events or any medications taken. Patients will be required to bring completed visit diary at Step 2 Screening visit. If patient is eligible for Step 2, the screening diary will be returned to the patients and will be retrieved at the Baseline/Randomization Visit.
After confirming eligibility at Visit 3 (Baseline / randomization visit), The randomization will be stratified by type-2 diabetes status (presence/absence) and fibrosis stage (2, or 3) on liver biopsy at screening visit. Patients will receive either Resmetirom 60 mg, 80 mg or 100 mg Tablets, once daily for 52 Weeks as a test product or Placebo of Resmetirom 60 mg, 80 mg or 100 mg Tablets, once daily for 52 Weeks as a comparator product. Test product will be administered once daily (preferably at the evening time), with or without meals. Patients will be advised to take the medication preferably at same time
At each visit, from Visit 3 to Visit 12, participants will be given diaries to record details of study medication administration (to be recorded only till Visit 11), AEs, concomitant medications, and diet/exercise control. Participants will be required to bring completed visit diaries at each visit, Liver biopsies will be performed for all eligible patients at Screening Visit (Step 2) and at EOT (Week 52) visit.