| CTRI Number |
CTRI/2025/08/092440 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in people with fatty liver disease to compare the effects of Resmetirom and Saroglitazar, along with AI-based lifestyle support, on liver health and safety. |
|
Scientific Title of Study
|
A Randomized Controlled Trial Assessing the Efficacy and Safety of Resmetirom 80 mg Versus Saroglitazar 4 mg with AI-Enabled Digital Lifestyle Support in MASLD Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mothish waran B |
| Designation |
Clinical Research Associate |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No.7,5th floor, IIISM Department, Sir.C.V.Raman Research Park, SRM nagar, kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
8825580604 |
| Fax |
|
| Email |
drmothishwaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMGRajanandh |
| Designation |
Professor |
| Affiliation |
SRM College of Pharmacy |
| Address |
Room no 1,4th floor, Department of Pharmacy Practice, SRM Medical College Hospital and Research Centre, Kattankulathur.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598464723 |
| Fax |
|
| Email |
mgr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mothishwaran |
| Designation |
Clinical Research Associate |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No.7,5th floor, IIISM Department, Sir.C.V.Raman Research Park, SRM nagar, kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8825580604 |
| Fax |
|
| Email |
drmothishwaran@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mothishwaran |
| Address |
5th floor, IIISM, Sir.C.V.Raman Research park, SRMIST |
| Type of Sponsor |
Other [Self funding for PhD study] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mothishwaran B |
SRM Medical College Hospital and Research Centre |
Room.no b-4/13, 4th floor, B2 block, Department of Medical gastroenterology.
Kancheepuram
TAMIL NADU |
8825580604
drmothishwaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab.Resemetirom 80 mg |
Drug Name: Resmetirom
Dose: 80 mg orally
Frequency: Once daily
Duration: 180 days
Route: Oral administration
Purpose: To reduce liver fat improve liver stiffness and enhance metabolic health in MASLD patients |
| Comparator Agent |
Tab.Saroglitizar 4mg |
Drug Name: Saroglitazar
Dose: 4 mg orally
Frequency: Once daily
Duration: 180 days
Route: Oral administration
Purpose: To serve as active comparator for improving lipid profile reducing liver fat and managing metabolic parameters in MASLD patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult male and female participants aged between more than 18 and less than or equal to 60 years.
2. Participants who are diagnosed with Metabolic dysfunction-associated steatotic liver disease (MASLD) defined as hepatic steatosis in adults (detected either by imaging techniques by biopsy) in addition to one of the following criteria’s namely
A. BMI more than or equal to 25 kg per m2 [23 kg per m2 in Asians] OR Waist circumference (WC) more than 94 cm (Male) 80 cm (Female) OR ethnicity adjusted.
B. Fasting serum glucose more than 5.6 mmol per Litre [100 mg per dL] OR 2-hour post load glucose levels more than or equal to 7.8 mmol per Litre[more than or equal to 140 mg per dL] OR HbA1c more than or equal to 5.7% [39 mmol per Litre) OR type 2 diabetes OR treatment for type 2 diabetes.
C. Blood pressure more than or equal to sysBP130 DysBP 85 mmHg OR specific antihypertensive drug treatment.
D. Plasma triglycerides more than or equal to more than or equal to 1.70 mmol per L [150 mg per dL] OR lipid lowering treatment.
E. Plasma HDL-cholesterol less than or equal to 1.0 mmol per Litre [40 mg per Deci Litre] (M) and more than or equal to 1.3 mmol per Litre [50 mg per dL] (F) OR lipid lowering treatment.
3. Non-invasive FIBROSCAN confirmed hepatic steatosis and stiffness as defined below,
A. Liver Stiffness Measurement (LSM) score of more than or equal to 8 to less than or equal to 12 Kpa as per Vibration Controlled Transient Elastography (VCTE).
B. Any grade of steatosis (S1-S3) as determined by Continuous Attenuation Parameter (CAP). (S1-mild: more than or equal 248 dB per m, S2-moderate:more than or equal 268 dB per m, S3- severe: more than or equal 280 dB per m).
4. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation or remaining celibate by choice) who meets the following criteria:
a. Has not undergone a hysterectomy or bilateral oophorectomy; or
b. Has not attained menopause (Women not menstruating for at least 12 consecutive months).
5. Male participants who are willing to refrain from donating sperm from first admission to the study until 90 days after the study completion.
|
|
| ExclusionCriteria |
| Details |
1. FibroScan LSM more than to 12.5 kPa biopsy-proven advanced fibrosis, or cirrhosis or related complications.
Co-existing chronic liver diseases (e.g., viral hepatitis, autoimmune, DILI, hemochromatosis).
Uncontrolled serious illnesses (e.g., severe anemia, CVD, psychiatric, malignancy), PT-INR more than 1.2.
Muscle Disorders or Myopathies
Bariatric surgery within 1 year, or prior participation in similar studies within 3 months.
6. Any concomitant serious disorders like chronic kidney disease, cardiovascular diseases, pulmonary disease, and use of chemotherapy agents or history of cancer.
7. Gravid women and lactating mother.
8. Heavy smoker, Chronic alcoholic, or drug abuse subjects
9. Known cases of malignancy, HIV infection, AIDS, etc.
10. Participants are not willing to sign the ICF and to attend the treatment schedule regularly.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Liver Stiffness Measurement LSM score measured by FibroScan
Change in Controlled Attenuation Parameter CAP score measured by FibroScan
|
Measured at Baseline and week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in body mass index
Change in waist circumference
Change in HDL cholesterol
Change in triglyceride levels
Change in HbA1C levels
Change in fasting blood glucose levels
Change in systolic blood pressure
Change in diastolic blood pressure
Change in AST levels
Change in ALT levels
Change in ALP levels
Change in total bilirubin levels
Change in quality of life score
Number of adverse events during study period |
Baseline Day 1
Day 30 plus or minus 3 days
Day 60 plus or minus 3 days telephonic
Day 90 plus or minus 3 days
Day 135 plus or minus 3 days telephonic
Day 180 plus or minus 3 days end of study |
|
|
Target Sample Size
|
Total Sample Size="334"
Sample Size from India="334"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2025 |
| 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="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
A Randomized Controlled Trial
Assessing the Efficacy & Safety of Resmetirom 80mg Versus Saroglitazar 4 mg with AI-Enabled
Digital Lifestyle Support in MASLD Patients in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease MASLD. A total of 334 participants will be enrolled and randomly assigned in a 2 to 1 ratio to receive either Resemeritom 80mg or Saroglitizar 4 mg for a duration of 180 days. The study aims to assess changes in liver stiffness and steatosis using FibroScan along with improvements in metabolic health indicators such as BMI lipid profile HbA1C and blood pressure. Quality of life and safety will also be evaluated throughout the study period. The primary outcome is the change in liver stiffness and CAP scores from baseline to day 180. Secondary outcomes include changes in metabolic markers liver function tests and adverse events. Participants will undergo periodic assessments during scheduled visits including baseline day 30 day 60 day 90 day 135 and end of study on day 180. |