A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities
NCT ID: NCT05872269
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1500 participants
INTERVENTIONAL
2023-07-20
2025-06-10
Brief Summary
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Detailed Description
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Total 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Saroglitazar 4 mg tablets
Oral (once daily ) during 364 days/52 weeks of treatment period.
Saroglitazar
4 Mg Oral Tablet
Interventions
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Saroglitazar
4 Mg Oral Tablet
Eligibility Criteria
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Inclusion Criteria
2. Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time)
3. Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol
.
4. Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria. NAFLD is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease. In addition, patients must have one of the following criteria to indicate ongoing NAFLD at screening:
1. Liver stiffness through transient elastography, an LSM ≥8 kPa OR
2. Serum ALT ≥45 U/L
Exclusion Criteria
2. History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
3. Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
4. Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
5. History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study.
6. Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.
7. Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.
8. Pregnant or breast feeding females
18 Years
80 Years
ALL
No
Sponsors
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Zydus Lifesciences Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Deven Parmar, MD,FCP
Role: STUDY_CHAIR
Zydus Therapeutics Inc.
Locations
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Gastroplus Digestive Disease Centre
Ahmedabad, , India
Mission GastroHospital
Ahmedabad, , India
Artemis Hospital
Gurgaon, , India
Medanta- TheMedicity
Gurgaon, , India
Malla ReddyNarayanaMultispecialtyHospital
Hyderabad, , India
Osmania GeneralHospital
Hyderabad, , India
Yashoda Hospitals
Hyderabad, , India
CARE CHL -Hospitals (Unit ofConvenient HospitalLtd.
Indore, , India
S R Kalla MemorialGastro and GenralHospital
Jaipur, , India
AIIMS
Khorda, , India
Medanta Hospital
Lucknow, , India
Dayanand MedicalCollege & Hospital
Ludhiāna, , India
Neurociti Hospital
Ludhiāna, , India
TNMC & BYL NairCh. Hospital
Mumbai, , India
Shree Siddhivinayak Maternity & Nursing Home
Nashik, , India
Sir GangaramHospital
New Delhi, , India
Alchemist Hospital
Panchkula, , India
Fortis Hospital
Rūpnagar, , India
BAPS Pramukh Swami Hospital
Sūrat, , India
Countries
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Central Contacts
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Facility Contacts
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Dr. Ravindra Gaadhe
Role: primary
Dr Chirag Shah
Role: primary
Dr Pawan Raval
Role: primary
Dr Neeraj Saraf
Role: primary
Dr P Kranthi Kumar
Role: primary
Dr B Ramesh Kumar
Role: primary
Dr B Ravishankar
Role: primary
Dr Sandeep Julka
Role: primary
Dr Mukesh Kalla
Role: primary
Dr Manas Kumar Panigrahi
Role: primary
Dr Abhai Verma
Role: primary
Dr Omesh Goyal
Role: primary
Dr Nitin Shanker Behl
Role: primary
Dr Shubham Jain
Role: primary
Dr Soham Doshi
Role: primary
Dr Naresh Bansal
Role: primary
Dr Daksh Khurana
Role: primary
Dr Kiran Pal Singh
Role: primary
Dr. Parshottam Koradia
Role: primary
Other Identifiers
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SARO.21.003
Identifier Type: -
Identifier Source: org_study_id
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