Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05872269
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588741', 'term': 'saroglitazar'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-03', 'studyFirstSubmitDate': '2023-05-13', 'studyFirstSubmitQcDate': '2023-05-13', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in liver stiffness', 'timeFrame': 'Baseline to Week 52', 'description': 'liver stiffness measurement performed by transient elastography'}, {'measure': 'Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)', 'timeFrame': 'Baseline to Week 52'}], 'secondaryOutcomes': [{'measure': 'Change in TG, HDL-C, LDL-C and non HDL-C levels', 'timeFrame': 'Baseline to Week 24 and Week 52'}, {'measure': 'Change in serum ALT value', 'timeFrame': 'Baseline to Week 24 and Week 52'}, {'measure': 'Change in serum AST value', 'timeFrame': 'Baseline to Week 24 and Week 52'}, {'measure': 'Change in serum ALP value', 'timeFrame': 'Baseline to Week 24 and Week 52'}, {'measure': 'Change in body weight', 'timeFrame': 'Baseline to Week 24 and Week 52'}, {'measure': 'Change in BMI', 'timeFrame': 'Baseline to Week 24 and Week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Real World Evidence Study'], 'conditions': ['NAFLD', 'Obesity', 'Type 2 Diabetes', 'Dyslipidemias', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).', 'detailedDescription': 'The study is being planned to evaluate long term safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD).\n\nTotal 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients aged ≥18 years\n2. Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time)\n3. Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol\n\n .\n4. 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:\n\n 1. Liver stiffness through transient elastography, an LSM ≥8 kPa OR\n 2. Serum ALT ≥45 U/L\n\nExclusion Criteria:\n\n1. Consumption of alcohol for at least 90 consecutive days in last one year: \\>2 units of alcohol per day (\\>14 units per week) for males and \\>1 unit of alcohol per day (\\>7 units per week) for females. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30 mL of spirits/hard liquor\n2. History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.\n3. Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.\n4. Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.\n5. 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.\n6. Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.\n7. Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.\n8. Pregnant or breast feeding females'}, 'identificationModule': {'nctId': 'NCT05872269', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zydus Lifesciences Limited'}, 'officialTitle': 'A Phase 4, Non-randomized, Multicentre, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of Saroglitazar 4 mg in Patients With Non Alcoholic Fatty Liver Disease (NAFLD) With Comorbidities (Either Obesity, Type 2 Diabetes Mellitus, Dyslipidemia or Metabolic Syndrome)', 'orgStudyIdInfo': {'id': 'SARO.21.003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saroglitazar 4 mg tablets', 'description': 'Oral (once daily ) during 364 days/52 weeks of treatment period.', 'interventionNames': ['Drug: Saroglitazar']}], 'interventions': [{'name': 'Saroglitazar', 'type': 'DRUG', 'description': '4 Mg Oral Tablet', 'armGroupLabels': ['Saroglitazar 4 mg tablets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ahmedabad', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr. Ravindra Gaadhe', 'role': 'CONTACT'}], 'facility': 'Gastroplus Digestive Disease Centre', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Ahmedabad', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Chirag Shah', 'role': 'CONTACT'}], 'facility': 'Mission GastroHospital', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Gurgaon', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Pawan Raval', 'role': 'CONTACT'}], 'facility': 'Artemis Hospital', 'geoPoint': {'lat': 25.49781, 'lon': 82.15916}}, {'city': 'Gurgaon', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Neeraj Saraf', 'role': 'CONTACT'}], 'facility': 'Medanta- TheMedicity', 'geoPoint': {'lat': 25.49781, 'lon': 82.15916}}, {'city': 'Hyderabad', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr P Kranthi Kumar', 'role': 'CONTACT'}], 'facility': 'Malla ReddyNarayanaMultispecialtyHospital', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Hyderabad', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr B Ramesh Kumar', 'role': 'CONTACT'}], 'facility': 'Osmania GeneralHospital', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Hyderabad', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr B Ravishankar', 'role': 'CONTACT'}], 'facility': 'Yashoda Hospitals', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Indore', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Sandeep Julka', 'role': 'CONTACT'}], 'facility': 'CARE CHL -Hospitals (Unit ofConvenient HospitalLtd.', 'geoPoint': {'lat': 22.71792, 'lon': 75.8333}}, {'city': 'Jaipur', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Mukesh Kalla', 'role': 'CONTACT'}], 'facility': 'S R Kalla MemorialGastro and GenralHospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Khorda', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Manas Kumar Panigrahi', 'role': 'CONTACT'}], 'facility': 'AIIMS', 'geoPoint': {'lat': 21.46439, 'lon': 74.11059}}, {'city': 'Lucknow', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Abhai Verma', 'role': 'CONTACT'}], 'facility': 'Medanta Hospital', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'city': 'Ludhiāna', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Omesh Goyal', 'role': 'CONTACT'}], 'facility': 'Dayanand MedicalCollege & Hospital', 'geoPoint': {'lat': 28.49596, 'lon': 77.85739}}, {'city': 'Ludhiāna', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Nitin Shanker Behl', 'role': 'CONTACT'}], 'facility': 'Neurociti Hospital', 'geoPoint': {'lat': 28.49596, 'lon': 77.85739}}, {'city': 'Mumbai', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Shubham Jain', 'role': 'CONTACT'}], 'facility': 'TNMC & BYL NairCh. Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Nashik', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Soham Doshi', 'role': 'CONTACT'}], 'facility': 'Shree Siddhivinayak Maternity & Nursing Home', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'city': 'New Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Naresh Bansal', 'role': 'CONTACT'}], 'facility': 'Sir GangaramHospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'Panchkula', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Daksh Khurana', 'role': 'CONTACT'}], 'facility': 'Alchemist Hospital', 'geoPoint': {'lat': 30.69461, 'lon': 76.8504}}, {'city': 'Rūpnagar', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Kiran Pal Singh', 'role': 'CONTACT'}], 'facility': 'Fortis Hospital', 'geoPoint': {'lat': 27.50774, 'lon': 82.20899}}, {'city': 'Sūrat', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr. Parshottam Koradia', 'role': 'CONTACT'}], 'facility': 'BAPS Pramukh Swami Hospital', 'geoPoint': {'lat': 31.39868, 'lon': 77.14969}}], 'centralContacts': [{'name': 'Dr Kevin Kansagra, MD', 'role': 'CONTACT', 'email': 'kevinkumarkansagra@zyduslife.com', 'phone': '02717-665555', 'phoneExt': '451'}], 'overallOfficials': [{'name': 'Dr. Deven Parmar, MD,FCP', 'role': 'STUDY_CHAIR', 'affiliation': 'Zydus Therapeutics Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zydus Lifesciences Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}