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Clinical Trial Details

Trial ID: L3658
Source ID: NCT05872269
Associated Drug: Saroglitazar
Title: A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: NAFLD|Obesity|Type 2 Diabetes|Dyslipidemias|Metabolic Syndrome
Interventions: DRUG: Saroglitazar
Outcome Measures: Primary: Change in liver stiffness, liver stiffness measurement performed by transient elastography, Baseline to Week 52|Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs), Baseline to Week 52 | Secondary: Change in TG, HDL-C, LDL-C and non HDL-C levels, Baseline to Week 24 and Week 52|Change in serum ALT value, Baseline to Week 24 and Week 52|Change in serum AST value, Baseline to Week 24 and Week 52|Change in serum ALP value, Baseline to Week 24 and Week 52|Change in body weight, Baseline to Week 24 and Week 52|Change in BMI, Baseline to Week 24 and Week 52
Sponsor/Collaborators: Sponsor: Zydus Lifesciences Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 1500
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-20
Completion Date: 2025-06-10
Results First Posted:
Last Update Posted: 2024-02-07
Locations: 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, Rupnagar, India|BAPS Pramukh Swami Hospital, Sūrat, India
URL: https://clinicaltrials.gov/show/NCT05872269