A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities
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)
1 other identifier
interventional
1,500
1 country
19
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2023
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2023
CompletedFirst Posted
Study publicly available on registry
May 24, 2023
CompletedStudy Start
First participant enrolled
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2025
CompletedFebruary 7, 2024
February 1, 2024
1.5 years
May 13, 2023
February 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
Saroglitazar 4 mg tablets
EXPERIMENTALOral (once daily ) during 364 days/52 weeks of treatment period.
Interventions
Eligibility Criteria
You may qualify if:
- Male and female patients aged ≥18 years
- Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time)
- Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol
- 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:
- Liver stiffness through transient elastography, an LSM ≥8 kPa OR
- Serum ALT ≥45 U/L
You may not qualify if:
- 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
- History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
- Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
- Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
- 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.
- Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.
- Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.
- Pregnant or breast feeding females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Gastroplus Digestive Disease Centre
Ahmedabad, India
Mission GastroHospital
Ahmedabad, India
Artemis Hospital
Gūrgaon, India
Medanta- TheMedicity
Gūrgaon, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dr. Deven Parmar, MD,FCP
Zydus Therapeutics Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2023
First Posted
May 24, 2023
Study Start
July 20, 2023
Primary Completion
January 10, 2025
Study Completion
June 10, 2025
Last Updated
February 7, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share