Evaluating Saroglitazar for treating 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)

This study is testing if a new medication called Saroglitazar can help people with non-alcoholic fatty liver disease and other health issues like obesity and diabetes feel better and improve their liver health.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 1500 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zydus Lifesciences Limited (industry)
• Locations: 19 sites (Ahmedabad and 18 other locations)
• Trial ID: NCT05872269 on ClinicalTrials.gov

What this trial studies

This Phase 4, non-randomized, multicentre, open-label, single-arm study aims to assess the safety and efficacy of Saroglitazar 4 mg in patients diagnosed with non-alcoholic fatty liver disease (NAFLD) who also have comorbidities such as obesity, type 2 diabetes, dyslipidemia, or metabolic syndrome. The study will enroll 1500 male and female participants aged 18 and older who are prescribed Saroglitazar for the first time. Participants will be monitored for long-term outcomes related to their liver health and associated metabolic conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a documented diagnosis of NAFLD and at least one comorbidity such as obesity or type 2 diabetes.

Not a fit: Patients who consume alcohol excessively or have other causes of chronic liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from NAFLD and its associated comorbidities.

How similar studies have performed: Other studies have shown promise in treating NAFLD with similar pharmacological approaches, but this specific evaluation of Saroglitazar is novel.

Eligibility criteria

Inclusion Criteria:

1. Male and female patients aged ≥18 years
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

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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:

1. 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
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

Where this trial is running

Ahmedabad and 18 other locations

• Gastroplus Digestive Disease Centre — Ahmedabad, India (RECRUITING)
• Mission GastroHospital — Ahmedabad, India (RECRUITING)
• Artemis Hospital — Gurgaon, India (RECRUITING)
• Medanta- TheMedicity — Gurgaon, India (RECRUITING)
• Malla ReddyNarayanaMultispecialtyHospital — Hyderabad, India (RECRUITING)
• Osmania GeneralHospital — Hyderabad, India (RECRUITING)
• Yashoda Hospitals — Hyderabad, India (RECRUITING)
• CARE CHL -Hospitals (Unit ofConvenient HospitalLtd. — Indore, India (RECRUITING)
• S R Kalla MemorialGastro and GenralHospital — Jaipur, India (RECRUITING)
• AIIMS — Khorda, India (RECRUITING)
• Medanta Hospital — Lucknow, India (RECRUITING)
• Dayanand MedicalCollege & Hospital — Ludhiāna, India (RECRUITING)
• Neurociti Hospital — Ludhiāna, India (RECRUITING)
• TNMC & BYL NairCh. Hospital — Mumbai, India (RECRUITING)
• Shree Siddhivinayak Maternity & Nursing Home — Nashik, India (RECRUITING)
• Sir GangaramHospital — New Delhi, India (RECRUITING)
• Alchemist Hospital — Panchkula, India (RECRUITING)
• Fortis Hospital — Rupnagar, India (RECRUITING)
• BAPS Pramukh Swami Hospital — Sūrat, India (RECRUITING)

Study contacts

• Study coordinator: Dr Kevin Kansagra, MD

Conditions: NAFLD, Obesity, Type 2 Diabetes, Dyslipidemias, Metabolic Syndrome, Real World Evidence Study