A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities

Phase 4

Recruiting

• Conditions: NAFLD; Type 2 Diabetes; Obesity; Dyslipidemias; Metabolic Syndrome
• Interventions: Drug: Saroglitazar

• Registration Number: NCT05872269
• Lead Sponsor: Zydus Lifesciences Limited

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).

Detailed Description

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).

Total 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).

Study Timeline

• Study First Submitted: 2023-05-13
• Study First Submitted QC: 2023-05-13
• Study First Posted: 2023-05-24
• Study Start: 2023-07-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-03
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-01-10
• Study Completion: 2025-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

   .

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saroglitazar 4 mg tablets	Saroglitazar	Oral (once daily ) during 364 days/52 weeks of treatment period.

Primary Outcome Measures

Name	Time	Method
Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)	Baseline to Week 52
Change in liver stiffness	Baseline to Week 52	liver stiffness measurement performed by transient elastography

Secondary Outcome Measures

Name	Time	Method
Change in body weight	Baseline to Week 24 and Week 52
Change in BMI	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 TG, HDL-C, LDL-C and non HDL-C levels	Baseline to Week 24 and Week 52

Trial Locations

Locations (19)

Gastroplus Digestive Disease Centre; 🇮🇳 Ahmedabad, India

Medanta- TheMedicity; 🇮🇳 Gurgaon, India

Mission GastroHospital; 🇮🇳 Ahmedabad, India

Medanta Hospital; 🇮🇳 Lucknow, India

Artemis Hospital; 🇮🇳 Gurgaon, India

Osmania GeneralHospital; 🇮🇳 Hyderabad, India

S R Kalla MemorialGastro and GenralHospital; 🇮🇳 Jaipur, India

Yashoda Hospitals; 🇮🇳 Hyderabad, India

CARE CHL -Hospitals (Unit ofConvenient HospitalLtd.; 🇮🇳 Indore, India

BAPS Pramukh Swami Hospital; 🇮🇳 Sūrat, India

Alchemist Hospital; 🇮🇳 Panchkula, India

Fortis Hospital; 🇮🇳 Rupnagar, India

Malla ReddyNarayanaMultispecialtyHospital; 🇮🇳 Hyderabad, India

Shree Siddhivinayak Maternity & Nursing Home; 🇮🇳 Nashik, India

AIIMS; 🇮🇳 Khorda, India

Dayanand MedicalCollege & Hospital; 🇮🇳 Ludhiāna, India

Sir GangaramHospital; 🇮🇳 New Delhi, India

Neurociti Hospital; 🇮🇳 Ludhiāna, India

TNMC & BYL NairCh. Hospital; 🇮🇳 Mumbai, India