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

Obesity Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872269
• Other study ID #: SARO.21.003
• Status: Recruiting
• Phase: Phase 4
• Start date: July 20, 2023
• Est. completion date: June 10, 2025

Study information

• Verified date: February 2024
• Source: Zydus Lifesciences Limited
• Contact: Dr Kevin Kansagra, MD
• Phone: 02717-665555
• Email: kevinkumarkansagra[@]zyduslife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 10, 2025
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemias
• Metabolic Syndrome
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Obesity
• Syndrome
• Type 2 Diabetes

Intervention

Drug:
• Saroglitazar
4 Mg Oral Tablet

Locations

Country	Name	City	State
India	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	Ludhiana
India	Neurociti Hospital	Ludhiana
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	Surat

Sponsors (1)

Lead Sponsor	Collaborator
Zydus Lifesciences Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in liver stiffness	liver stiffness measurement performed by transient elastography	Baseline to Week 52
Primary	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
Secondary	Change in serum ALT value		Baseline to Week 24 and Week 52
Secondary	Change in serum AST value		Baseline to Week 24 and Week 52
Secondary	Change in serum ALP value		Baseline to Week 24 and Week 52
Secondary	Change in body weight		Baseline to Week 24 and Week 52
Secondary	Change in BMI		Baseline to Week 24 and Week 52