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

February 3, 2024 updated by: Zydus Lifesciences Limited

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • Ahmedabad, India
        • Recruiting
        • Gastroplus Digestive Disease Centre
        • Contact:
          • Dr. Ravindra Gaadhe
      • Ahmedabad, India
        • Recruiting
        • Mission GastroHospital
        • Contact:
          • Dr Chirag Shah
      • Gurgaon, India
        • Recruiting
        • Artemis Hospital
        • Contact:
          • Dr Pawan Raval
      • Gurgaon, India
        • Recruiting
        • Medanta- TheMedicity
        • Contact:
          • Dr Neeraj Saraf
      • Hyderabad, India
        • Recruiting
        • Malla ReddyNarayanaMultispecialtyHospital
        • Contact:
          • Dr P Kranthi Kumar
      • Hyderabad, India
        • Recruiting
        • Osmania GeneralHospital
        • Contact:
          • Dr B Ramesh Kumar
      • Hyderabad, India
        • Recruiting
        • Yashoda Hospitals
        • Contact:
          • Dr B Ravishankar
      • Indore, India
        • Recruiting
        • CARE CHL -Hospitals (Unit ofConvenient HospitalLtd.
        • Contact:
          • Dr Sandeep Julka
      • Jaipur, India
        • Recruiting
        • S R Kalla MemorialGastro and GenralHospital
        • Contact:
          • Dr Mukesh Kalla
      • Khorda, India
        • Recruiting
        • AIIMS
        • Contact:
          • Dr Manas Kumar Panigrahi
      • Lucknow, India
        • Recruiting
        • Medanta Hospital
        • Contact:
          • Dr Abhai Verma
      • Ludhiāna, India
        • Recruiting
        • Dayanand MedicalCollege & Hospital
        • Contact:
          • Dr Omesh Goyal
      • Ludhiāna, India
        • Recruiting
        • Neurociti Hospital
        • Contact:
          • Dr Nitin Shanker Behl
      • Mumbai, India
        • Recruiting
        • TNMC & BYL NairCh. Hospital
        • Contact:
          • Dr Shubham Jain
      • Nashik, India
        • Recruiting
        • Shree Siddhivinayak Maternity & Nursing Home
        • Contact:
          • Dr Soham Doshi
      • New Delhi, India
        • Recruiting
        • Sir GangaramHospital
        • Contact:
          • Dr Naresh Bansal
      • Panchkula, India
        • Recruiting
        • Alchemist Hospital
        • Contact:
          • Dr Daksh Khurana
      • Rupnagar, India
        • Recruiting
        • Fortis Hospital
        • Contact:
          • Dr Kiran Pal Singh
      • Sūrat, India
        • Recruiting
        • BAPS Pramukh Swami Hospital
        • Contact:
          • Dr. Parshottam Koradia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saroglitazar 4 mg tablets
Oral (once daily ) during 364 days/52 weeks of treatment period.
Drug: Saroglitazar
4 Mg Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in liver stiffness
Time Frame: Baseline to Week 52
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)
Time Frame: Baseline to Week 52
Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in TG, HDL-C, LDL-C and non HDL-C levels
Time Frame: Baseline to Week 24 and Week 52
Baseline to Week 24 and Week 52
Change in serum ALT value
Time Frame: Baseline to Week 24 and Week 52
Baseline to Week 24 and Week 52
Change in serum AST value
Time Frame: Baseline to Week 24 and Week 52
Baseline to Week 24 and Week 52
Change in serum ALP value
Time Frame: Baseline to Week 24 and Week 52
Baseline to Week 24 and Week 52
Change in body weight
Time Frame: Baseline to Week 24 and Week 52
Baseline to Week 24 and Week 52
Change in BMI
Time Frame: Baseline to Week 24 and Week 52
Baseline to Week 24 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zydus Lifesciences Limited

Investigators

  • Study Chair: Dr. Deven Parmar, MD,FCP, Zydus Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Estimated)

January 10, 2025

Study Completion (Estimated)

June 10, 2025

Study Registration Dates

First Submitted

May 13, 2023

First Submitted That Met QC Criteria

May 13, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARO.21.003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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