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

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ClinicalTrials.gov Identifier: NCT05872269
Recruitment Status : Recruiting
First Posted : May 24, 2023
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Zydus Lifesciences Limited

Study Description
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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).

Condition or disease Intervention/treatment Phase
NAFLD Obesity Type 2 Diabetes Dyslipidemias Metabolic Syndrome Drug: Saroglitazar Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 20, 2023
Estimated Primary Completion Date : January 10, 2025
Estimated Study Completion Date : June 10, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in liver stiffness [ Time Frame: Baseline to Week 52 ]
    liver stiffness measurement performed by transient elastography

  2. Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) [ Time Frame: Baseline to Week 52 ]

Secondary Outcome Measures :
  1. Change in TG, HDL-C, LDL-C and non HDL-C levels [ Time Frame: Baseline to Week 24 and Week 52 ]
  2. Change in serum ALT value [ Time Frame: Baseline to Week 24 and Week 52 ]
  3. Change in serum AST value [ Time Frame: Baseline to Week 24 and Week 52 ]
  4. Change in serum ALP value [ Time Frame: Baseline to Week 24 and Week 52 ]
  5. Change in body weight [ Time Frame: Baseline to Week 24 and Week 52 ]
  6. Change in BMI [ Time Frame: Baseline to Week 24 and Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    .

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05872269


Contacts
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Contact: Dr Kevin Kansagra, MD 02717-665555 ext 451 kevinkumarkansagra@zyduslife.com

Locations
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Sponsors and Collaborators
Zydus Lifesciences Limited
Investigators
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Study Chair: Dr. Deven Parmar, MD,FCP Zydus Therapeutics Inc.
More Information
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Responsible Party: Zydus Lifesciences Limited
ClinicalTrials.gov Identifier: NCT05872269    
Other Study ID Numbers: SARO.21.003
First Posted: May 24, 2023    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zydus Lifesciences Limited:
Real World Evidence Study
Additional relevant MeSH terms:
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Non-alcoholic Fatty Liver Disease
Obesity
Diabetes Mellitus, Type 2
Metabolic Syndrome
Dyslipidemias
Syndrome
Disease
Pathologic Processes
Overweight
Overnutrition
Nutrition Disorders
 Body Weight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Lipid Metabolism Disorders
Fatty Liver
Liver Diseases
Digestive System Diseases