Safety, Tolerability, and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (NAFLD)

NCT03639623 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: SARO.17.010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD.

Conditions

Liver Transplant; Complications; NAFLD

Keywords

Peroxisome proliferator-activated receptors; NAFLD; NASH; Post Transplant Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events Assessed by CTCAE

  Safety measured by adverse events, vital signs, physical exams, body weight, electrocardiograms (ECGs) and lab results (including hematology, chemistry and urinalysis)

  24 weeks

Secondary Outcomes (28)

• Hepatic Fat

  Baseline and week 24

• Liver Stiffness

  Baseline and Week 24

• Frequently Sampled Intravenous Glucose Tolerance Test (Insulin Resistance Marker)

  Baseline and Week 24

• Glycosylated Hemoglobin (Insulin Resistance Marker)

  Baseline and Week 24

• Fructosamine (Insulin Resistance Marker)

  Baseline and Week 24

Study Arms (1)

Saroglitazar Magnesium 4 mg

EXPERIMENTAL

Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast

Drug: Saroglitazar

Interventions

Saroglitazar DRUG

Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food

Also known as: Not any

Saroglitazar Magnesium 4 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give written informed consent.
• Males or females, 18 to 75 years of age.
• Patients who are at least 6 months post-transplant for nonalcoholic steatohepatitis (NASH) or cryptogenic cirrhosis thought to be secondary to NASH are eligible for enrolment.
• The presence of NAFLD determined by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) prior to enrollment.
• Patients with ≤20% variance in the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin between Visit 1 and Visit 1.1.
• History of medical compliance with immunosuppression.
• Female subjects of non-child bearing potential or on highly effective contraception. For male subjects with female partners of childbearing potential, willing to follow highly effective contraception measures during the study, either by the male participant or his female partner or both.

You may not qualify if:

• Pregnant or lactating females.
• Patient with abnormal transaminases due to secondary intercurrent illness.
• Patients with bile duct strictures.
• Other causes of chronic liver disease after liver transplantation including autoimmune, viral, and alcoholic liver disease.
• Graft cirrhosis as defined by:
• Cirrhosis on historical liver biopsy.
• Evidence of cirrhosis on imaging including portal venous collaterals.
• Prior history of decompensated liver disease including ascites, hepatic encephalopathy or variceal bleeding.
• Evidence of esophageal varices on prior endoscopy.
• Body mass index (BMI) \<18 kg/m².
• Subjects with change in body weight \>5% in the 3 months prior to enrollment.
• Subjects requiring corticosteroid or anticoagulation therapy.
• History of myopathies or evidence of active muscle diseases.
• Unstable cardiovascular disease.
• History of bladder disease and/or hematuria or has current hematuria unless due to a urinary tract infection.

Sponsors & Collaborators

• Zydus Therapeutics Inc.: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

• Bhati C, Idowu MO, Sanyal AJ, Rivera M, Driscoll C, Stravitz RT, Kohli DR, Matherly S, Puri P, Gilles H, Cotterell A, Levy M, Sterling RK, Luketic VA, Lee H, Sharma A, Siddiqui MS. Long-term Outcomes in Patients Undergoing Liver Transplantation for Nonalcoholic Steatohepatitis-Related Cirrhosis. Transplantation. 2017 Aug;101(8):1867-1874. doi: 10.1097/TP.0000000000001709.

  PMID: 28296807 BACKGROUND

• Siddiqui MS, Parmar D, Shaikh F, Forsgren M, Patel S, Bui AT, Boyett S, Patel V, Sanyal AJ. Saroglitazar improves nonalcoholic fatty liver disease and metabolic health in liver transplant recipients. Liver Transpl. 2023 Sep 1;29(9):979-986. doi: 10.1097/LVT.0000000000000110. Epub 2023 Feb 28.

  PMID: 36847136 RESULT

Related Links

• Bhati C, Idowu MO, Sanyal AJ. Long-term Outcomes in Patients Undergoing Liver Transplantation for Nonalc
• Siddiqui MS, Parmar D, Shaikh F, Forsgren M, Patel S, Bui AT, Boyett S, Patel V, Sanyal AJ. Saroglitazar improves nonalcoholic fatty liver disease and metabolic health in liver transplant recipients

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

saroglitazar

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr Deven Parmar
• Organization: Zydus Therapeutics Inc.

dparmar@zydustherapeutics.com

7324050886

Study Officials

• Deven Parmar, MD FCP

  Zydus Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 21, 2018
• Study Start: February 25, 2019
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)