Zydus announces Phase IV EVIDENCES-XI trial to generate RWE of Saroglitazar Mg in NAFLD patients with comorbidities
Phase IV EVIDENCES- XI trial will enroll approximately 1500 NAFLD patients with comorbidities
Zydus Lifesciences announced the commencement of Phase of IV Real World Data Registry trial “EVIDENCES- XI” for Saroglitazar Magnesium in NAFLD patients with comorbidities [ClinicalTrials.gov Identifier: NCT05872269]
The Phase IV EVIDENCES- XI trial will enroll approximately 1500 male and female NAFLD patients with comorbidities (obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome- 200 patients each). The study duration is approximately 56 weeks. The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52.
Dr Rohit Loomba, Professor of Medicine, Division Chief of Gastroenterology at University of California, San Diego School of Medicine and Director of Hepatology at UC San Diego Health will lead the Steering Committee of this Phase IV EVIDENCES- RWD Study.
Dr Loomba mentioned, “This Phase 4 EVIDENCES- study is a landmark study establishing one of the largest prospective registry of patients with Non-Alcoholic Steatohepatitis (NASH) in the world. It will help generate novel Real World Data (RWD) in NAFLD/NASH patients that is especially lacking in Asian populations. Real World Data is crucial to formulate clinical guidelines, to further support its use in clinical practice and this will add to our existing knowledge of Saroglitazar Mg and its role in the management of NAFLD/ NASH.”
Dr Loomba added, “This Phase 4 EVIDENCES- study is a landmark study establishing one of the largest prospective registry of patients with Non-Alcoholic Steatohepatitis (NASH) in the world. It will help generate novel Real World Data (RWD) in NAFLD/NASH patients that is especially lacking in Asian populations. Real World Data is crucial to formulate clinical guidelines, to further support its use in clinical practice and this will add to our existing knowledge of Saroglitazar Mg and its role in the management of NAFLD/ NASH.”
Saroglitazar Mg has been studied in two well controlled Phase 3 clinical trials in patients with NAFLD and NASH in India. The first Phase 3 trial was conducted in biopsy proved NASH patients, where Saroglitazar Mg demonstrated a significant difference of 28 per cent versus placebo in the primary end-point NAFLD Activity