A Multicentric, prospective, open-label clinical trial to assess the efficacy and safety of Saroglitazaar Magnesium 4mg along with the standard of care, in the treatment of hepatic steatosis and fibrosis, in comparison to Ursodeoxycholic acid along with standard of care, in people living with Type 2 Diabetes Mellitus and/or Metabolic dysfunction-associated steatotic liver disease.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 5
研究概览
简要总结
Our study aims to compare the efficacy and safety of two drugs in the treatment of Metabolically Associated Steatotic Liver Disease (MASLD). One of the drugs is Saroglitazar Magnesium 4mg, which DCGI has already approved for use in MASLD. Another drug is ursodeoxycholic acid, which has not shown any significant improvement in the treatment of MASLD and is not recommended for MASLD by any organisation. It will be used as a comparator drug. The drugs will be used in patients of MASLD with Fibroscan reports showing either Grade 3 steatosis and/ or more than or equal to stage 2 fibrosis. The follow-up will last 6 months per protocol, and a repeat fibroscan will be performed at the end of the trial. The primary objective of the study is to assess improvements in liver steatosis and fibrosis based on the FibroScan report. The secondary aim will be to determine the effects of the drugs on liver function tests, lipid profile, glucose parameters, and platelet count.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •People having Type 2 Diabetes Mellitus and /or at least one of the four parameters of Metabolic Syndrome: Hypertension ( or taking any drugs for hypertension ), obesity, high triglyceride ( or taking any medications for dyslipidemia), and low HDL.
- •A diagnosis of liver steatosis stage 3 (S3) and/or fibrosis ( F2F3F4) established by Vibration Controoled Transient Elastography using Fibroscan.
排除标准
- •Having an established diagnosis of Cirrhosis
- •Person with T1DM
- •Person with greater than S3 steatosis if LSM is greater than 8kPa on VCTE
- •Person already on Thiazolidinediones, Vitamin E
- •A person taking alcohol in a quantity more than the standard limits set by AASLD (Asia Pacific region)
- •Person having positive HBsAg or anti-HCV
- •People on steatogenic drugs like amiodarone.
- •Methotrexate, oral contraceptives, and steroids
- •People with other causes of liver disease, e.g., Wilsons Disease, Autoimmune Disease, alcoholic liver disease
- •Pregnant and lactating females
- •People with underlying diseases like acute viral hepatitis.
- •congestive hepatomegaly, or biliary congestion, can disturb the estimation done by VCTE
- •A person having any other severe illness that may render the follow-up difficult 14.
研究者
DINESH KUMAR
Harsha Clinic and Diabetes Centre