Efficacy and Safety of Dapagliflozin compared to Saroglitazar in patients with Metabolic dysfunction associated steatotic liver disease (MASLD): A non-inferiority, randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 1
研究概览
简要总结
MASLD is an increasingly prevalent chronic liver condition associated with insulin resistance, dyslipidemia and obesity. There are currently no FDA approved pharmacological therapies for MASLD. Saroglitazar, a dual PPAR alpha gamma agonist, has shown beneficial effects on liver fat, glycemic control and lipid parameters in MASLD and NASH in Indian studies. Similarly, dapagliflozin has shown improvements in liver fat, body weight and metabolic parameters in patients with type 2 diabetes and MASLD. Direct comparative evidence between these two agents is limited. This randomized non inferiority study aims to compare the efficacy and safety of dapagliflozin 10 mg once daily and saroglitazar 4 mg once daily over 24 weeks in patients with MASLD. The study will assess changes in liver enzymes, non invasive fibrosis and steatosis indices, metabolic and anthropometric parameters, lipid and glucose profiles, blood pressure and quality of life.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •A.Evidence of Hepatic Steatosis Confirmed through imaging techniques (such as ultrasound, CT, MRI) or histology (biopsy) and presence of at least 1 out of 5 Cardiometabolic Risk Factor.
- •Cardiometabolic risk factors include- 1.Overweight/Obesity: BMI more than and equal to 25 kg/m² (more than and equal to 23 kg/m² for Asian populations), or waist circumference more than 94 cm (men) or more than 80 cm (women), with ethnicity-adjusted thresholds where applicable 2.Impaired Glucose Metabolism: Fasting glucose more than and equal to 100 mg/dL (5.6 mmol/L), 2-hour post-load glucose more than and equal to 140 mg/dL (7.8 mmol/L), HbA1c more than and equal to 5.7percent, or diagnosed type 2 diabetes mellitus (or its treatment) 3.Hypertension: Blood pressure more than and equal to 130/85 mmHg, or ongoing antihypertensive therapy 4.Hypertriglyceridemia: Triglycerides more than and equal to 150 mg/dL (1.70 mmol/L) or use of lipid-lowering therapy 5.Low HDL Cholesterol: HDL less than and equal to 40 mg/dL (men) or less than and equal to 50 mg/dL (women), or on lipid-lowering treatment B.Patient’s willingness to comply with the study protocol and prior written informed consent.
排除标准
- •i) Patients with alternate causes of fatty liver including:- a) Patients on TPN and those who underwent surgical procedures within 90 days from randomization b) presence of other chronic liver disease such as hepatitis B or C, liver cirrhosis, Wilson’s disease or any other autoimmune condition leading to fatty liver c) use of following drugs for more than 3 months over past 1 year before visit 1 including: Amiodarone, Tamoxifen, Methotrexate, Systemic glucocorticoids, Anabolic steroids, Tetracycline, Estrogen, Vitamin A, Asparagine, Valproate, Chloroquine, ARVs ii) Use of drugs with potential effect on MASLD such as: Ursodeoxycholic acid, S- Adenosyl Methionine(SAM-e), Betaine, Pentoxyfylline, Obeticholic acid, milk thistle, Vitamin E, statins, CYP3C8 inhibitors or substrate -within 3 months before visit 1 iii) Presence of bleeding disorders, myopathy, malignancy, hypothyroidism iv) Presence of anaemia, acute or chronic kidney disease, acute or chronic liver disease, heart failure v) Participant with body weight of more than 30kg/m2 vi)Participation in other MASLD/MASH related study within last 3 months vii) Pregnant or lactating females or couples planning pregnancy within 3 months.
研究者
Dr Nishi
Indira Gandhi Institute of Medical Sciences