A Randomized Controlled Trial Assessing the Efficacy and Safety of Resmetirom 80 mg Versus Saroglitazar 4 mg with AI-Enabled Digital Lifestyle Support in MASLD Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Change in Liver Stiffness Measurement LSM score measured by FibroScan
研究概览
简要总结
A Randomized Controlled Trial Assessing the Efficacy & Safety of Resmetirom 80mg Versus Saroglitazar 4 mg with AI-Enabled Digital Lifestyle Support in MASLD Patients in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease MASLD. A total of 334 participants will be enrolled and randomly assigned in a 2 to 1 ratio to receive either Resemeritom 80mg or Saroglitizar 4 mg for a duration of 180 days. The study aims to assess changes in liver stiffness and steatosis using FibroScan along with improvements in metabolic health indicators such as BMI lipid profile HbA1C and blood pressure. Quality of life and safety will also be evaluated throughout the study period. The primary outcome is the change in liver stiffness and CAP scores from baseline to day 180. Secondary outcomes include changes in metabolic markers liver function tests and adverse events. Participants will undergo periodic assessments during scheduled visits including baseline day 30 day 60 day 90 day 135 and end of study on day 180.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and female participants aged between more than 18 and less than or equal to 60 years.
- •Participants who are diagnosed with Metabolic dysfunction-associated steatotic liver disease (MASLD) defined as hepatic steatosis in adults (detected either by imaging techniques by biopsy) in addition to one of the following criteria’s namely A.
- •BMI more than or equal to 25 kg per m2 [23 kg per m2 in Asians] OR Waist circumference (WC) more than 94 cm (Male) 80 cm (Female) OR ethnicity adjusted.
- •Fasting serum glucose more than 5.6 mmol per Litre [100 mg per dL] OR 2-hour post load glucose levels more than or equal to 7.8 mmol per Litre[more than or equal to 140 mg per dL] OR HbA1c more than or equal to 5.7% [39 mmol per Litre) OR type 2 diabetes OR treatment for type 2 diabetes.
- •Blood pressure more than or equal to sysBP130 DysBP 85 mmHg OR specific antihypertensive drug treatment.
- •Plasma triglycerides more than or equal to more than or equal to 1.70 mmol per L [150 mg per dL] OR lipid lowering treatment.
- •Plasma HDL-cholesterol less than or equal to 1.0 mmol per Litre [40 mg per Deci Litre] (M) and more than or equal to 1.3 mmol per Litre [50 mg per dL] (F) OR lipid lowering treatment.
- •Non-invasive FIBROSCAN confirmed hepatic steatosis and stiffness as defined below, A.
- •Liver Stiffness Measurement (LSM) score of more than or equal to 8 to less than or equal to 12 Kpa as per Vibration Controlled Transient Elastography (VCTE).
- •Any grade of steatosis (S1-S3) as determined by Continuous Attenuation Parameter (CAP).
- •(S1-mild: more than or equal 248 dB per m, S2-moderate:more than or equal 268 dB per m, S3- severe: more than or equal 280 dB per m).
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
- •Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation or remaining celibate by choice) who meets the following criteria: a.
- •Has not undergone a hysterectomy or bilateral oophorectomy; or b.
- •Has not attained menopause (Women not menstruating for at least 12 consecutive months).
- •Male participants who are willing to refrain from donating sperm from first admission to the study until 90 days after the study completion.
排除标准
- •FibroScan LSM more than to 12.5 kPa biopsy-proven advanced fibrosis, or cirrhosis or related complications.
- •Co-existing chronic liver diseases (e.g., viral hepatitis, autoimmune, DILI, hemochromatosis).
- •Uncontrolled serious illnesses (e.g., severe anemia, CVD, psychiatric, malignancy), PT-INR more than 1.
- •Muscle Disorders or Myopathies Bariatric surgery within 1 year, or prior participation in similar studies within 3 months.
- •Any concomitant serious disorders like chronic kidney disease, cardiovascular diseases, pulmonary disease, and use of chemotherapy agents or history of cancer.
- •Gravid women and lactating mother.
- •Heavy smoker, Chronic alcoholic, or drug abuse subjects
- •Known cases of malignancy, HIV infection, AIDS, etc.
- •Participants are not willing to sign the ICF and to attend the treatment schedule regularly.
结局指标
主要结局
Change in Liver Stiffness Measurement LSM score measured by FibroScan
时间窗: Measured at Baseline and week 24
Change in Controlled Attenuation Parameter CAP score measured by FibroScan
时间窗: Measured at Baseline and week 24
次要结局
- Change in body mass index(Change in waist circumference)
研究者
Mothish waran B
SRM Institute of Science and Technology