NCT06934642招募中1 期
Effect of Tirzepatide on Markers of MASLD in Patients With Obesity: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Biomarkers associated with MASLD
研究概览
简要总结
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease worldwide and predominately affects individuals with overweight and obesity, as well as those with type 2 diabetes and cardiovascular disease. Tirzepatide is a medication used to treat type 2 diabetes and obesity. It has also been shown to help with MASLD. The purpose of this study is to study how tirzepatide affects the liver in patients with MASLD.
Participants will be asked to:
- Take tirzepatide for 12 months.
- Come in for clinic visits every 3 months.
- Have blood drawn at baseline, 6, and 12 months.
- Complete a liver ultrasound at baseline and at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Age 18-75
- •Diagnosis of MASLD based on the following criteria:
- •Presence of at least 1 out of the 5 following cardiometabolic criteria:
- •BMI >25 kg/m2 OR waist circumference >94 cm (men) or 80cm (women)
- •Fasting serum glucose >100 mg/dL OR 2-hour post-prandial glucose levels >140mg/dL OR AbA1c >5.7% OR type 2 diabetes OR treatment for type 2 diabetes
- •Blood pressure >130/85 mmHg OR specific antihypertensive drug treatment
- •Plasma triglycerides >150mg/dL OR on lipid lowering treatment
- •Plasma HDL-cholesterol <40mg/dL (men) and <50mg/dL (women) OR on lipid lowering medication
- •No other identified causes of steatosis
- •Evidence of steatotic liver disease (hepatic steatosis identified by imaging or biopsy)
- •English speaking
排除标准
- •Pregnancy or breast feeding
- •Premenopausal women not on any form of contraception
- •Reports alcohol intake >50g/day or 350g/week for women and >60g/day or 420g/week for men or an AUDIT score >8
- •Other identifiable causes of steatosis
- •Documented allergic reaction to tirzepatide or any other GLP1 RA
- •Decompensated liver disease
- •Decompensated renal disease requiring hemodialysis
- •Decompensated heart failure
- •Active malignancy
- •Prior history of pancreatitis
- •Serum triglyceride levels >500 mg/dL
- •Personal or family history of medullary thyroid cancer or MEN2a or MEN2b
- •Concurrent use of other ant-obesity medications
- •Use of other GLP1 RAs within 3 months of study enrollment
- •Unable to obtain the medication due to cost or insurance coverage restrictions.
研究组 & 干预措施
Intervention Arm
Experimental
Individuals in the intervention arm (only arm) will receive tirzepatide for 12 months.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Biomarkers associated with MASLD
时间窗: 12 months
Identification of an changes in biomarkers associated with MASLD with tirzepatide use
次要结局
- Liver Fat Content(12 months)
- Liver Stiffness(12 months)
- Body weight(12 months)
- Metabolic markers(12 months)
研究者
研究点 (1)
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