NCT07335601招募中2 期
Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate MGL-3196 (Resmetirom) in Patients With MASH Who Have Undergone Liver Transplant for MASH Cirrhosis or Other Etiologies
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 19
- 主要终点
- Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28
研究概览
简要总结
A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Cohort 1 will consist of patients who have undergone liver transplant for MASH cirrhosis who developed recurrent MASH. Cohort 2 will consist of subjects who have undergone liver transplant for indications other than MASH cirrhosis who developed de novo MASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •At least 12 months post-liver transplant at screening and meeting one of the following:
- •Cohort 1: Liver transplant for MASH cirrhosis with recurrent hepatic steatosis ≥8% by MRI-PDFF
- •Cohort 2: Liver transplant for non-MASH etiology with de novo hepatic steatosis ≥8% by MRI-PDFF
- •Presence of at least one metabolic risk factor, including overweight/obesity, dysglycemia or type 2 diabetes, hypertension or antihypertensive treatment, hypertriglyceridemia or low HDL cholesterol, or lipid-lowering therapy.
- •MASH with moderate to advanced liver fibrosis (F2-F3), confirmed by noninvasive fibrosis assessment (FibroScan and/or MRE) and a liver biopsy consistent with Stage F2/F3 MASH and no evidence of other liver pathology or graft rejection.
- •Stable renal function with estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² prior to and during screening.
- •Stable liver enzymes at screening, without clinically significant worsening compared with recent historical values.
- •Stable immunosuppressive regimen for at least 3 months prior to screening.
- •Females of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use effective contraception during the study and for at least 30 days after the last dose; females not of childbearing potential are eligible.
排除标准
- •Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.
- •Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.
- •FibroScan VCTE >20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE > 5 kPa.
- •Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.
- •Evidence of active liver disease other than MASH.
- •History of liver transplantation for an inborn error of metabolism.
- •Evidence of hepatic impairment or decompensation at screening.
- •Steroid resistant rejection of the transplanted liver or kidney, or a history of a rejection treated with high dose steroid within 3 months of screening.
- •Chronic rejection or chronic plasma-cell hepatitis.
- •Significant post-transplant vascular or biliary complications.
- •Significant cardiovascular or cerebrovascular disease within 6 months prior to randomization.
- •Uncontrolled hypertension at screening or randomization.
- •Current hepatocellular carcinoma.
- •Known human immunodeficiency virus (HIV) infection or other clinically significant immunocompromised state.
- •Any serious medical condition with a life expectancy of less than 5 years.
- •Current substance abuse or drug addiction.
- •Significant psychiatric, cognitive, or social conditions that would interfere with study participation or compliance, in the Investigator's judgment.
- •Known hypersensitivity to study drug or any of its excipients.
- •Use of prohibited concomitant medications that may affect liver function, steatosis, thyroid function, or study outcomes, or unstable doses of allowed metabolic therapies prior to randomization.
- •Use of statins above protocol-allowed doses or unstable lipid-lowering therapy prior to randomization.
- •Contraindications to MRI, including implanted devices incompatible with MRI, severe claustrophobia, or inability to undergo MRI procedures.
研究组 & 干预措施
Arm 3: Placebo - Cohort 1
Placebo Comparator
干预措施: Placebo (Drug)
Arm 2: Resmetirom 80 or 100 mg daily - Cohort 2
Active Comparator
干预措施: Resmetirom (Drug)
Arm 4: Placebo - Cohort 2
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1: Resmetirom 80 or 100 mg daily - Cohort 1
Active Comparator
干预措施: Resmetirom (Drug)
结局指标
主要结局
Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28
时间窗: 28 weeks
To determine the effect of MGL-3196/Resmetirom versus matching placebo on percent change from Baseline to Week 28 in hepatic fat fraction by magnetic resonance imaging proton density fat fraction (MRI-PDFF) in patients with baseline MRI-PDFF ≥8%.
次要结局
- To evaluate the safety and tolerability of once-daily, oral administration of MGL-3196/resmetirom versus matching placebo in patients who have undergone a liver transplant(52 weeks)
- 1.To determine the effect of MGL-3196/resmetirom versus matching placebo on liver stiffness as measured by FibroScan vibration controlled transient elastography (VCTE; kPa)(28 and 52 Weeks)
- 2. To determine the effect of MGL-3196/resmetirom versus matching placebo on serum lipid parameters(28 and 52 Weeks)
- 3. To determine the effect of MGL-3196/resmetirom versus matching placebo on liver biochemistries(28 and 52 weeks)
研究者
研究点 (19)
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