NCT06692283撤回3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD)/Metabolic Dysfunction-Associated Steatohepatitis (MASH)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 2,000
- 主要终点
- Primary Safety Outcome Measure: TEAEs
研究概览
简要总结
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease (MALSD)/metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment.
详细描述
Up to 2000 patients will be randomized to receive either denifanstat 50 mg or placebo.
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
- Double (Participant, 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
- •Willing and able to participate in the study and provide written informed consent.
- •Adults between 18 and 75 years of age.
- •Body mass index (BMI) ≥23 kg/m2 for Asian patients and ≥25 kg/m2 for patients of other races.
- •Presence of metabolic risk factor(s), as follows:
- •At least 2 out of 4 of the following:
- •BMI ≥30 kg/m2,
- •Hypertension, or on active antihypertensive treatment
- •Elevated fasting serum TGs or on active treatment for hypertriglyceridemia
- •Reduced fasting serum HDL-c, or on active treatment for dyslipidemia.
- •For patients with T2DM:
- •HbA1c ≤9.5%
- •If treatment naive: patients must have been diagnosed for at least 12 weeks prior to screening
- •Suspected or confirmed diagnosis of MASH or MASLD or non-invasively diagnosed MASH or MASLD
- •Stable ALT and AST levels
排除标准
- •Previous intake of an approved MASH medication
- •Exclusionary laboratory values:
- •ALT and/or AST >5 × ULN.
- •ALP ≥2 × ULN.
- •Total serum bilirubin concentration >1.3 mg/dL.
- •Serum albumin concentration <3.5 g/dL.
- •International normalized ratio (INR) >1.3, except for patients receiving anticoagulant treatment.
- •Platelet count <140,000/μL.
- •Fasting TG level ≥500 mg/dL.
- •eGFR <45 mL/min/1.73 m
- •History of excessive alcohol intake for a period of more than 3 consecutive months within 1 year prior to screening.
- •Presence of cirrhosis on liver histology and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension.
- •Current or historical clinically evident hepatic decompensation.
- •Evidence of another form of active liver disease.
- •Positive serologic evidence of current infectious liver disease.
- •MELD score ≥
- •Planned or history of liver transplantation.
- •Prior or planned bariatric surgery.
- •Gain or loss of >5% of body weight in the 3 months or >10% of body weight in the 6 months prior to screening, qualifying liver biopsy, and the baseline visit (V1).
- •Any of the following conditions or procedures within 6 months prior to the baseline visit (V1):
- •Myocardial infarction
- •Cardiac revascularization surgery
- •Unstable angina
- •Transient ischemic attack, stroke, or cerebrovascular disease
- •Unstable or undiagnosed arrhythmias.
- •Uncontrolled high BP.
- •Malignancy with a complete remission date within 5 years prior to the baseline visit (V1).
- •Any current or history of hepatocellular carcinoma.
- •Diabetes other than T2DM
- •Uncontrolled hypothyroidism.
- •Any other known serious disease or other disease which in the Investigator's opinion would exclude the patient from participating in the study.
- •Use of a nonpermitted concomitant medication within 30 days or 5 half-lives prior to screening.
研究组 & 干预措施
Denifanstat 50 mg
Experimental
Denifanstat tablet, orally, once daily
干预措施: denifanstat (Drug)
Placebo
Placebo Comparator
Placebo tablet, orally, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Safety Outcome Measure: TEAEs
时间窗: 52 weeks
Incidence of treatment-emergent adverse events (TEAEs) in patients with MASLD/MASH treated with denifanstat 50 mg compared to placebo after 52 weeks of treatment.
次要结局
未报告次要终点
研究者
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