NCT07620366尚未招募2 期
A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis (F2-F3).
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 132
研究概览
简要总结
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial to evaluate efficacy and safety of QL2401 in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis (F2-F3).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18 - 75 years of age inclusive, based on the date of signation of ICF.
- •Presence of type 2 diabetes, or diagnosed at least 1 diseases of obesity, dyslipidemia, hypertension, elevated fasting glucose.
- •Any one criterion as follow:
- •Liver biopsy proved MASH (NAS ≥ 4 with steatosis, ballooning degeneration and lobular inflammation ≥ 1) with fibrosis stage 2 to 3 at screening or within 6 months; or
- •VCTE measured liver stiffness 8.0 kPa ≤ LSM < 20.0 kPa, CAP>302 dB/m.
- •Hepatic fat fraction > 10% measured by MRI-PDFF at screening or within 3 months.
- •Participants using weight loss, blood sugar-lowering, or lipid-regulating medications must maintain a stable dose for ≥3 months before randomization.
- •Participants maintain a stable body weight (±5%) within 2 months prior screening.
排除标准
- •Currently or prior history of hepatocellular carcinoma.
- •Previous or planned liver transplant.
- •History or evidence of any acute or chronic liver disease other than MASH.
- •Cirrhosis with histological records available during screening or prior biopsy (stage 4 fibrosis).
- •Other inclusion and exclusion criteria may apply.
研究者
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