NCT06903065进行中（未招募）1 期
A Phase Ib, Multicenter, Open-Label, Single-Arm Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Patients With Advanced MASH Liver Fibrosis
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 33
- 主要终点
- Percentage of Participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and activity of RO7790121 in participants with advanced metabolic dysfunction-associated steatohepatitis (MASH) fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Body mass index within the range of >= 25 and <=45 kilograms per square meter (kg/m^2)
- •MASH with fibrosis score of F3 or F4 confirmed by transient elastography measurement >=12.0 kPa and <=25.0 kPa
- •Agreement to adhere to the contraception requirements
排除标准
- •Weight gain or loss >5% in the 3 months prior to baseline or >10% in the 6 months prior to baseline
- •Bariatric surgery within 1 year prior to baseline
- •Current signs or prior history of decompensated liver disease
- •Complications or clinical evidence of portal hypertension
- •Lack of peripheral venous access
- •Other causes of liver disease based on medical history and/or centralized review of liver histology
- •History of liver transplantation
- •Current or prior history of hepatocellular carcinoma (HCC)
- •Uncontrolled hypertension
- •Concomitant Type 1 diabetes, or Type 2 diabetes with HbA1c >10%
- •History of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- •Current, significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening
- •Initiation of a medication of an antidiabetic, weight loss, lipid-modifying or anti-depressant drug class
- •Active tuberculosis requiring treatment within the 12 months prior to baseline
- •History of organ transplant
研究组 & 干预措施
RO7790121
Experimental
Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections.
干预措施: RO7790121 (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events (AEs)
时间窗: Up to Week 52 after Baseline
次要结局
- Change from Baseline in Liver Stiffness(Baseline to Week 52)
- Change from Baseline in Serum Levels of Propeptide of Type lll Collagen (Pro-C3)(Baseline to Week 52)
- Change from Baseline in Serum Enhanced Liver Fibrosis (ELF) Test(Baseline to Week 52)
- Change from Baseline in Fibro-inflammation(Baseline to Weeks 52)
- Pre-dose Concentrations of RO7790121(Weeks 0, 2, 6, 10, 14, 26, and 38)
- Maximum Concentration (Cmax) of RO7790121(Weeks 0, 2, 6, 10, 52 and 62)
- Minimum Concentration (Cmin) of RO7790121(Weeks 0, 2, 6, 10, 52 and 62)
研究者
研究点 (33)
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