NCT06939816招募中2 期
A Study to Assess the Effect of Vonafexor on Kidney Function in Subjects With Impaired Renal Function and Suspected MASH
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Enyo Pharma
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline of mGFRiohexol at week 16
研究概览
简要总结
This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH. In addition, the non-invasive multiparametric magnetic resonance imaging assessment of functional and structural changes in the kidney and in the liver will be investigated.
详细描述
This is a phase 2, open-label, two-dose, randomized, parallel arms, single center study where subjects are participating for up to 32 weeks:
- Screening: 4 weeks
- Treatment: 16 weeks
- Follow-up: 12 weeks
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
- 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
- •Signed and dated informed consent obtained before any trial-related activities
- •Male or female subject.
- •Age between 18 and 75 years, both inclusive.
- •Overweight or obesity (body mass index BMI ≥ 25.0 kg/m2 and ≤ 45.0 kg/m2) with or without type 2 diabetes mellitus (T2DM with an HbA1c ≤ 9.5%).
- •eGFR ≥ 30 and < 90 (mL/min/1.73 m²).
- •Presumed mild to higher liver fibrosis as shown by a FIBROTEST score ≥ 0.28 and/or FIB-4 score ≥ 1.3.
排除标准
- •Known or suspected hypersensitivity to IMP or any of the excipients or to any component of the IMP formulation.
- •Previous participation in this trial. Participation is defined as randomised.
- •Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
- •History of multiple and/or severe allergies to drugs including contrast media or foods or a history of severe anaphylactic reaction.
- •Known non-MASH liver disease.
- •History or presence of cirrhosis (evidenced on imaging or by histology, or liver decompensation, including ascites, hepatic encephalopathy, or presence of esophageal varices).
- •Total body weight loss of >5% within 6 months prior to screening.
- •If female, pregnancy or breast-feeding.
- •Women of childbearing potential who are not using a highly effective contraceptive method and whose male partner is not using a highly effective contraceptive method for the entire study duration and for at least 6 weeks after last dosing
研究组 & 干预措施
Vonafexor low dose
Experimental
Vonafexor low dose 1 tablet per day
干预措施: Vonafexor low dose (Drug)
Vonafexor high dose
Experimental
Vonafexor high dose 1 tablet per day
干预措施: Vonafexor high dose (Drug)
结局指标
主要结局
Change from baseline of mGFRiohexol at week 16
时间窗: 16 weeks
Change from baseline of eGFRcreatinine at week 16
时间窗: 16 weeks
次要结局
- Vonafexor plasma concentrations(16 weeks)
- Change from baseline mGFRiohexol off treatment at week 24(24 weeks)
- Change from baseline of eGFRcreatinine on treatment at weeks 4, 8, 12 and off treatment at weeks 20, 24 and 28(28 weeks)
- Correlation of mGFRiohexol with eGFRcreatinine at baseline, on treatment at week 16 and off treatment at week 24(24 weeks)
- Levels and change in proteinuria in morning urine samples at baseline, on treatment at weeks 4, 8, 12, 16 with off treatment at weeks 20, 24 and 28(28 weeks)
- Treatment-emergent adverse events and serious adverse events(28 weeks)
研究者
研究点 (1)
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