NCT06937749招募中2 期
A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be willing to participate in the study and provide written informed consent.
- •Male or female, age 18 years or older at the time of signing informed consent
- •Body mass Index (BMI) ≥25 kg/m²
- •Diagnosis of Metabolic dysfunction-associated steatohepatitis (MASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) ≥ 4, with at least 1 point in steatosis, inflammation and ballooning each) and fibrosis stage F2 or F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 3 months prior to screening
排除标准
- •Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
- •History or current other forms of chronic liver disease other than MASH
- •Patients with positive Hepatitis B surface antigen (HBsAg). Patients with positive HBcAb will be eligible only when HBV DNA test negative at screening
- •patients with HCV antibody positive.
- •Patients with HIV antibody positive or syphilis specific antibodies positive (patients with non-specific antibody turned negative will be eligible)
- •Model for End-stage Liver Disease(MELD) >12 or Child-Turcotte-Pugh(CTP) >6
研究组 & 干预措施
IBI362 Low Dose
Experimental
Dose level 1,SC,once a week for 4 weeks; Dose level 2,SC,once a week for 4 weeks; Dose level 3,SC,once a week for 52 weeks
干预措施: IBI362 (Drug)
IBI362 High Dose
Experimental
Dose level 1,SC,once a week for 4 weeks; Dose level 2,SC,once a week for 4 weeks; Dose level 3,SC,once a week for for 4 weeks; Dose level 4,SC,once a week for 48 weeks
干预措施: IBI362 (Drug)
Placebo
Placebo Comparator
Placebo,SC,once a week for 60 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
时间窗: Baseline, Week 60
次要结局
- Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology(Baseline, Week 60)
- Percentage of Participants With MASH improvement With no Worsening of Fibrosis on Liver Histology(Baseline, Week 60)
- Percentage of Participants With MASH improvement With ≥1 Point Decrease in Fibrosis Stage on Liver Histology(Baseline, Week 60)
- Percentage of Participants With MASH resolution With ≥1 Point Decrease in Fibrosis Stage on Liver Histology(Baseline, Week 60)
- Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage on Liver Histology(Baseline, Week 60)
- Mean Absolute Change and Percentage Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)(Baseline, Week 4, Week 12, Week 36, Week 60)
- Percentage of participants with at least 30%, 50% and 70% relative reduction in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) From Baseline(Baseline, Week 4, Week 12, Week 36, Week 60)
- Mean Absolute Change and Percentage change From Baseline in aspartate aminotransferase[U/L](Baseline, Week 36, Week 60)
- Mean Absolute Change and Percentage change From Baseline in alanine aminotransferase[U/L](Baseline, Week 36, Week 60)
- Mean Absolute Change and Percentage change From Baseline in a γ-Glutamyl transferase[U/L](Baseline, Week 36, Week 60)
- Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L](Baseline, Week 36, Week 60)
- Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L](Baseline, Week 36, Week 60)
- Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L](Baseline, Week 36, Week 60)
- Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L](Baseline, Week 36, Week 60)
- Mean Absolute Change and Percent Change from Baseline in Body Weight [kg](Baseline, Week 36, Week 60)
- Percentage of Participants who Achieve ≥5%, ≥10% and ≥15% Body Weight Reduction(Baseline, Week 36, Week 60)
- Mean Absolute Change from Baseline in BMI [kg/m2](Baseline, Week 36, Week 60)
- Mean Absolute Change from Baseline in Waist Circumference [cm](Baseline, Week 36, Week 60)
- Mean Absolute Change from Baseline in Fasting Plasma Glucose (FPG )[mmol/L(Baseline, Week 36, Week 60)
- Mean Absolute Change from Baseline in glycated hemoglobin A1c (HbA1c)[%](Baseline, Week 36, Week 60)
- Change from Baseline in Homeostasis Model Assessment IR(Baseline, Week 36, Week 60)
- Changes from baseline in scores in 36-item Short-Form Health Survey version 2(SF-36v2)(Baseline, Week 36, Week 60)
- Change from baseline in scores in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)(Baseline, Week 36, Week 60)
- Change from baseline in scores in PGI-SPatient Global Impression of Severity（PGI-S）(Baseline, Week 36, Week 60)
- Mean Absolute Change from Baseline in Fasting Blood Insulin[mlU/L](Baseline, Week 36, Week 60)
- The proportion of subjects with at least a 25% improvement in liver stiffness measurement (LSM) relative to baseline based on FibroScan and FibroTouch measurements, and the proportion of subjects with at least a 30% improvement in controlled attenuation(Baseline, Week 36, Week 60)
研究者
研究点 (1)
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