2025-523674-16-00招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 163
- 主要终点
- For all participants at Week 52, incidence and severity of TEAEs.
研究概览
简要总结
To assess the effects of efimosfermin on safety and tolerability.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
- •Age >=18 through <=75 years at enrolment
- •History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
- •History or presence of known or suspected MASH
排除标准
- •ALT or AST >=5 × upper limit of normal (ULN)
- •Phosphatidylethanol (PEth) >=80 nanogram per milliliter (ng/mL) at Screening
- •Evidence of infection with any of the following: a. Human immunodeficiency virus; b. Hepatitis B virus (detectable HBsAg at Screening); c. Hepatitis C virus (HCV)
- •Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis, or any history or evidence of cirrhosis; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day
- •Current or history of excessive alcohol intake for >=3 months within the 12-month period prior to Screening
- •Total bilirubin (BILI) >=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of >=1.3 mg/dL and direct BILI is <=20% of total BILI; otherwise, the individual will be excluded.
- •Serum albumin <=3.5 grams per deciliter (g/dL)
- •International normalized ratio (INR) >=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.
- •Alkaline phosphatase (ALP) >=2 × ULN
- •Platelet (PLT) count <140 000 per (/) cubic millimeter (mm^3); individuals with a PLT count between 110,000/mm^3 and 140,000/mm^3 may be enrolled after discussion with the Study Medical Monitor
- •Serum creatinine >=1.5 mg/dL or creatinine clearance <=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation.
- •HbA1c >=9.0%
- •Model for End-Stage Liver Disease (MELD) 3.0 score >=12 unless the score is elevated in the absence of liver dysfunction (eg, Gilbert's syndrome)
研究组 & 干预措施
Placebo for Efimosfermin alfa
Placebo
干预措施: Placebo for Efimosfermin alfa (Drug)
结局指标
主要结局
For all participants at Week 52, incidence and severity of TEAEs.
For all participants at Week 52, incidence and severity of TEAEs.
For all participants at Week 52, incidence and severity of TEAEs leading to discontinuation.
For all participants at Week 52, incidence and severity of TEAEs leading to discontinuation.
For all participants at Week 52, incidence of Grade 3 and Grade 4 laboratory abnormalities.
For all participants at Week 52, incidence of Grade 3 and Grade 4 laboratory abnormalities.
次要结局
- Incidence of ADAs at Week 52.
- Efimosfermin serum concentrations in participants with PK data following multiple doses.
- Absolute and relative change from baseline to Week 52 in ELF score for all participants.
- Achieving an improvement in ELF score of ≥ 0.5.
- Absolute and relative change from baseline to Week 52 in VCTE-LSM scores for all participants.
- Achieving a change from baseline in VCTE-LSM ≥ 30% at Week 52.
- Absolute and relative change from baseline to Week 52 in the subset of participants with MRE scores.
- Absolute and relative change from baseline to Week 52 in HFF by MRI-PDFF for all participants.
- Absolute and relative change from baseline to Week 52 in ALT, AST, and ALT/AST ratio for all participants.
- Achieving ALT and HFF normalization at Week 52.
- Achieving HFF ≤ 5% at Week 52.
- Change from baseline to Week 52 in HbA1c for participants with T2DM.
- Change from baseline to Week 52 in body weight for all participants.
- Change from baseline in fasting total cholesterol, LDL-C, HDL-C, and fasting triglycerides at Week 52 for all participants.
研究者
EU GSK Clinical Trials Call Center
Scientific
Glaxosmithkline Research & Development Limited
研究点 (163)
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