2025-523675-39-00招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 173
- 试验地点
- 184
研究概览
简要总结
Week 52 Analysis: To determine the effect of efimosfermin compared to placebo on histologic resolution of MASH and improvement in fibrosis after 52 weeks treatment.
Month 48 Analysis To determine the time to a composite clinical outcome following treatment with efimosfermin compared to placebo after up to 48 months treatment.
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 that must be obtained prior to the initiation of study procedures.
- •Age >=18 and <=75 years at enrolment.
- •History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition.
- •Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score >=4 confirmed by a central pathologist
排除标准
- •Contraindication or ineligibility for percutaneous liver biopsy.
- •Glycated hemoglobin >=9.0%.
- •Model for End-Stage Liver Disease score >=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome).
- •Phosphatidyl ethanol (PEth) >=80 ng/mL at Screening.
- •Evidence of infection with any of the following: - Human immunodeficiency virus - Hepatitis B virus (detectable HBsAg at Screening) - 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 on screening liver biopsy; 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.
- •ALT or AST >=5*upper limit of normal (ULN).
- •Total bilirubin >=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total bilirubin of >=1.3 mg/dL and direct bilirubin is <=20% of total bilirubin; 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.
- •Alpha-fetoprotein >=20 nanogram per milliliter (ng/mL).
研究组 & 干预措施
Placebo for Efimosfermin alfa.
Placebo
干预措施: Placebo for Efimosfermin alfa. (Drug)
研究者
EU GSK Clinical Trials Call Center
Scientific
Glaxosmithkline Research & Development Limited
研究点 (184)
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