A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults With Alcohol-related Liver Disease (ALD)

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06613698Tipo: INTERVENTIONALInicio: 27 de sept de 2024Fin estimado: 30 de mar de 2028

Gastroenterología Enfermedades Infecciosas

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Resumen

The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

A female participant is eligible to participate after meeting additional pre-defined criteria.
Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
Capable of giving signed informed consent prior to the performance of any study-specific procedures.
Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD.

Criterios de exclusión

Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)
Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets, International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria.
Current malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible.
Prior organ transplant or current listing or active consideration for organ transplant during the screening period (except for corneal transplants).
Chronic or acute, including partial, known portal vein thrombosis.
Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.
Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening.
Poorly controlled hypertension
Clinical suspicion of rhabdomyolysis during the screening period
Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and/or low blood fibrinogen level.
Body Mass Index (BMI) \>35 kg/m2 at screening
Any liver-related clinical event that started (onset) \<8 weeks prior to Baseline (D1).

Intervenciones

drug

GSK4532990

GSK4532990 will be administered

drug

Placebo

Placebo will be administered

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Ciudad AutOnoma de Buenos Aire, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Rosario, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

San Miguel de Tucumán, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

Patrocinadores

PrincipalGlaxoSmithKline

Contactos

US GSK Clinical Trials Call Center

CONTACT

GSKClinicalSupportHD@gsk.com 877-379-3718

EU GSK Clinical Trials Call Center

CONTACT

GSKClinicalSupportHD@gsk.com +44 (0) 20 89904466

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