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GSK Zenith 2_Dinani - Clinical Trial

¿Cuál es el Propósito de este estudio?

If you can join this study, you will be placed by chance into one of three groups. One group will get 225 milligrams of the study medicine called GSK6519754, another group will get 300 milligrams, and the third group will get a placebo, which has no medicine. Most people will receive the study medicine. You will get the injection once every four weeks for several years. During the study, you will come to the clinic many times. At these visits, doctors will do blood tests, body and liver scans, ultrasounds, and ask you to fill out questionnaires to check your health and how the treatment is working.

¿Cuál es la Condición que se está estudiando?

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

¿Quién puede participar en el Estudio?

People may be able to join this study if they are between 18 and 75 years old. They must have, or may have, a liver disease called MASH. They also need to have at least two health conditions linked to metabolic syndrome, such as problems with blood sugar, cholesterol, blood pressure, or body weight.

Grupo etario
Adultos

¿Qué Implica?

This study is being done to learn if a new medicine called GSK6519754 can help people who have a liver disease called MASH. MASH happens when too much fat builds up in the liver and causes swelling and damage. Researchers want to see if this medicine can lower fat in the liver, reduce inflammation, and help the liver stay healthier.

Detalles del Estudio

Título Completo
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)
Investigador Principal
Amreen M. Dinani, MD, FRCPC
Especialista en hepatología
Número de Protocolo
IRB: PRO00120207
NCT: NCT07221188
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
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Contribuya a Duke Health