Akero 105 (Metabolic Dysfunction-Associated Steatohepatitis)_Dinani - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to find out if an experimental drug called efruxifermin (EFX) is a safe and effective option for people who have nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis (scarring of the liver tissue).

¿Cuál es la Condición que se está estudiando?

Metabolic Dysfunction-Associated Steatohepatitis (MASH) /Nonalcoholic Steatohepatitis (NASH)

¿Quién puede participar en el Estudio?

Adultos de 18 a 80 años que:

  • Are diagnosed with MASH/NASH
  • Have a diagnosis that is proven by biopsy
  • Have a history of Type 2 Diabetes

For more information, contact the study team at adele.gaskin@duke.edu.

Grupo etario
Adultos

¿Qué Implica?

If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 groups. Depending on your assignment, you will:

  • Get a 28mg dose of EFX; OR
  • Get a 50mg dose of EFX; OR
  • Get a placebo (inactive substance that has no drug in it)

You will take EFX or placebo for up to 96 weeks. Participation in the study will last for about 112 weeks. You will visit our clinic 24 times during the study, and the following procedures will be done over the course of the study: blood draws, liver biopsies, DXA scans, ultrasounds, and surveys.

Detalles del Estudio

Título Completo
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH NON-CIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH)/METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH) AND FIBROSIS
Investigador Principal
Amreen M. Dinani, MD, FRCPC
Especialista en hepatología
Número de Protocolo
IRB: PRO00115651
NCT: NCT06215716
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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