Calendario›BMRN›BMN 255

BMN 255

A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria

Ensayo de BIOMARIN PHARMACEUTICAL INC en Hyperoxaluria · Nonalcoholic Fatty Liver Disease · Kidney Stone (del registro, en inglés).

Fase

Fase 1

Estado

Retirado antes de empezar

Centros

7

Fin del objetivo primario

mar 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en sep 2023.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study was withdrawn because BioMarin decided to end the overall development program. The study withdrawal was not due to any patient safety concerns.».

Qué mide

The primary safety endpoint is the incidence of adverse events in adult participants with NAFLD and hyperoxaluria (Treatment Periods 1 & 2 through a 15 day follow-up after period 2. Each treatment period is 7 days separated by a 7-9 day washout period.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is to test the safety of BMN 255 and to learn about the effect BMN 255 has on you and your hyperoxaluria associated with NAFLD, and compare these effects with a placebo. The primary safety objective of the study is to assess the safety and tolerability of daily oral doses of BMN 255 in adult participants with NAFLD and hyperoxaluria. The primary efficacy objective of the study is to assess 24-hour urine oxalate levels (24-hour urine collection corrected for BSA) following daily oral doses of BMN 255 in adult participants with NAFLD and hyperoxaluria.

Más ensayos de BMRN

Todos los de BMRN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06138327), actualizada en jun 2024.