drugset / Trial / NCT06138327

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

NCT06138327 ↗

Phase 1 Withdrawn BioMarin Pharmaceutical
RandomizedCrossoverDouble-blindTreatment

Summary

The 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.

Timeline

Start
2023-09-26
Primary completion
2024-03-25
Completion
2024-03-25

Outcome

Outcome not reported

Stopped: “The study was withdrawn because BioMarin decided to end the overall development program. The study withdrawal was not due to any patient safety concerns.”

Drugs

EvaluationDrugModalityDoseRoute
Subject BMN 255 Unknown 100 mg Oral