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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: A Phase 1b, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, 2-Period Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Oral Administration of

Brief 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.

Detailed Summary:
Sponsor: BioMarin Pharmaceutical

Current Primary Outcome: - Including but not limited to acute liver or kidney injury

Original Primary Outcome: - Including but not limited to acute liver or kidney injury

Current Secondary Outcome:

Original Secondary Outcome:

Information By: BioMarin Pharmaceutical

Dates:
Date Received: October 18, 2023
Date Started: September 26, 2023
Date Completion: September 26, 2023
Last Updated: November 16, 2023
Last Verified: November 01, 2023