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BMN 255 for Non-alcoholic Fatty Liver Disease

Verified Trial

Phase 1

Recruiting

Research Sponsored by BioMarin Pharmaceutical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of kidney stones (at least 1 stone prior to screening based on medical history); participants with a known personal or family history of cystinuria or cystine kidney stones, calcium phosphate stones, struvite stones, or urate stones should not be included

History of NAFLD with a liver fat content ≥ 8.0%, as determined by Fibroscan (transient elastography) or magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) during screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 7 of treatment periods 1 & 2, each treatment period is 7 days separated by a 7-9 day washout period and day 15

Awards & highlights

Study Summary

This trial tests the safety and effectiveness of BMN 255 for adults with NAFLD and hyperoxaluria, comparing it to a placebo.

Who is the study for?

This trial is for adults with Non-Alcoholic Fatty Liver Disease (NAFLD) and Hyperoxaluria, evidenced by high urine oxalate levels and a history of kidney stones. Participants must not have NASH or cirrhosis, inflammatory bowel disease, significant other medical conditions, or be on certain medications. They should have a liver fat content ≥ 8% confirmed by Fibroscan or MRI-PDFF.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of BMN 255 in reducing urine oxalate levels compared to a placebo. It involves daily oral doses of BMN 255 for participants with NAFLD and hyperoxaluria to see if it can improve their condition.See study design

What are the potential side effects?

While specific side effects are not listed here, the trial aims to assess the safety and tolerability of BMN 255. Potential side effects could range from mild digestive issues to more serious organ-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least one kidney stone but no family history of specific stone types.

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I have a fatty liver with at least 8% fat content confirmed by a scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 7 of treatment periods 1 & 2, each treatment period is 7 days separated by a 7-9 day washout period and day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 7 of treatment periods 1 & 2, each treatment period is 7 days separated by a 7-9 day washout period and day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 7 of treatment periods 1 & 2, each treatment period is 7 days separated by a 7-9 day washout period and day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary safety endpoint is the incidence of adverse events in adult participants with NAFLD and hyperoxaluria

Secondary outcome measures

To characterize the daily oral dose plasma pharmacokinetics of BMN 255 in adult participants with NAFLD and hyperoxaluria.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BMN 255 Investigational drug armExperimental Treatment1 Intervention

Oral administration of BMN 255 at a dose of 100mg per day for 7 days in Treatment Period 1 or 2

Group II: Placebo Comparative drug armPlacebo Group1 Intervention

Oral administration of Placebo at a dose of 100mg per day for 7 days in Treatment Period 1 or 2

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

BioMarin PharmaceuticalLead Sponsor

157 Previous Clinical Trials

189,987 Total Patients Enrolled

Medical Director, MDStudy DirectorBioMarin Pharmaceutical

77 Previous Clinical Trials

16,392 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for involvement in this investigation?

"The research study, launched on September 26th 2023 and updated on November 16th 2023, is actively searching for trial participants. This information can be found through clinicaltrials.gov"

Answered by AI

Does this clinical trial include individuals aged 45 and older?

"According to the standards set forth by this clinical trial, only those aged 18 or higher and younger than 70 may be eligible for participation."

Answered by AI

How many sites are currently executing this clinical trial?

"Currently, 6 medical centres have opened their doors to participants in this trial. These include ProSciento Inc., Georgia Clinical Research LLC., and Medpace's Clinical Pharmacology Unit as well as 3 other sites across the country."

Answered by AI

What possible risks are associated with using BMN 255 Investigational drug arm?

"There is only minimal information to support the efficacy and safety of BMN 255 Investigational drug arm, thus we have assigned it a rating of 1."

Answered by AI

What is the cap on participants for this clinical trial?

"Affirmative. Clinicaltrials.gov displays evidence that this experiment is presently enrolling participants after being first posted on September 26th 2023 and recently updated on November 16th 2023. The study requires 24 patients from 6 different research facilities."

Answered by AI

For what demographic is this trial best suited?

"In order to join this clinical trial, individuals must have hyperoxaluria and be between 18 and 70 years of age. The research team is looking for approximately two dozen participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06138327.

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