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NCT06138327
A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria
Phase 1 trial testing BMN 255 in Hyperoxaluria. Withdrawn.
25 March 2024
Quick facts
| Lead sponsor | BioMarin Pharmaceutical |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Start date | 26 September 2023 |
| Primary completion | 25 March 2024 |
| Estimated completion | 25 March 2024 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- BMN 255 — full drug profile →
- Placebo
Conditions studied
- Hyperoxaluria — all drugs for Hyperoxaluria →
- Nonalcoholic Fatty Liver Disease — all drugs for Nonalcoholic Fatty Liver Disease →
- Kidney Stone — all drugs for Kidney Stone →
Sponsor
BioMarin Pharmaceutical — full company profile →
Who can join
Adults 18 to 70, any sex, with Hyperoxaluria or Nonalcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Extracellular vesicle-mediated approaches for the diagnosis and therapy of MASLD: current advances and future prospective.
Gurjar S, Bhat A R, Upadhya R, Shenoy RP. · · 2025 · cited 10× · PMID 39773634 · DOI 10.1186/s12944-024-02396-3 -
MASLD development: From molecular pathogenesis toward therapeutic strategies.
Yang Z, Zhao J, Xie K, Tang C, et al · · 2025 · cited 6× · PMID 40640088 · DOI 10.1097/cm9.0000000000003629
Verify or expand the search:
- PubMed search for NCT06138327
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06138327 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BioMarin Pharmaceutical
- Last refreshed: 11 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06138327.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing