Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07678775 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of BBP-418 (Ribitol) for LGMD2I/R9
A Phase 3 study, sponsored by ML Bio Solutions.
- Active
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
NCT07678775: Active Phase 3 study, sponsored by ML Bio Solutions.
NCT07678775 is a Phase 3 study that is active but no longer recruiting, run by ML Bio Solutions. The registered enrollment target is 107 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07678775, a Phase 3 study, is active but no longer recruiting, sponsored by ML Bio Solutions.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
Study Summary
This is an open-label extension (rollover) study designed to evaluate the long-term safety and efficacy of BBP-418 (ribitol) in participants with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) who have previously participated in Study MLB-01-005 (Fortify). Participants will receive BBP-418 administered orally at protocol-defined doses and schedules. The study will assess long-term safety through monitoring of adverse events, clinical laboratory evaluations, and other safety assessments. Efficacy will be evaluated using functional measures and other clinical endpoints relevant to LGMD2I/R9. Participants will be followed for up to 36 months, with a final safety follow-up assessment conducted approximately 30 days after the last dose of study drug.
Interventions
- DRUG BBP-418 (ribitol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2026-06-05 |
| Est. Completion | 2030-10 |
| Phase | Phase 3 |
What the registry record for NCT07678775 still lists
NCT07678775 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which BBP-418 (ribitol) is the first listed.
NCT07678775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07678775 about?
NCT07678775 is a clinical study titled "Open-Label Extension Study of BBP-418 (Ribitol) for LGMD2I/R9". This is an open-label extension (rollover) study designed to evaluate the long-term safety and efficacy of BBP-418 (ribitol) in participants with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) who have previously participated in Study MLB-01-005 (Fortify). Participants will receive BBP-418 a...
What is the current status of trial NCT07678775?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2026-06-05. Estimated completion is 2030-10.
What interventions are being tested in trial NCT07678775?
The interventions under investigation include: BBP-418 (ribitol) (DRUG).
Who is sponsoring clinical trial NCT07678775?
This trial is sponsored by ML Bio Solutions, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07678775's enrollment target sits among peer trials
107 1666th of 2000 higher than 335 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05491668 · 107 participants
Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI
- NCT06041594 · 107 participants · NA
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
- NCT06081426 · 107 participants · NA
Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
- NCT06527599 · 107 participants · NA
Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI