Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07209462 | Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM) | PHASE2 | RECRUITING | 60 | — | — | Nov 22, 2025 | Oct 1, 2027 | Jun 5, 2026 | 15 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm 1: Low Dose of MRM-3379 | EXPERIMENTAL | Participants 16-45 years of age randomized to this arm will receive the low dose of MRM-3379 |
| Arm 2: Middle dose of MRM-3379 | EXPERIMENTAL | Participants 16-45 years of age randomized to this arm will receive the middle dose of MRM-3379 |
| Arm 3: High dose of MRM-3379 | EXPERIMENTAL | Participants 16-45 years of age randomized to this arm will receive the high dose of MRM-3379 |
| Arm 4 :Placebo | PLACEBO_COMPARATOR | Participants 16-45 years of age randomized to this arm will receive Placebo |
| Arm 5: Low dose of MRM-3379 Open-Label | EXPERIMENTAL | Participants 13 to \< 16 years of age will receive the low dose of MRM-3370 Open-Label |
| Name | Type | Description |
|---|---|---|
| Low dose of MRM-3379 | DRUG | Oral capsule |
| Middle Dose of MRM-3379 | DRUG | Oral capsule |
| High dose of MRM-3379 | DRUG | Oral capsule |
| Placebo | DRUG | Capsules matched to study drug without the active pharmaceutical ingredient |
| Low dose of MRM-3379 Open-Label | DRUG | Oral capsule |
Inclusion Criteria: * Willing and able to provide signed informed consent/assent. Where local regulations permit inclusion of participants deemed unable to provide informed consent, a legally authorized representative must provide informed consent on the participant's behalf, and the participant mu...