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Recruiting NCT07209462

Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)

Conditions: Fragile X Syndrome

Sex: Male
Ages: 13 Years – 45 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: Mirum Pharmaceuticals, Inc.

Location: Southwest Autism Research & Resource Center Phoenix Arizona

Summary

This study is a multicenter, double-blind, randomized, placebo-controlled study to assess the safety and tolerability of 3 doses of MRM-3379 in male participants with Fragile X Syndrome ages 16 to 45 (inclusive). In addition, a parallel cohort of participants ages 13 to \

Eligibility Criteria

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 must provide assent if applicable. * Male, 13-45 years of age (inclusive) * Weight ≥30 kg and BMI between 18 and 36 kg/m2 (inclusive) at the screening visit * Diagnosis of FXS with a molecular genetic ≥200 CGG repetitions . * Able to perform the PVT and ORRT of the NIH-TCB * Have a consistent caregiver(s) who is willing and able to be present regularly and reliably with the participant * Able to swallow tablets or capsules Exclusion Criteria: History of or current medical condition other than FXS and related issues that would place the participant at higher risk from study participation

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07209462). StuddyBuddy aggregates publicly available trial information.