Status:
RECRUITING
Study of MRM-3379 in Male Participants With Fragile X Syndrome
Lead Sponsor:
Mirum Pharmaceuticals, Inc.
Conditions:
Fragile X Syndrome
Eligibility:
MALE
13-45 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- History of or current medical condition other than FXS and related issues that would place the participant at higher risk from study participation
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07209462
Start Date
December 1 2025
End Date
October 1 2027
Last Update
November 26 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Amnova Clinical Research, LLC
Irvine, California, United States, 92604
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 42229
4
Suburban Research Associates
Media, Pennsylvania, United States, 19063