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

Conditions

• Fragile X Syndrome

Eligibility Criteria

Sex

MALE

Age

13 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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 \<16 will receive open-label MRM-3379. All participants will participate for 12 weeks of treatment. The study is also intended as a proof-of-concept investigation to evaluate whether MRM-3379 can improve FXS symptoms

Key Dates

Start date

Nov 22, 2025

Status verified

Jun 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Low Dose of MRM-3379
  Participants 16-45 years of age randomized to this arm will receive the low dose of MRM-3379
• Experimental: Arm 2: Middle dose of MRM-3379
  Participants 16-45 years of age randomized to this arm will receive the middle dose of MRM-3379
• Experimental: Arm 3: High dose of MRM-3379
  Participants 16-45 years of age randomized to this arm will receive the high dose of MRM-3379
• Placebo Comparator: Arm 4 :Placebo
  Participants 16-45 years of age randomized to this arm will receive Placebo
• Experimental: Arm 5: Low dose of MRM-3379 Open-Label
  Participants 13 to \< 16 years of age will receive the low dose of MRM-3370 Open-Label

Primary Outcome Measure

Incidence and severity of treatment-emergent adverse events and Withdrawal due to adverse events and withdrawal due to adverse events [ Time Frame: Baseline to Week 12 ]

Locations (15)

Find similar trials in Phoenix, AZ

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