A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of Dazucorilant, A Selective Glucocorticoid Receptor Modulator, in Amyotrophic Lateral Sclerosis

Summary

• DAZALS did not achieve its primary endpoint of slowing functional decline as measured by the ALSFRS-R scale
• Secondary and exploratory endpoints showed improvement in overall survival for participants who received dazucorilant 300 mg, especially in the subgroup treated for >24 weeks
• Dazucorilant-treated participants discontinued at higher rates than placebo-treated participants due to abdominal pain, which occurred in the first 3–5 weeks
  • Abdominal pain resolved following treatment interruption and with time in participants who continued treatment
• Abdominal pain was less frequent in participants titrated from dazucorilant 150 mg to 300 mg versus those escalated directly from placebo to 300 mg, suggesting improved tolerability with dose titration
• Dazucorilant-treated participants showed similar rates of serious and severe adverse events as the placebo group
• These findings support further evaluation of dazucorilant in a phase 3 study in people with ALS

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