Asset profile
BI 1569912
Small molecule
Evidence outlook · lead readout
NCT06558344 · Depressive Disorder, Major
The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.
NCT06558344: The trial was randomized, double-blind, and placebo-controlled, with 225 participants assigned to placebo or one of three BI 1569912 doses. Its clinical primary endpoint, change in MADRS score at Week 6, was not statistically significant for any dose versus placebo, and the dose-response tests were also negative, supporting a moderate evidence grade rather than a strong one.
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