Trial Outcomes & Findings for A Study to Test Different Doses of BI 1569912 in People With Depression (NCT NCT06558344)

Last Updated: 2026-05-22

Results Overview

The change from baseline at Week 6 in the total Montgomery-Åsberg Depression Rating Scale (MADRS) score is reported, calculated as \[Week 6 MADRS score\] - \[Baseline MADRS score\]. The MADRS score assessed the severity of symptoms in people with depression, consisting of 10 items. Each item was rated from 0 (no symptom) to 6 (severe symptom), with a total score ranging from 0 to 60 (0 = normal/absence of symptoms, 60 = severe depression). The least squares mean and 95% confidence intervals were estimated by a mixed model for repeated measures (MMRM) including the fixed categorical effects of treatment at each time point and the number of antidepressant treatments taken for the current episode (0/1), and the baseline MADRS total score at each time point as fixed continuous effects. The time point is treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

225 participants

Primary outcome timeframe

MMRM included measurements at baseline, Day 8, Week 2, Week 4, and Week 6. Change from baseline values at Week 6 is reported.

Results posted on

2026-05-22

Participant Flow

Phase II dose finding multicentre, randomised, double-blind, placebo-controlled trial to examine the efficacy and safety of different doses of oral BI 1569912 once daily over a planned 6-week treatment period in adult patients with moderate to severe major depressive disorder (MDD). Participants were randomized to placebo or one of 3 doses of active BI 1569912 (5, 10, or 20 mg) in a 2:1:1:2 ratio.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Placebo-matching BI 1569912 Patients with moderate to severe major depressive disorder (MDD) took placebo matching in size and weight to BI 1569912 tablets orally, once daily.	5 mg BI 1569912 Patients with moderate to severe major depressive disorder (MDD) took two 2.5 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 5 mg.	10 mg BI 1569912 Patients with moderate to severe major depressive disorder (MDD) took one 10 milligrams (mg) tablet of BI 1569912 and one placebo tablet orally, once daily, for a total dose of 10 mg.	20 mg BI 1569912 Patients with moderate to severe major depressive disorder (MDD) took two 10 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 20 mg.
Overall Study STARTED	76	35	41	73
Overall Study COMPLETED	63	29	35	66
Overall Study NOT COMPLETED	13	6	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo-matching BI 1569912 Patients with moderate to severe major depressive disorder (MDD) took placebo matching in size and weight to BI 1569912 tablets orally, once daily.	5 mg BI 1569912 Patients with moderate to severe major depressive disorder (MDD) took two 2.5 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 5 mg.	10 mg BI 1569912 Patients with moderate to severe major depressive disorder (MDD) took one 10 milligrams (mg) tablet of BI 1569912 and one placebo tablet orally, once daily, for a total dose of 10 mg.	20 mg BI 1569912 Patients with moderate to severe major depressive disorder (MDD) took two 10 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 20 mg.
Overall Study No reason available	2	4	0	1
Overall Study Other reason than listed	5	1	1	3
Overall Study Protocol deviation	2	0	1	1
Overall Study Burden of study procedures	1	0	2	0
Overall Study Change of residence	0	1	0	0
Overall Study Perceived lack of efficacy	1	0	0	0
Overall Study Adverse Event	2	0	2	2

Baseline Characteristics

Primary analysis set (PAS) - all randomized participants who received at least one dose of study drug during the trial and had a baseline MADRS total score ≥24.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo-matching BI 1569912 n=76 Participants Patients with moderate to severe major depressive disorder (MDD) took placebo matching in size and weight to BI 1569912 tablets orally, once daily.	5 mg BI 1569912 n=35 Participants Patients with moderate to severe major depressive disorder (MDD) took two 2.5 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 5 mg.	10 mg BI 1569912 n=41 Participants Patients with moderate to severe major depressive disorder (MDD) took one 10 milligrams (mg) tablet of BI 1569912 and one placebo tablet orally, once daily, for a total dose of 10 mg.	20 mg BI 1569912 n=73 Participants Patients with moderate to severe major depressive disorder (MDD) took two 10 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 20 mg.	Total n=225 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=76 Participants	6 Participants n=35 Participants	11 Participants n=41 Participants	19 Participants n=73 Participants	48 Participants n=225 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=76 Participants	29 Participants n=35 Participants	30 Participants n=41 Participants	54 Participants n=73 Participants	177 Participants n=225 Participants
Age, Continuous	41.2 Years STANDARD_DEVIATION 14.3 • n=76 Participants	39.9 Years STANDARD_DEVIATION 11.1 • n=35 Participants	43.8 Years STANDARD_DEVIATION 14.6 • n=41 Participants	40.8 Years STANDARD_DEVIATION 13.0 • n=73 Participants	41.4 Years STANDARD_DEVIATION 13.4 • n=225 Participants
Sex: Female, Male Female	43 Participants n=76 Participants	21 Participants n=35 Participants	22 Participants n=41 Participants	36 Participants n=73 Participants	122 Participants n=225 Participants
Sex: Female, Male Male	33 Participants n=76 Participants	14 Participants n=35 Participants	19 Participants n=41 Participants	37 Participants n=73 Participants	103 Participants n=225 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=76 Participants	0 Participants n=35 Participants	0 Participants n=41 Participants	0 Participants n=73 Participants	0 Participants n=225 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=76 Participants	0 Participants n=35 Participants	1 Participants n=41 Participants	1 Participants n=73 Participants	2 Participants n=225 Participants
Race (NIH/OMB) Asian	17 Participants n=76 Participants	3 Participants n=35 Participants	8 Participants n=41 Participants	12 Participants n=73 Participants	40 Participants n=225 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=76 Participants	0 Participants n=35 Participants	0 Participants n=41 Participants	0 Participants n=73 Participants	0 Participants n=225 Participants
Race (NIH/OMB) Black or African American	14 Participants n=76 Participants	12 Participants n=35 Participants	13 Participants n=41 Participants	23 Participants n=73 Participants	62 Participants n=225 Participants
Race (NIH/OMB) White	40 Participants n=76 Participants	17 Participants n=35 Participants	14 Participants n=41 Participants	33 Participants n=73 Participants	104 Participants n=225 Participants
Race (NIH/OMB) More than one race	4 Participants n=76 Participants	2 Participants n=35 Participants	2 Participants n=41 Participants	2 Participants n=73 Participants	10 Participants n=225 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=76 Participants	1 Participants n=35 Participants	3 Participants n=41 Participants	2 Participants n=73 Participants	7 Participants n=225 Participants
Total Montgomery-Åsberg Depression Rating Scale (MADRS) score	31.6 Units on a scale STANDARD_DEVIATION 4.7 • n=72 Participants • Primary analysis set (PAS) - all randomized participants who received at least one dose of study drug during the trial and had a baseline MADRS total score ≥24.	32.0 Units on a scale STANDARD_DEVIATION 4.1 • n=33 Participants • Primary analysis set (PAS) - all randomized participants who received at least one dose of study drug during the trial and had a baseline MADRS total score ≥24.	32.2 Units on a scale STANDARD_DEVIATION 4.5 • n=36 Participants • Primary analysis set (PAS) - all randomized participants who received at least one dose of study drug during the trial and had a baseline MADRS total score ≥24.	32.2 Units on a scale STANDARD_DEVIATION 4.2 • n=67 Participants • Primary analysis set (PAS) - all randomized participants who received at least one dose of study drug during the trial and had a baseline MADRS total score ≥24.	31.9 Units on a scale STANDARD_DEVIATION 4.4 • n=208 Participants • Primary analysis set (PAS) - all randomized participants who received at least one dose of study drug during the trial and had a baseline MADRS total score ≥24.

PRIMARY outcome

Timeframe: MMRM included measurements at baseline, Day 8, Week 2, Week 4, and Week 6. Change from baseline values at Week 6 is reported.

Population: Primary analysis set (PAS) - all randomized participants who received at least one dose of study drug during the trial and had a baseline MADRS total score ≥24. Only participants with a baseline and at least one post-baseline MADRS value were included in the analysis.

Outcome measures

Outcome measures
Measure	Placebo-matching BI 1569912 n=70 Participants Patients with moderate to severe major depressive disorder (MDD) took placebo matching in size and weight to BI 1569912 tablets orally, once daily.	5 mg BI 1569912 n=30 Participants Patients with moderate to severe major depressive disorder (MDD) took two 2.5 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 5 mg.	10 mg BI 1569912 n=36 Participants Patients with moderate to severe major depressive disorder (MDD) took one 10 milligrams (mg) tablet of BI 1569912 and one placebo tablet orally, once daily, for a total dose of 10 mg.	20 mg BI 1569912 n=66 Participants Patients with moderate to severe major depressive disorder (MDD) took two 10 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 20 mg.
Change From Baseline in MADRS Total Score at Week 6	-10.3 Units on a scale Interval -13.1 to -7.5	-13.6 Units on a scale Interval -17.8 to -9.4	-10.6 Units on a scale Interval -14.5 to -6.7	-10.0 Units on a scale Interval -12.9 to -7.2

Adverse Events

Placebo-matching BI 1569912

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

5 mg BI 1569912

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

10 mg BI 1569912

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

20 mg BI 1569912

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo-matching BI 1569912 n=76 participants at risk Patients with moderate to severe major depressive disorder (MDD) took placebo matching in size and weight to BI 1569912 tablets orally, once daily.	5 mg BI 1569912 n=35 participants at risk Patients with moderate to severe major depressive disorder (MDD) took two 2.5 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 5 mg.	10 mg BI 1569912 n=41 participants at risk Patients with moderate to severe major depressive disorder (MDD) took one 10 milligrams (mg) tablet of BI 1569912 and one placebo tablet orally, once daily, for a total dose of 10 mg.	20 mg BI 1569912 n=73 participants at risk Patients with moderate to severe major depressive disorder (MDD) took two 10 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 20 mg.
Cardiac disorders Acute left ventricular failure	0.00% 0/76 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	0.00% 0/35 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	2.4% 1/41 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	0.00% 0/73 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.
Psychiatric disorders Suicidal ideation	1.3% 1/76 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	0.00% 0/35 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	0.00% 0/41 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	0.00% 0/73 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/76 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	0.00% 0/35 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	2.4% 1/41 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	0.00% 0/73 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.

Other adverse events

Other adverse events
Measure	Placebo-matching BI 1569912 n=76 participants at risk Patients with moderate to severe major depressive disorder (MDD) took placebo matching in size and weight to BI 1569912 tablets orally, once daily.	5 mg BI 1569912 n=35 participants at risk Patients with moderate to severe major depressive disorder (MDD) took two 2.5 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 5 mg.	10 mg BI 1569912 n=41 participants at risk Patients with moderate to severe major depressive disorder (MDD) took one 10 milligrams (mg) tablet of BI 1569912 and one placebo tablet orally, once daily, for a total dose of 10 mg.	20 mg BI 1569912 n=73 participants at risk Patients with moderate to severe major depressive disorder (MDD) took two 10 milligrams (mg) tablets of BI 1569912 orally, once daily, for a total dose of 20 mg.
Gastrointestinal disorders Diarrhoea	1.3% 1/76 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	5.7% 2/35 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	4.9% 2/41 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	2.7% 2/73 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.
Infections and infestations Influenza	6.6% 5/76 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	0.00% 0/35 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	2.4% 1/41 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	1.4% 1/73 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.
Infections and infestations Nasopharyngitis	3.9% 3/76 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	2.9% 1/35 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	4.9% 2/41 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	8.2% 6/73 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.
Infections and infestations Upper respiratory tract infection	1.3% 1/76 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	5.7% 2/35 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	0.00% 0/41 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	1.4% 1/73 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.
Nervous system disorders Headache	7.9% 6/76 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	14.3% 5/35 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	9.8% 4/41 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.	12.3% 9/73 • All-cause mortality and adverse event reporting: From first drug administration to last drug administration for each of the interventions, plus residual effect period. Up to 81 days. Treated set: All participants who were randomized and treated with the study drug.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER