Adults 18 to 51, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Occurence of Treatment Emergent Adverse Events (TEAEs)Primary· From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Number of participants with treatment emergent adverse events.
Group
Value
95% CI
Iclepertin 10 mg
838
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT)Secondary· At baseline and at EOT. Up to a maximum of 60.1 weeks.
The change from baseline in the Clinical Global Impressions - Severity score (CGI-S) to end of treatment (EOT), calculated as \[CGI-S EOT\] - \[CGI-S baseline\] is reported. The CGI-S is composed of 1 question rated on a 4-point scale describing the severity of a patient's impairment, where 1 = none, 2 = mild, 3 = moderate, and 4 = severe.
Group
Value
95% CI
Iclepertin 10 mg
-0.13
± 0.57
Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT)Secondary· At baseline and at EOT. Up to a maximum of 60.1 weeks.
Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as \[last Hb on treatment\] - \[Hb baseline\], is reported.
Group
Value
95% CI
Iclepertin 10 mg
0.2
± 8.9
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term.
Participants take Iclepertin as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia.
Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team.
The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06070597 — A Study in Healthy People to Test Whether Iclepertin Has an Effect on Cardiac Safety
· Phase 1
· completed
NCT05731895 — A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems
· Phase 1
· completed
NCT04846868 — Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)
· Phase 3
· completed
NCT04846881 — Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)
· Phase 3
· completed
NCT04860830 — CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 8 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05211947.