A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia

Inclusion Criteria:

• Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for PsychoticDisorders.

• CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline.

• PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF andat Baseline.

• Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset lessthan 60 days prior to signing the ICF.

• Willing to discontinue all prohibited medications to meet protocol-required washoutsprior to and during the trial period.

• Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs).

• Ability, in the opinion of the investigator, to understand the nature of the trial,participate in trial visits, and comply with protocol requirements.

Exclusion Criteria:

• Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondaryto schizophrenia are allowed); Acute depressive symptoms within 30 days prior tosigning the ICF that require treatment with an antidepressant are exclusory. Acutemanic symptoms within 30 days prior to signing the ICF that require treatment with amood stabilizer are exclusory.

• Any of the following:

• Schizophrenia considered resistant/refractory to antipsychotic treatment byhistory (failure to respond to 2 or more courses of adequate pharmacologicaltreatment defined as an adequate dose per label and a treatment duration of atleast 4 weeks)

• History of response to clozapine treatment only or failure to respond toclozapine treatment

• Any of the following regarding history of schizophrenia:

• Time from initial onset of schizophrenia <2 years based on prior records orparticipant self-report

• Presenting with an initial diagnosis of schizophrenia

• Presenting for the first time with an acute psychotic episode requiringtreatment

• Reduction (improvement) in PANSS total score of ≥20% between Screening and Baseline.

• Current or past history of significant cardiovascular, pulmonary, gastrointestinal,renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus),malignancy (except for basal cell carcinoma of the skin and cervical carcinoma insitu, at the discretion of the investigator), hematological, immunological,neurological, or psychiatric disease that, in the opinion of the investigator ormedical monitor, could compromise either participant safety or the results of thetrial.

• Active central nervous system infection, demyelinating disease, degenerativeneurological disease, brain tumor, prior hospitalization for severe head trauma,seizures (excluding febrile seizures in childhood), or any central nervous systemdisease deemed to be progressive during the course of the trial that may confoundthe interpretation of the trial results

• Diagnosis of moderate to severe substance or alcohol-use disorder (excludingnicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing theICF.

• Risk for suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and investigator's clinical assessment.

• Any condition that could possibly affect drug absorption.

• Use of prohibited medications prior to randomization within the required wash-outperiod or likely to require prohibited concomitant therapy during the trial.

• Clinically significant abnormal findings on the physical examination, medicalhistory review, ECG, or clinical laboratory results at screening.

• Positive pregnancy test result prior to receiving IMP. Note: female participants whoare pregnant, breastfeeding, or planning to become pregnant during IMP treatment orwithin 7 days after the last dose of IMP are also excluded.