A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in... | NCT05227703

Status Module

Label	Type	Description	Intervention Names
CVL-231 15 mg, once daily (QD)	Experimental	Oral Dose	Drug: Emraclidine 15 mg
CVL-231 30 mg, once daily (QD)	Experimental	Oral Dose	Drug: Emraclidine 30 mg
Placebo, once daily (QD)	Placebo Comparator	Oral Dose	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Emraclidine 15 mg	Drug	Emraclidine 15 mg, oral (tablet), once per day (QD) for 6 weeks	CVL-231 15 mg, once daily (QD)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score	The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.	Baseline through Week 6

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score)	The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate less mental illness.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders.
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 and at Baseline.
Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF.
Willing to discontinue all prohibited medications to meet protocol-required washouts prior 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 secondary to schizophrenia are allowed); Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory. Acute manic symptoms within 30 days prior to signing the ICF that require treatment with a mood stabilizer are exclusory.
Any of the following:
- Schizophrenia considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks)
- History of response to clozapine treatment only or failure to respond to clozapine treatment
Any of the following regarding history of schizophrenia:
- Time from initial onset of schizophrenia <2 years based on prior records or participant self-report
- Presenting with an initial diagnosis of schizophrenia
- Presenting for the first time with an acute psychotic episode requiring treatment
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 in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
Active central nervous system infection, demyelinating disease, degenerative neurological disease, brain tumor, prior hospitalization for severe head trauma, seizures (excluding febrile seizures in childhood), or any central nervous system disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results
Diagnosis of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the ICF.
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-out period or likely to require prohibited concomitant therapy during the trial.
Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening.
Positive pregnancy test result prior to receiving IMP. Note: female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP are also excluded.

Name	Affiliation	Role
Julie Adams	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Bentonville, Arkansas		Bentonville	Arkansas	72712-3873	United States
Bellflower, California

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received a single daily oral dose of Placebo each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
FG001	Emraclidine 15 mg QD

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 15, 2023	Aug 14, 2025

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received a single daily oral dose of Placebo each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
BG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
BG002	Emraclidine 30 mg QD	Participants received a single daily oral dose of Emraclidine 30 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score

The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

Modified Intent-to-Treat population (mITT): All randomized participants who receive at least 1 dose of investigational medicinal product (IMP) and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with a non-missing value.

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Baseline through Week 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG002	Emraclidine 30mg QD	Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Units	Counts
Participants	OG000104 OG00194 OG00296

Title

Denominators

Categories

Title	Measurements
	OG000-16.1(-19.4 to -12.8) OG001-18.5(-22.0 to -15.0) OG002-14.2(-17.5 to -10.8)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Model for Repeated Measures (MMRM)		0.2925	Emraclidine 15 mg versus Placebo	LS Mean Difference	-2.4	Standard Error of the Mean	2.30	2-Sided	95	-7.0	2.1			Emraclidine 15 mg - Placebo		Superiority	Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.

Secondary

Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score)

The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate less mental illness.

mITT: All randomized participants who receive at least 1 dose of investigational medicinal product (IMP) and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with available data.

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Baseline through Week 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Secondary

Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Baseline; Weeks 1, 2, 3, 4, 5, and 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Secondary

Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score

The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Baseline was defined as the last value obtained prior to initiation of Emraclidine. Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate less mental illness.

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Baseline; Weeks 1, 2, 3, 4, 5, and 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Secondary

Percentage of Responders at Week 6 (Responders Defined as ≥30% Reduction From Baseline in PANSS Total Score)

The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 6 or the early termination visit. If a subject discontinued and did not have an early termination visit, the subject's last assessment was considered.

mITT: All randomized participants who receive at least 1 dose of Emraclidine and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with a non-missing value.

Posted

Number

percentage of participants

Baseline through Week 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Secondary

Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP).

Posted

Count of Participants

Participants

From first dose of study drug until 28 days following last dose of study drug (up to Week 10)

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001

Secondary

Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)

Assessment of clinically significant changes in electrocardiogram measures measured by 12-lead ECG recording after the participant has been supine and at rest for at least 3 minutes.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

Baseline; from first dose of study drug up to Week 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG002	Emraclidine 30 mg QD	Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Secondary

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

Baseline; from first dose of study drug up to Week 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG002	Emraclidine 30 mg QD	Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Secondary

Number of Participants With Clinically Significant Changes in Vital Sign Measurements

Vital signs were obtained after the participant had been supine and at rest for 3 minutes and included temperature, systolic and diastolic blood pressure, respiratory rate, and heart rate. Participants' body weights were also measured and recorded.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

Baseline; from first dose of study drug up to Week 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG002	Emraclidine 30 mg QD	Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Secondary

Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results

The number of participants with clinically significant changes in physical and neurological examination results was documented.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

Baseline; from first dose of study drug up to Week 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG002	Emraclidine 30 mg QD	Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Secondary

Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)

The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)

Posted

Count of Participants

Participants

Baseline; from first dose of study drug up to Week 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG002	Emraclidine 30 mg QD

Secondary

Change From Baseline in Simpson Angus Scale (SAS) Total Score

The SAS consists of a list of 10 symptoms of parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items. Baseline was defined as the last value obtained prior to initiation of study drug. Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate an improvement in symptoms.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Baseline; Weeks 3 and 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Secondary

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Rating Score

The Abnormal Involuntary Movement Scale assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1-4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the participant is at rest, and the investigator also makes global judgments on the participant's dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the participant's dental status. The AIMS Movement Rating Score is defined as the sum of individual scores from items 1-7, ranging from 0 to 28. A lower score indicates less severe or absent abnormal movements. A negative change in the mean from baseline indicates improvement in the severity of abnormal involuntary movements.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Baseline; Weeks 3 and 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001

Secondary

Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Evaluation Score

The BARS consists of 4 items related to akathisia: The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The fourth item, reported here, is the Global Clinical Evaluation Score. The Global Clinical Evaluation Score is evaluated using a 6-point scale, with a score of 0 representing the absence of symptoms and a score of 5 representing severe akathisia. A negative change from baseline indicates an improvement in symptoms.

Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data.

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Baseline; Weeks 3 and 6

ID	Title	Description
OG000	Placebo	Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.
OG001	Emraclidine 15 mg QD	Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received a single daily oral dose of Placebo each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.	130	1	130	47	130
EG001	Emraclidine 15mg QD	Participants received a single daily oral dose of Emraclidine 15 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.	130	3	130	47	130
EG002	Emraclidine 30mg QD	Participants received a single daily oral dose of Emraclidine 30 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.	131	1	131	50	131

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
VISION BLURRED	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0011 events1 affected130 at risk EG0020 events0 affected131 at risk
HEADACHE	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0011 events1 affected130 at risk EG0020 events0 affected131 at risk
NEUROLEPTIC MALIGNANT SYNDROME	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected130 at risk EG0010 events0 affected130 at risk EG0020 events0 affected131 at risk
ACUTE PSYCHOSIS	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0011 events1 affected130 at risk EG0020 events0 affected131 at risk
AGITATION	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0010 events0 affected130 at risk EG0021 events1 affected131 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0011 events1 affected130 at risk EG0020 events0 affected131 at risk
SCHIZOPHRENIA	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0011 events1 affected130 at risk EG0020 events0 affected131 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
SINUS TACHYCARDIA	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0015 events4 affected130 at risk EG0020 events0 affected131 at risk
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0004 events3 affected130 at risk EG0014 events4 affected130 at risk EG0020 events0 affected131 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0002 events2 affected130 at risk EG0016 events6 affected130 at risk EG0023 events3 affected131 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected130 at risk EG0011 events1 affected130 at risk EG0027 events7 affected131 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0002 events2 affected130 at risk EG0014 events4 affected130 at risk EG0023 events3 affected131 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0011 events1 affected130 at risk EG0023 events3 affected131 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0005 events5 affected130 at risk EG0016 events6 affected130 at risk EG0024 events4 affected131 at risk
TOOTHACHE	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0006 events6 affected130 at risk EG0013 events3 affected130 at risk EG0022 events2 affected131 at risk
TINEA PEDIS	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0010 events0 affected130 at risk EG0023 events3 affected131 at risk
TOOTH ABSCESS	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0002 events2 affected130 at risk EG0010 events0 affected130 at risk EG0023 events3 affected131 at risk
BLOOD PRESSURE INCREASED	Investigations	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0013 events3 affected130 at risk EG0021 events1 affected131 at risk
WEIGHT INCREASED	Investigations	MedDRA (27.0)	Systematic Assessment	EG0005 events5 affected130 at risk EG00111 events11 affected130 at risk EG0024 events4 affected131 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0003 events3 affected130 at risk EG0010 events0 affected130 at risk EG0023 events3 affected131 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0013 events3 affected130 at risk EG0021 events1 affected131 at risk
DIZZINESS	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0013 events2 affected130 at risk EG0023 events3 affected131 at risk
HEADACHE	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG00017 events14 affected130 at risk EG00119 events18 affected130 at risk EG00219 events17 affected131 at risk
SOMNOLENCE	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0006 events6 affected130 at risk EG0014 events4 affected130 at risk EG0024 events4 affected131 at risk
ANXIETY	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0004 events4 affected130 at risk EG0014 events4 affected130 at risk EG0024 events4 affected131 at risk
INSOMNIA	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0004 events4 affected130 at risk EG0012 events2 affected130 at risk EG0024 events4 affected131 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0003 events3 affected130 at risk EG0010 events0 affected130 at risk EG0023 events3 affected131 at risk

ID	Term
D012559	Schizophrenia
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders