Trial Outcomes & Findings for Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia (NCT NCT06572449)
NCT ID: NCT06572449
Last Updated: 2026-06-22
Results Overview
Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
173 participants
Primary outcome timeframe
From first dose to end of study follow up (63 days)
Results posted on
2026-06-22
Participant Flow
100 participants treated in Cohort 1 and 73 Treated in Cohort 2
Participant milestones
| Measure |
Cohort 1
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Treatment Period
STARTED
|
100
|
73
|
|
Treatment Period
COMPLETED
|
83
|
56
|
|
Treatment Period
NOT COMPLETED
|
17
|
17
|
|
Follow Up
STARTED
|
100
|
73
|
|
Follow Up
COMPLETED
|
83
|
53
|
|
Follow Up
NOT COMPLETED
|
17
|
20
|
Reasons for withdrawal
| Measure |
Cohort 1
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Treatment Period
Requested to discontinue study treatment
|
14
|
11
|
|
Treatment Period
Adverse Event
|
1
|
6
|
|
Treatment Period
Other Reasons
|
1
|
0
|
|
Treatment Period
No longer meets study critieria
|
1
|
0
|
|
Follow Up
Withdrawal of consent by participant
|
13
|
16
|
|
Follow Up
Lost to Follow-up
|
2
|
3
|
|
Follow Up
Other Reasons
|
1
|
1
|
|
Follow Up
No Longer Meets Study Criteria
|
1
|
0
|
Baseline Characteristics
Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=20 Participants
|
73 Participants
n=20 Participants
|
173 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
47 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=20 Participants
|
53 Participants
n=20 Participants
|
126 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=20 Participants
|
57 Participants
n=20 Participants
|
139 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
75 Participants
n=20 Participants
|
53 Participants
n=20 Participants
|
128 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
42 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From first dose to end of study follow up (63 days)Population: All Treated Participants
Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Outcome measures
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Number of Participants With TEAEs From First Dose to End of Study Follow up.
TEAE
|
72 Participants
|
55 Participants
|
|
Number of Participants With TEAEs From First Dose to End of Study Follow up.
Treatment Related TEAEs
|
61 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: Period 1 (From first dose to day 28) Period 2 (day 29 to day 56)Population: All Treated Participants
Number of participants with TEAEs at the end of period 1 and period 2. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Outcome measures
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Number of Participants With TEAEs at the End of Period 1 and Period 2.
Period 1 (First dose to day 28)
|
62 Participants
|
49 Participants
|
|
Number of Participants With TEAEs at the End of Period 1 and Period 2.
Period 2 (from day 29 to day 56)
|
34 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)Population: All Treated Participants
Number of participants with TEAEs at the end of period 1 and period 2. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.
Period 1 (First dose to day 28)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.
Period 2 (from day 29 to day 56)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.
From First dose to day 63
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)Population: All Treated Participants
Number of participants with TEAEs leading to treatment discontinuation.
Outcome measures
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Number of Participants With TEAEs Leading to Treatment Discontinuation.
From First dose to day 63
|
1 Participants
|
5 Participants
|
|
Number of Participants With TEAEs Leading to Treatment Discontinuation.
Period 1 (First dose to day 28)
|
1 Participants
|
2 Participants
|
|
Number of Participants With TEAEs Leading to Treatment Discontinuation.
Period 2 (from day 29 to day 56)
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)Population: All Treated Participants
The number of participants experiencing adverse events related to procholinergic symptoms (believed to be associated with xanomeline) and anticholinergic symptoms (believed to be associated with trospium) symptoms. Examples of procholinergic symptoms include vomiting, nausea, diarrhea, sweating and hyper-salivation. Examples of anticholinergic include dizziness, confusion, hallucinations, and somnolence.
Outcome measures
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.
Period 2 Procholinergic
|
13 Participants
|
6 Participants
|
|
Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.
Period 1 Procholinergic
|
31 Participants
|
21 Participants
|
|
Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.
Period 1 Anticholinergic
|
34 Participants
|
27 Participants
|
|
Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.
Period 2 Anticholinergic
|
9 Participants
|
5 Participants
|
|
Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.
Overall Procholinergic
|
38 Participants
|
26 Participants
|
|
Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.
Overall Anticholinergic
|
41 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: From first dose to end of treatment (56 days)Population: All Treated Participants with measurement at end of treatment
The Positive and Negative Syndrome Scale (PANSS) assesses schizophrenia symptom severity using 30 items: 7 positive, 7 negative, and 16 general psychopathology scales. Each item is rated from 1 (absent) to 7 (extreme). Positive symptoms represent excesses or distortions of normal function (e.g., hallucinations, delusions), while negative symptoms reflect diminished function. The PANSS positive and negative scores each sum their respective 7 items, ranging from 7 to 49, with higher scores indicating greater severity. The PANSS Total Score sums all 30 items, ranging from 30 to 210, with higher scores reflecting worse overall symptom severity.
Outcome measures
| Measure |
Cohort 1
n=96 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=68 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Change From Baseline in PANSS Total Score, Positive Score and Negative Score
Total Score
|
-3.9 Score on a Scale
Standard Deviation 8.98
|
-2.7 Score on a Scale
Standard Deviation 7.40
|
|
Change From Baseline in PANSS Total Score, Positive Score and Negative Score
Positive Score
|
-1.7 Score on a Scale
Standard Deviation 3.37
|
-0.9 Score on a Scale
Standard Deviation 2.40
|
|
Change From Baseline in PANSS Total Score, Positive Score and Negative Score
Negative Score
|
-0.7 Score on a Scale
Standard Deviation 3.15
|
-0.9 Score on a Scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: From first dose to end of treatment (56 days)Population: All Treated Participants with measurement at end of treatment
PANSS Marder factor score is the sum of 5 negative scales and 2 general scales (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance). Participants are rated from 1 to 7 on each symptom scale, with a total score ranging from 7 to 49. Higher score indicates more severe symptoms. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Baseline is defined as the PANSS score at screening.
Outcome measures
| Measure |
Cohort 1
n=96 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=68 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Change From Baseline in Marder Factor Score.
|
-1.2 Score on a Scale
Standard Deviation 3.07
|
14.5 Score on a Scale
Standard Deviation 3.76
|
SECONDARY outcome
Timeframe: From first dose to end of treatment (56 days)Population: All Treated Participants with measurement at end of treatment
Completed independently by a clinician, the CGI-S categorizes the severity of the illness as: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients, by asking the clinical 1 question and providing a rating based upon observed and reported symptoms, behavior, and function in the past 7 days to reflect the average severity level across the 7 days. Higher score indicates more severe illness.
Outcome measures
| Measure |
Cohort 1
n=96 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=68 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Change From Baseline in CGI Severity Score
|
-0.2 Score on a Scale
Standard Deviation 0.66
|
-0.1 Score on a Scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: From first dose to end of study follow up (63 days)Population: All Treated Participants
The AEs of special interest (AESIs) will be monitored and include symptomatic orthostasis, syncope(a transient loss of consciousness or fainting),and liver function test elevations as defined below. For SAE reporting requirements for events of liver injury.
Outcome measures
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Number of Participants With Spontaneously Reported AESIs
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose to end of study follow up (63 days)Population: All Treated Participants
Number of participants with clinically significant changes in vital signs
Outcome measures
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose to end of study follow up (63 days)Population: All Treated Participants
Number of participants with clinically significant changes in clinical laboratory assessments
Outcome measures
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose to end of study follow up (63 days)Population: All Treated Participants
Number of participants with clinically significant changes in 12-lead ECGs
Outcome measures
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in 12-lead ECGs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose to end of study follow up (63 days)Population: All Treated Participants
Number of participants who exhibited suicidal behavior as assessed by C-SSRS
Outcome measures
| Measure |
Cohort 1
n=100 Participants
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 Participants
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Number of Participants Who Exhibited Suicidal Behavior as Assessed by C-SSRS
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=100 participants at risk
Period 1:
* Days 1-7 (Week 1)-KarXT 50/20 BID
* Days 8-14 (Week 2)-KarXT 100/20 BID
* Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID
Period 2:
* On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID
* During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
|
Cohort 2
n=73 participants at risk
Period 1:
* Days 1-7 (Week 1) -KarXT 50/20 BID
* Days 8-28(Week 2-Week 4) -KarXT 100/20 BID
Period 2:
* On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID
* Dose escalation will not be permitted during Period 2.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.0%
7/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
2/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
13.0%
13/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.4%
12/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
19.0%
19/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.9%
16/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.0%
7/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.0%
8/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
30.0%
30/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.3%
17/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
17/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.8%
13/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
7.0%
7/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.8%
5/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
13.0%
13/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.9%
16/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
1/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.5%
4/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
6/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
2/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
2/100 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.8%
5/73 • All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER