Weight change, metabolic parameters, and prolactin^1,2

For schizophrenia in adults

Mean change in body weight from baseline was similar to placebo^1,2

In 4- to 6‑week clinical trials, at 4 weeks (+3.5 lbs for CAPLYTA 42 mg and +2.9 lbs for placebo)^1,2

In a 1‑year, open label safety trial with
CAPLYTA, patients saw an average
weight change of¹:

Minus 4 pounds after 6 months, minus 7 pounds after 1 year

Metabolic parameters in 4- to 6‑week trials and in a 1‑year, open‑label safety trial^1,2

Mean change from baseline in metabolic parameters^1,2

4- to 6-week trials

Open-label trial:
day 300

Proportion of patients (%)	CAPLYTA (n=406)	Placebo (n=412)	CAPLYTA
Glucose (mg/dL)	+0.7	+2.1	+3.0 (n=172)
Insulin (µIU/mL)			+1.0 (n=168)
Total cholesterol (mg/dL)	-3.0	-1.6	-9.6 (n=172)
LDL cholesterol (mg/dL)			-7.6 (n=167)
HDL cholesterol (mg/dL)			-1.4 (n=172)
Triglycerides (mg/dL)	-1.7	+4.6	-2.5 (n=172)

4- to 6-week trials

Proportion of patients (%)	CAPLYTA (n=406)	Placebo (n=412)
Glucose (mg/dL)	+0.7	+2.1
Insulin (µIU/mL)
Total cholesterol (mg/dL)	-3.0	-1.6
LDL cholesterol (mg/dL)
HDL cholesterol (mg/dL)
Triglycerides (mg/dL)	-1.7	+4.6

Open-label trial: day 300

Proportion of patients (%)	CAPLYTA
Glucose (mg/dL)	+3.0 (n=172)
Insulin (µIU/mL)	+1.0 (n=168)
Total cholesterol (mg/dL)	-9.6 (n=172)
LDL cholesterol (mg/dL)	-7.6 (n=167)
HDL cholesterol (mg/dL)	-1.4 (n=172)
Triglycerides (mg/dL)	-2.5 (n=172)

In 4- to 6‑week trials, metabolic parameters were similar to placebo¹

CAPLYTA mean change from baseline was similar to placebo in terms of glucose, total cholesterol, and triglycerides¹

LDL=low-density lipoprotein; HDL=high-density lipoprotein.

*n=number of subjects with data. Baseline is defined as last non-missing pretreatment measurement.

WARNINGS & PRECAUTIONS: Antipsychotic drugs have been reported to cause:

Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.

Please see additional Important Safety Information, including Boxed WARNINGS, below.

Study design

Short-term (4- to 6-week) data is from a placebo-controlled study of 811 patients with schizophrenia taking doses of CAPLYTA ranging from 14 to 84 mg/day.²

Long-term data is from an open-label study of 603 stable outpatients with schizophrenia who discontinued their current antipsychotic treatment and started CAPLYTA 42 mg with no dose titration. Assessment of safety, tolerability, and efficacy were conducted at baseline and were measured at Day 8, 15, 25, and approximately every 25 days thereafter, for up to 1 year.²

The primary objective was to evaluate the safety and tolerability of CAPLYTA.²

Full chart description

This graph depicts the mean change from baseline glucose levels, total cholesterol levels, and triglycerides levels over 4- to 6-weeks for patients receiving CAPLYTA 42 mg or placebo and at day 300 for patients receiving CAPLYTA 42 mg.

Over 4- to 6-weeks, patients on CAPLYTA saw a 0.7-point increase in glucose vs 2.1-point increase for those on placebo. Patients on CAPLYTA saw a 3.0-point reduction in total cholesterol vs 1.6-point reduction for those on placebo. Patients on CAPLYTA saw a 1.7-point reduction in triglycerides vs 4.6-point increase for those on placebo.

At day 300, patients on CAPLYTA saw a 3.0-point increase in glucose (n=172), a 1.0-point increase in insulin (n=168), a 9.6-point reduction in total cholesterol (n=172), a 7.6-point reduction in LDL cholesterol (n=167), a 1.4-point reduction in HDL cholesterol (n=172), and a 2.5-point reduction in triglycerides (n=172).

Changes in prolactin in 4- to 6‑week trials and in a 1‑year, open‑label safety trial²

Mean change from baseline in prolactin²

4- to 6-week trials

Open-label, monotherapy: day 300

Proportion of patients (%)	CAPLYTA (n=406)	Placebo (n=412)	CAPLYTA (n=171)
Prolactin (ng/mL)	-1.3	-0.2	-4.9

4- to 6-week trials

Proportion of patients (%)	CAPLYTA (n=406)	Placebo (n=412)
Prolactin (ng/mL)	-1.3	-0.2

Open-label, monotherapy: day 300

Open-label, monotherapy: day 300	CAPLYTA (n=171)
Prolactin (ng/mL)	-4.9

In 4- 6‑week trials, prolactin levels were similar to placebo¹

≥80% of patients on CAPLYTA remained normal in key metabolic parameters at Day 300^2†

Proportion of patients (%) whose key metabolic parameters shifted between normal, low, and high²

Baseline Normal

Proportion of patients (%)	Shifted Normal to Low	Remained Normal	Shifted Normal to High
Glucose (n=172)	<1% (1/151)	91% (138/151)	8% (12/151)
Insulin (n=168)	5% (7/134)	83% (111/134)	12% (16/134)
Total cholesterol (n=172)	12% (14/120)	80% (96/120)	8% (10/120)
LDL cholesterol (n=167)	3% (4/149)	93% (139/149)	4% (6/149)
Triglycerides (n=172)	4% (6/155)	92% (142/155)	4.5% (7/155)

Baseline Normal

Proportion of patients (%)	Shifted Normal to Low	Remained Normal	Shifted Normal to High
Glucose (n=172)	<1% (1/151)	91% (138/151)	8% (12/151)
Insulin (n=168)	5% (7/134)	83% (111/134)	12% (16/134)
Total cholesterol (n=172)	12% (14/120)	80% (96/120)	8% (10/120)
LDL cholesterol (n=167)	3% (4/149)	93% (139/149)	4% (6/149)
Triglycerides (n=172)	4% (6/155)	92% (142/155)	4.5% (7/155)

^†n=number of subjects with data. Baseline is defined as the last non-missing pretreatment measurement.²

WARNINGS & PRECAUTIONS: Antipsychotic drugs have been reported to cause:

Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.

Please see additional Important Safety Information, including Boxed WARNINGS, below.

CAPLYTA demonstrated safety in 2,664 adult patients
with schizophrenia and bipolar depression¹

Most Common
Adverse Reactions

Weight change, metabolic parameters, and prolactin1,2

For schizophrenia in adults

Mean change in body weight from baseline was similar to placebo1,2

In 4- to 6‑week clinical trials, at 4 weeks (+3.5 lbs for CAPLYTA 42 mg and +2.9 lbs for placebo)1,2

In a 1‑year, open label safety trial with CAPLYTA, patients saw an average weight change of1:

Metabolic parameters in 4- to 6‑week trials and in a 1‑year, open‑label safety trial1,2

Mean change from baseline in metabolic parameters1,2

4- to 6-week trials

Open-label trial: day 300

4- to 6-week trials

Open-label trial: day 300

View study design & full chart description

Changes in prolactin in 4- to 6‑week trials and in a 1‑year, open‑label safety trial2

Mean change from baseline in prolactin2

4- to 6-week trials

Open-label, monotherapy: day 300

4- to 6-week trials

Open-label, monotherapy: day 300

View full chart description

≥80% of patients on CAPLYTA remained normal in key metabolic parameters at Day 3002†

Proportion of patients (%) whose key metabolic parameters shifted between normal, low, and high2

Baseline Normal

Baseline Normal

Weight change, metabolic parameters, and prolactin^1,2

Mean change in body weight from baseline was similar to placebo^1,2

In 4- to 6‑week clinical trials, at 4 weeks (+3.5 lbs for CAPLYTA 42 mg and +2.9 lbs for placebo)^1,2

In a 1‑year, open label safety trial with
CAPLYTA, patients saw an average
weight change of¹:

Metabolic parameters in 4- to 6‑week trials and in a 1‑year, open‑label safety trial^1,2

Mean change from baseline in metabolic parameters^1,2

Open-label trial:
day 300

Changes in prolactin in 4- to 6‑week trials and in a 1‑year, open‑label safety trial²

Mean change from baseline in prolactin²

≥80% of patients on CAPLYTA remained normal in key metabolic parameters at Day 300^2†

Proportion of patients (%) whose key metabolic parameters shifted between normal, low, and high²