Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years (NCT NCT03338296)

NCT ID: NCT03338296

Last Updated: 2021-07-19

Results Overview

BMI is a participant's weight in kilograms divided by the square of height in meters. Change from baseline was calculated as the post-baseline value minus the baseline value.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 278 participants
• Primary outcome timeframe: Baseline up to Week 52
• Results posted on: 2021-07-19

Participant Flow

Participants took part in the study at 18 investigative sites in the United States from 28 September 2017 to 03 April 2020.

A total of 359 participants were screened, of which 81 participants were screen failures and 278 participants were randomized and treated in the study.

Participant milestones

Measure	Placebo Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg Participants received one lorcaserin 20 milligram (mg) tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Overall Study STARTED	139	139
Overall Study Safety Analysis Set	139	136
Overall Study COMPLETED	36	31
Overall Study NOT COMPLETED	103	108

Reasons for withdrawal

Measure	Placebo Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg Participants received one lorcaserin 20 milligram (mg) tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	14	13
Overall Study Lost to Follow-up	10	10
Overall Study Study Terminated by Sponsor	77	76
Overall Study Other	2	7
Overall Study Missing	0	1

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years

Baseline characteristics by cohort

Measure	Placebo n=139 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=136 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.	Total n=275 Participants Total of all reporting groups
Age, Continuous	14.2 years STANDARD_DEVIATION 1.58 • n=5 Participants	14.1 years STANDARD_DEVIATION 1.59 • n=7 Participants	14.2 years STANDARD_DEVIATION 1.58 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants	81 Participants n=7 Participants	166 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	59 Participants n=5 Participants	44 Participants n=7 Participants	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants	92 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants	92 Participants n=7 Participants	188 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 52

Population: The full analysis set was the group of all randomized participants regardless of adherence to study drug. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

BMI is a participant's weight in kilograms divided by the square of height in meters. Change from baseline was calculated as the post-baseline value minus the baseline value.

Outcome measures

Measure	Placebo n=37 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=30 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Body Mass Index (BMI) From Baseline up to Week 52	0.71 kilogram per square meter (kg/m^2) Standard Deviation 2.317	0.50 kilogram per square meter (kg/m^2) Standard Deviation 1.882

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Outcome measures

Measure	Placebo n=139 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=136 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Percentage of Participants Who Achieved at Least a 5 Percent (%) BMI Reduction at Week 52	18.9 percentage of participants	13.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Outcome measures

Measure	Placebo n=139 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=136 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Percentage of Participants Who Achieved at Least a 5% BMI Reduction at Week 12	15.6 percentage of participants	18.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Outcome measures

Measure	Placebo n=139 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=136 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Percentage of Participants Who Achieved at Least a 10% BMI Reduction at Week 52	2.7 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo n=37 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=30 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Percent Change in BMI From Baseline up to Week 52	2.26 percent change Standard Deviation 6.633	1.57 percent change Standard Deviation 5.398

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo n=7 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=6 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in BMI From Baseline up to Week 52 in Participants Who Also Had the Outcome of Achieving at Least a 5% BMI Reduction at Week 12	-0.21 kilogram per square meter (kg/m^2) Standard Deviation 2.712	-0.73 kilogram per square meter (kg/m^2) Standard Deviation 1.517

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo n=7 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=6 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Percent Change in BMI From Baseline up to Week 52 in Participants Who Also Had the Outcome of Achieving at Least a 5% BMI Reduction at Week 12	-0.23 percent change Standard Deviation 7.741	-1.52 percent change Standard Deviation 3.967

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo n=7 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=4 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Number of Participants Who Achieved at Least a 5% or 10% BMI Reduction up to Week 52 Who Also Achieved at Least a 5% BMI Reduction at Week 12	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo n=37 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=29 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Waist Circumference From Baseline up to Week 52	-0.1 centimeter (cm) Standard Deviation 6.15	-2.7 centimeter (cm) Standard Deviation 8.28

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

DEXA is used to assess changes in body composition, including total fat and lean body mass and appendicular skeletal fat and muscle mass. DEXA instruments has a source that generates x-rays split into two energies which measures bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) are estimated.

Outcome measures

Measure	Placebo n=19 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=19 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Total Body Fat Mass From Baseline up to Week 52 Using Dual-energy X-ray Absorptiometry (DEXA)	1.35 kilogram (kg) Standard Deviation 5.059	0.98 kilogram (kg) Standard Deviation 3.944

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

DEXA is used to assess changes in body composition, including total fat and lean body mass and appendicular skeletal fat and muscle mass. DEXA instruments has a source that generates x-rays split into two energies which measures bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) are estimated.

Outcome measures

Measure	Placebo n=19 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=19 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Total Body Lean Mass From Baseline up to Week 52 Using DEXA	1.31 kilogram (kg) Standard Deviation 2.399	2.51 kilogram (kg) Standard Deviation 3.114

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Only one participant with Type 2 diabetes mellitus was enrolled in the Lorcaserin 20 mg arm of this study, who didn't make it to Week 52 therefore, data for this outcome measure was not collected and analyzed.

Percent change in HbA1c was analyzed for participants with Type 2 diabetes mellitus at baseline. Percent change from baseline was calculated as: [post-baseline value minus the baseline value]/baseline value)*100.

Outcome measures

Measure	Placebo Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=1 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Percent Change in Hemoglobin A1c (HbA1c) From Baseline up to Week 52 in Participants With Type 2 Diabetes Mellitus at Baseline	—	NA percent change Standard Deviation NA Only one participant with Type 2 diabetes mellitus was enrolled in the Lorcaserin 20 mg arm of this study, who didn't make it to Week 52 therefore, data for this outcome measure was not collected and analyzed.

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Only one participant with Type 2 diabetes mellitus was enrolled in the Lorcaserin 20 mg arm of this study, who didn't make it to Week 52 therefore, data for this outcome measure was not collected and analyzed.

Change in fasting glucose was analyzed for participants with Type 2 diabetes mellitus at baseline. Change from baseline was calculated as the post-baseline value minus the baseline value.

Outcome measures

Measure	Placebo Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=1 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Fasting Plasma Glucose From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline	—	NA millimoles per liter (mmol/L) Standard Deviation NA Only one participant with Type 2 diabetes mellitus was enrolled in the Lorcaserin 20 mg arm of this study, who didn't make it to Week 52 therefore, data for this outcome measure was not collected and analyzed.

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Only one participant with Type 2 diabetes mellitus was enrolled in the Lorcaserin 20 mg arm of this study, who didn't make it to Week 52 therefore, data for this outcome measure was not collected and analyzed.

Change in fasting insulin was analyzed for participants with Type 2 diabetes mellitus at baseline. Change from baseline was calculated as the post-baseline value minus the baseline value.

Outcome measures

Measure	Placebo Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=1 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Fasting Insulin From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline	—	NA milliunits per liter (mU/L) Standard Deviation NA Only one participant with Type 2 diabetes mellitus was enrolled in the Lorcaserin 20 mg arm of this study, who didn't make it to Week 52 therefore, data for this outcome measure was not collected and analyzed.

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Only one participant with Type 2 diabetes mellitus was enrolled in the Lorcaserin 20 mg arm of this study, who didn't make it to Week 52 therefore, data for this outcome measure was not collected and analyzed.

HOMA-IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR=fasting plasma insulin (micro international units per milliliter [µIU/mL]*fasting plasma glucose (mmol/L)/22.5. A higher number indicates a greater insulin resistance.

Outcome measures

Measure	Placebo Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=1 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Homeostatic Model Assessment-insulin Resistance (HOMA-IR) From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline	—	NA nanomoles per liter (nmol/L) Standard Deviation NA Only one participant with Type 2 diabetes mellitus was enrolled in the Lorcaserin 20 mg arm of this study, who didn't make it to Week 52 therefore, data for this outcome measure was not collected and analyzed.

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo n=36 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=30 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Fasting Plasma Glucose From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline	-0.10 millimoles per liter (mmol/L) Standard Deviation 0.856	-0.02 millimoles per liter (mmol/L) Standard Deviation 0.399

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo n=36 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=30 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Fasting Insulin From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline	2.26 milliunits per liter (mU/L) Standard Deviation 11.872	6.03 milliunits per liter (mU/L) Standard Deviation 31.811

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

HOMA-IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR=fasting plasma insulin (µIU/mL*fasting plasma glucose (mmol/L)/22.5. A higher number indicates a greater insulin resistance.

Outcome measures

Measure	Placebo n=34 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=30 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in HOMA-IR From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline	0.25 nanomoles per liter (nmol/L) Standard Deviation 3.668	1.25 nanomoles per liter (nmol/L) Standard Deviation 6.886

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Systolic blood pressure is the maximum arterial pressure during contraction of the ventricles of the heart. Diastolic blood pressure is the minimum arterial pressure during relaxation and dilatation of the ventricles of the heart when the ventricles fill with blood.

Outcome measures

Measure	Placebo n=37 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=30 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Blood Pressure (Systolic and Diastolic) From Baseline up to Week 52 Change in Systolic Blood Pressure from Baseline up to Week 52	0.6 millimeters of Mercury (mmHg) Standard Deviation 15.79	1.4 millimeters of Mercury (mmHg) Standard Deviation 12.98
Change in Blood Pressure (Systolic and Diastolic) From Baseline up to Week 52 Change in Diastolic Blood Pressure from Baseline up to Week 52	1.7 millimeters of Mercury (mmHg) Standard Deviation 9.80	2.1 millimeters of Mercury (mmHg) Standard Deviation 10.00

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Heart rate is the number of heart beats per unit of time, usually per minute.

Outcome measures

Measure	Placebo n=37 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=30 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Heart Rate From Baseline up to Week 52	-1.3 beats per minute Standard Deviation 10.25	0.7 beats per minute Standard Deviation 9.59

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Total Cholesterol is a measure of the total amount of cholesterol in blood. It includes both LDL cholesterol and HDL cholesterol. LDL cholesterol is often called the "bad" cholesterol because it collects in the walls of blood vessels, raising chances of health problems like a heart attack or stroke. HDL cholesterol is known as the "good" cholesterol because it helps remove other forms of cholesterol from bloodstream. Triglycerides are the most common type of fat in the body.

Outcome measures

Measure	Placebo n=37 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=29 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Change in Fasting Lipid Profile (Total Cholesterol, Low-density Lipoprotein [LDL] Cholesterol, High-density Lipoprotein [HDL] Cholesterol, Triglycerides) From Baseline up to Week 52 Total Cholesterol	0.20 millimoles per liter (mmol/L) Standard Deviation 0.548	0.01 millimoles per liter (mmol/L) Standard Deviation 0.590
Change in Fasting Lipid Profile (Total Cholesterol, Low-density Lipoprotein [LDL] Cholesterol, High-density Lipoprotein [HDL] Cholesterol, Triglycerides) From Baseline up to Week 52 LDL Cholesterol	0.21 millimoles per liter (mmol/L) Standard Deviation 0.460	-0.02 millimoles per liter (mmol/L) Standard Deviation 0.441
Change in Fasting Lipid Profile (Total Cholesterol, Low-density Lipoprotein [LDL] Cholesterol, High-density Lipoprotein [HDL] Cholesterol, Triglycerides) From Baseline up to Week 52 HDL Cholesterol	0.00 millimoles per liter (mmol/L) Standard Deviation 0.146	0.03 millimoles per liter (mmol/L) Standard Deviation 0.173
Change in Fasting Lipid Profile (Total Cholesterol, Low-density Lipoprotein [LDL] Cholesterol, High-density Lipoprotein [HDL] Cholesterol, Triglycerides) From Baseline up to Week 52 Triglycerides	-0.02 millimoles per liter (mmol/L) Standard Deviation 0.561	-0.01 millimoles per liter (mmol/L) Standard Deviation 0.603

SECONDARY outcome

Timeframe: Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Hypertension is defined as abnormally high blood pressure.

Outcome measures

Measure	Placebo n=37 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=30 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Percentage of Participants With Prehypertension or Primary Hypertension at Week 52	45.9 percentage of participants	63.3 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Dyslipidemia is defined as abnormally high cholesterol.

Outcome measures

Measure	Placebo n=37 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=30 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Percentage of Participants With Dyslipidemia at Week 52	64.9 percentage of participants	56.7 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Treatment compliance is defined as: (Total number of tablets dispensed minus total number of tablets lost or returned)/total number of tablets participant should have taken during the actual treatment. Compliance to study drug was categorized as less than (<) 80%, 80% to 100%, greater than (>) 100% to less than equal to (<=) 120%, and >120%.

Outcome measures

Measure	Placebo n=139 Participants Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=136 Participants Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Percentage of Participants by Study Drug Compliance Category During 52 Weeks of Treatment <80%	26.6 percentage of participants	28.7 percentage of participants
Percentage of Participants by Study Drug Compliance Category During 52 Weeks of Treatment 80% to 100%	61.9 percentage of participants	65.4 percentage of participants
Percentage of Participants by Study Drug Compliance Category During 52 Weeks of Treatment >100% to <= 120%	7.9 percentage of participants	3.7 percentage of participants
Percentage of Participants by Study Drug Compliance Category During 52 Weeks of Treatment >120%	1.4 percentage of participants	1.5 percentage of participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Lorcaserin 20 mg

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=139 participants at risk Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=136 participants at risk Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Hepatobiliary disorders Cholecystitis	0.00% 0/139 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.74% 1/136 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Hepatobiliary disorders Cholecystitis acute	0.72% 1/139 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/136 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Injury, poisoning and procedural complications Fibula fracture	0.72% 1/139 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/136 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Nervous system disorders Hemiparesis	0.00% 0/139 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.74% 1/136 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Other adverse events

Measure	Placebo n=139 participants at risk Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.	Lorcaserin 20 mg n=136 participants at risk Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
Gastrointestinal disorders Nausea	2.2% 3/139 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	5.9% 8/136 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Nasopharyngitis	6.5% 9/139 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	5.9% 8/136 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Upper respiratory tract infection	4.3% 6/139 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.1% 11/136 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Nervous system disorders Headache	4.3% 6/139 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	5.9% 8/136 • Up to 56 weeks The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: 1-888-274-2378

Email: esi_medinfo@eisai.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place