Trial Outcomes & Findings for Lifestyle Modification and Lorcaserin for Weight Loss Maintenance (NCT NCT02388568)

NCT ID: NCT02388568

Last Updated: 2018-06-11

Results Overview

This is the change in weight from randomization to week 52. This does not include the weight loss in the 14-week LCD.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 137 participants
• Primary outcome timeframe: 52 weeks post-randomization
• Results posted on: 2018-06-11

Participant Flow

Participant milestones

Measure	Lorcaserin Plus Lifestyle Modification Lorcaserin: Lorcaserin plus Lifestyle Modification	Placebo Plus Lifestyle Modification Placebo: Placebo plus Lifestyle Modification
Overall Study STARTED	69	68
Overall Study COMPLETED	59	53
Overall Study NOT COMPLETED	10	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lifestyle Modification and Lorcaserin for Weight Loss Maintenance

Baseline characteristics by cohort

Measure	Lorcaserin Plus Lifestyle Modification n=69 Participants Lorcaserin: Lorcaserin plus Lifestyle Modification	Placebo Plus Lifestyle Modification n=68 Participants Placebo: Placebo plus Lifestyle Modification	Total n=137 Participants Total of all reporting groups
Age, Continuous	45.4 years STANDARD_DEVIATION 10.5 • n=93 Participants	47.7 years STANDARD_DEVIATION 9.8 • n=4 Participants	46.1 years STANDARD_DEVIATION 10.1 • n=27 Participants
Sex: Female, Male Female	59 Participants n=93 Participants	59 Participants n=4 Participants	118 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	9 Participants n=4 Participants	19 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	49 Participants n=93 Participants	45 Participants n=4 Participants	94 Participants n=27 Participants
Race/Ethnicity, Customized White	15 Participants n=93 Participants	18 Participants n=4 Participants	33 Participants n=27 Participants
Race/Ethnicity, Customized Asian	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Multiracial or other	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Height	168.8 cm STANDARD_DEVIATION 8.6 • n=93 Participants	165.7 cm STANDARD_DEVIATION 9.4 • n=4 Participants	167.2 cm STANDARD_DEVIATION 9.1 • n=27 Participants

PRIMARY outcome

Timeframe: 52 weeks post-randomization

This is the change in weight from randomization to week 52. This does not include the weight loss in the 14-week LCD.

Outcome measures

Measure	Lorcaserin Plus Lifestyle Modification n=69 Participants Lorcaserin: Lorcaserin plus Lifestyle Modification	Placebo Plus Lifestyle Modification n=68 Participants Placebo: Placebo plus Lifestyle Modification
Change in Weight (kg)	2.0 kg Standard Error 0.8	2.5 kg Standard Error 0.8

PRIMARY outcome

Timeframe: 52 weeks post-randomization

This is the number of participants who maintained >=5% loss of initial weight in the randomization to week 52 trial period.

Outcome measures

Measure	Lorcaserin Plus Lifestyle Modification n=69 Participants Lorcaserin: Lorcaserin plus Lifestyle Modification	Placebo Plus Lifestyle Modification n=68 Participants Placebo: Placebo plus Lifestyle Modification
Proportion Maintaining >= 5% Loss of Initial Weight	38 Participants	29 Participants

SECONDARY outcome

Timeframe: 52 weeks post-randomization

The % change in body weight from randomization to week 52.

Outcome measures

Measure	Lorcaserin Plus Lifestyle Modification n=69 Participants Lorcaserin: Lorcaserin plus Lifestyle Modification	Placebo Plus Lifestyle Modification n=68 Participants Placebo: Placebo plus Lifestyle Modification
Body Weight (% Change)	1.8 % change Standard Error 0.8	2.2 % change Standard Error 0.8

SECONDARY outcome

Timeframe: 52 weeks post-randomization

This is the number of participants who maintained >=10% loss of initial weight in the randomization to week 52 trial period.

Outcome measures

Measure	Lorcaserin Plus Lifestyle Modification n=69 Participants Lorcaserin: Lorcaserin plus Lifestyle Modification	Placebo Plus Lifestyle Modification n=68 Participants Placebo: Placebo plus Lifestyle Modification
Proportion Maintaining >= 10% Loss of Initial Weight	20 Participants	20 Participants

SECONDARY outcome

Timeframe: -14 week (start of LCD program) to week 52

This is the change in weight from baseline (screening visit) to the final week 52 medical assessment visit.

Outcome measures

Measure	Lorcaserin Plus Lifestyle Modification n=69 Participants Lorcaserin: Lorcaserin plus Lifestyle Modification	Placebo Plus Lifestyle Modification n=68 Participants Placebo: Placebo plus Lifestyle Modification
Body Weight	-9.4 kg Standard Error 0.9	-7.5 kg Standard Error 1.0

SECONDARY outcome

Timeframe: -14 week (start of LCD program) to week 52

This is the change in weight from the baseline (screening visit) to the final week 52 medical assessment visit.

Outcome measures

Measure	Lorcaserin Plus Lifestyle Modification n=69 Participants Lorcaserin: Lorcaserin plus Lifestyle Modification	Placebo Plus Lifestyle Modification n=68 Participants Placebo: Placebo plus Lifestyle Modification
Body Weight (% Change)	-7.8 % change Standard Error 0.8	-6.6 % change Standard Error 0.9

Adverse Events

Lorcaserin Plus Lifestyle Modification

Serious events: 2 serious events

Other events: 56 other events

Deaths: 0 deaths

Placebo Plus Lifestyle Modification

Serious events: 8 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lorcaserin Plus Lifestyle Modification n=69 participants at risk Lorcaserin: Lorcaserin plus Lifestyle Modification	Placebo Plus Lifestyle Modification n=68 participants at risk Placebo: Placebo plus Lifestyle Modification
Endocrine disorders Sialolithiasis/sialadenitis	1.4% 1/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	0.00% 0/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Skin and subcutaneous tissue disorders Staph cellulitis	1.4% 1/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	0.00% 0/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	2.9% 2/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	0.00% 0/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	1.5% 1/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Gastrointestinal disorders Cholelithiasis	0.00% 0/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	1.5% 1/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Cardiac disorders Hypertension	0.00% 0/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	1.5% 1/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Respiratory, thoracic and mediastinal disorders Lung nodules	0.00% 0/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	1.5% 1/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Reproductive system and breast disorders Pregnancy	0.00% 0/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	1.5% 1/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Nervous system disorders Vertigo	0.00% 0/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	1.5% 1/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.

Other adverse events

Measure	Lorcaserin Plus Lifestyle Modification n=69 participants at risk Lorcaserin: Lorcaserin plus Lifestyle Modification	Placebo Plus Lifestyle Modification n=68 participants at risk Placebo: Placebo plus Lifestyle Modification
Nervous system disorders Headache	17.4% 12/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	10.3% 7/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
General disorders Fatigue	15.9% 11/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	17.6% 12/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Gastrointestinal disorders Constipation	14.5% 10/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	4.4% 3/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
General disorders Dry mouth	10.1% 7/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	4.4% 3/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	7.2% 5/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	10.3% 7/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
General disorders Dizziness	5.8% 4/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	2.9% 2/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Musculoskeletal and connective tissue disorders Musculoskeletal injury	4.3% 3/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	8.8% 6/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 2/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	7.4% 5/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.
Respiratory, thoracic and mediastinal disorders Asthma exacerbation	2.9% 2/69 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.	5.9% 4/68 • Adverse events for phase 2 of the trial were reported from the time of randomization to 13 months after randomization. Safety assessments included recording adverse events at all clinic visits; a physical examination, fasting blood test, and urine pregnancy test (as appropriate) at randomization, and weeks 24 and 52 of phase 2; and nine brief medical visits to measure vital signs, review health, and administer the Columbia-Suicide Severity Rating Scale.

Additional Information

Dr. Jena Shaw Tronieri

The University of Pennsylvania's Center for Weight and Eating Disorders

Phone: 215-746-5045

Email: jena.tronieri@pennmedicine.upenn.edu

Results disclosure agreements

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