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Lifestyle Modification and Lorcaserin for Weight Loss Maintenance

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ClinicalTrials.gov Identifier: NCT02388568
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: Lorcaserin
Drug: Placebo
Enrollment 137
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Hide Arm/Group Description Lorcaserin: Lorcaserin plus Lifestyle Modification Placebo: Placebo plus Lifestyle Modification
Period Title: Overall Study
Started 69 68
Completed 59 53
Not Completed 10 15
Arm/Group Title Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification Total
Hide Arm/Group Description Lorcaserin: Lorcaserin plus Lifestyle Modification Placebo: Placebo plus Lifestyle Modification Total of all reporting groups
Overall Number of Baseline Participants 69 68 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 68 participants 137 participants
45.4  (10.5) 47.7  (9.8) 46.1  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 68 participants 137 participants
Female
59
  85.5%
59
  86.8%
118
  86.1%
Male
10
  14.5%
9
  13.2%
19
  13.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 68 participants 137 participants
Black or African American
49
  71.0%
45
  66.2%
94
  68.6%
White
15
  21.7%
18
  26.5%
33
  24.1%
Asian
2
   2.9%
2
   2.9%
4
   2.9%
Multiracial or other
3
   4.3%
3
   4.4%
6
   4.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Hispanic Number Analyzed 69 participants 68 participants 137 participants
4
   5.8%
3
   4.4%
7
   5.1%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 69 participants 68 participants 137 participants
168.8  (8.6) 165.7  (9.4) 167.2  (9.1)
1.Primary Outcome
Title Change in Weight (kg)
Hide Description This is the change in weight from randomization to week 52. This does not include the weight loss in the 14-week LCD.
Time Frame 52 weeks post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Hide Arm/Group Description:
Lorcaserin: Lorcaserin plus Lifestyle Modification
Placebo: Placebo plus Lifestyle Modification
Overall Number of Participants Analyzed 69 68
Mean (Standard Error)
Unit of Measure: kg
2.0  (0.8) 2.5  (0.8)
2.Primary Outcome
Title Proportion Maintaining >= 5% Loss of Initial Weight
Hide Description This is the number of participants who maintained >=5% loss of initial weight in the randomization to week 52 trial period.
Time Frame 52 weeks post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Hide Arm/Group Description:
Lorcaserin: Lorcaserin plus Lifestyle Modification
Placebo: Placebo plus Lifestyle Modification
Overall Number of Participants Analyzed 69 68
Measure Type: Count of Participants
Unit of Measure: Participants
38
  55.1%
29
  42.6%
3.Secondary Outcome
Title Body Weight (% Change)
Hide Description The % change in body weight from randomization to week 52.
Time Frame 52 weeks post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Hide Arm/Group Description:
Lorcaserin: Lorcaserin plus Lifestyle Modification
Placebo: Placebo plus Lifestyle Modification
Overall Number of Participants Analyzed 69 68
Mean (Standard Error)
Unit of Measure: % change
1.8  (0.8) 2.2  (0.8)
4.Secondary Outcome
Title Proportion Maintaining >= 10% Loss of Initial Weight
Hide Description This is the number of participants who maintained >=10% loss of initial weight in the randomization to week 52 trial period.
Time Frame 52 weeks post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Hide Arm/Group Description:
Lorcaserin: Lorcaserin plus Lifestyle Modification
Placebo: Placebo plus Lifestyle Modification
Overall Number of Participants Analyzed 69 68
Measure Type: Count of Participants
Unit of Measure: Participants
20
  29.0%
20
  29.4%
5.Secondary Outcome
Title Body Weight
Hide Description This is the change in weight from baseline (screening visit) to the final week 52 medical assessment visit.
Time Frame -14 week (start of LCD program) to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Hide Arm/Group Description:
Lorcaserin: Lorcaserin plus Lifestyle Modification
Placebo: Placebo plus Lifestyle Modification
Overall Number of Participants Analyzed 69 68
Mean (Standard Error)
Unit of Measure: kg
-9.4  (0.9) -7.5  (1.0)
6.Secondary Outcome
Title Body Weight (% Change)
Hide Description This is the change in weight from the baseline (screening visit) to the final week 52 medical assessment visit.
Time Frame -14 week (start of LCD program) to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Hide Arm/Group Description:
Lorcaserin: Lorcaserin plus Lifestyle Modification
Placebo: Placebo plus Lifestyle Modification
Overall Number of Participants Analyzed 69 68
Mean (Standard Error)
Unit of Measure: % change
-7.8  (0.8) -6.6  (0.9)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Hide Arm/Group Description Lorcaserin: Lorcaserin plus Lifestyle Modification Placebo: Placebo plus Lifestyle Modification
All-Cause Mortality
Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Affected / at Risk (%) Affected / at Risk (%)
Total   0/69 (0.00%)   0/68 (0.00%) 
Hide Serious Adverse Events
Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Affected / at Risk (%) Affected / at Risk (%)
Total   2/69 (2.90%)   8/68 (11.76%) 
Cardiac disorders     
Hypertension *  0/69 (0.00%)  1/68 (1.47%) 
Endocrine disorders     
Sialolithiasis/sialadenitis *  1/69 (1.45%)  0/68 (0.00%) 
Gastrointestinal disorders     
Cholelithiasis *  0/69 (0.00%)  1/68 (1.47%) 
Nervous system disorders     
Vertigo *  0/69 (0.00%)  1/68 (1.47%) 
Reproductive system and breast disorders     
Pregnancy *  0/69 (0.00%)  1/68 (1.47%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia *  0/69 (0.00%)  2/68 (2.94%) 
Asthma Exacerbation *  0/69 (0.00%)  1/68 (1.47%) 
Lung nodules *  0/69 (0.00%)  1/68 (1.47%) 
Skin and subcutaneous tissue disorders     
Staph cellulitis *  1/69 (1.45%)  0/68 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Lorcaserin Plus Lifestyle Modification Placebo Plus Lifestyle Modification
Affected / at Risk (%) Affected / at Risk (%)
Total   56/69 (81.16%)   49/68 (72.06%) 
Gastrointestinal disorders     
Constipation   10/69 (14.49%)  3/68 (4.41%) 
General disorders     
Fatigue   11/69 (15.94%)  12/68 (17.65%) 
Dry mouth   7/69 (10.14%)  3/68 (4.41%) 
Dizziness   4/69 (5.80%)  2/68 (2.94%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal injury   3/69 (4.35%)  6/68 (8.82%) 
Pain in extremity   2/69 (2.90%)  5/68 (7.35%) 
Nervous system disorders     
Headache   12/69 (17.39%)  7/68 (10.29%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory infection   5/69 (7.25%)  7/68 (10.29%) 
Asthma exacerbation   2/69 (2.90%)  4/68 (5.88%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jena Shaw Tronieri
Organization: The University of Pennsylvania's Center for Weight and Eating Disorders
Phone: 215-746-5045
EMail: jena.tronieri@pennmedicine.upenn.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02388568    
Other Study ID Numbers: Eisai-819111
First Submitted: January 29, 2015
First Posted: March 17, 2015
Results First Submitted: February 26, 2018
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018