Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00603902
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : February 7, 2013
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.

Condition or disease Intervention/treatment Phase
Obesity Drug: Lorcaserin 10 mg once daily (QD) Drug: Lorcaserin 10 mg twice a day (BID) Drug: Matching Placebo Phase 3

Detailed Description:
Randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and female volunteers aged 18 to 65 years inclusive.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4008 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients
Study Start Date : January 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Lorcaserin

Arm Intervention/treatment
Experimental: Lorcaserin 10 mg QD
Lorcaserin 10 mg tablet each morning and placebo tablet each evening
Drug: Lorcaserin 10 mg once daily (QD)
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Other Name: APD356

Experimental: Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening
Drug: Lorcaserin 10 mg twice a day (BID)
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
Other Name: APD356

Placebo Comparator: Matching Placebo
Matching placebo tablet each morning and evening
Drug: Matching Placebo
Matching placebo tablet each morning and evening for a duration of 52 weeks.




Primary Outcome Measures :
  1. Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 [ Time Frame: Baseline and Week 52 ]
    The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.


Secondary Outcome Measures :
  1. Percent Change in Body Weight From Baseline to Week 52 [ Time Frame: Baseline and Week 52 ]
    The percent change in body weight (kg) from baseline to week 52.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Overweight and/or obese men and women with a body mass index (BMI) 30 to 45 kg/m2 with or without a comorbid condition (e.g., hypertension, dyslipidemia, CV disease, glucose intolerance, sleep apnea), or 27 to 29.9 kg/m2 with at least one comorbid condition.
  • Ability to complete a 1 year study

Exclusion Criteria:

  • Pregnancy
  • Diabetes mellitus (type I, II or other)
  • History of symptomatic heart valve disease
  • Serious or unstable current or past medical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603902


Locations
Layout table for location information
United States, California
Arena Pharmaceuticals, Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
Eisai Inc.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00603902    
Other Study ID Numbers: APD356-011
First Posted: January 29, 2008    Key Record Dates
Results First Posted: February 7, 2013
Last Update Posted: October 4, 2019
Last Verified: August 2019
Keywords provided by Eisai Inc.:
lorcaserin
APD356
Obesity
Weight loss
BLOSSOM
Hypertension
Dyslipidemia
Sleep apnea
glucose tolerance
cardiovascular disease
Arena
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight