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BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

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ClinicalTrials.gov Identifier: NCT00395135
Recruitment Status : Completed
First Posted : November 2, 2006
Results First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Brief Summary:
The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104)

Condition or disease Intervention/treatment Phase
Obesity Drug: Lorcaserin 10 mg BID Drug: Matching Placebo BID Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management; A 104-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Obese Patients
Study Start Date : November 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Lorcaserin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening
Drug: Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.
Other Name: APD356
Placebo Comparator: Matching Placebo BID
Matching placebo tablet each morning and evening
Drug: Matching Placebo BID
Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.



Primary Outcome Measures :
  1. Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 [ Time Frame: 52 weeks ]

    The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1.

    Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1.


  2. Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 [ Time Frame: 104 weeks ]
    The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2.


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

  2. Year 2: Percent Change in Body Weight From Week 52 to Week 104 [ Time Frame: 52 weeks ]
    Year 2: The % change in body weight (kg) from week 52 to week 104.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese adults with a BMI 30 to 45 kg/m2 or overweight adults with a BMI 27 to 29.9 kg/m2 and at least one obesity-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, glucose intolerance, sleep apnea)
  • Ability to complete a 2 year study

Exclusion Criteria:

  • Diabetes
  • Pregnancy
  • History of 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): NCT00395135


Locations
United States, California
Arena Pharmaceuticals, Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Study Director: William Shanahan, MD Arena Pharmaceuticals
Principal Investigator: Steven Smith, MD Pennington Biomedical Research Center
Principal Investigator: Neil Weissman, MD MedStar Health Research Institute, Georgetown University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00395135     History of Changes
Other Study ID Numbers: APD356-009
First Posted: November 2, 2006    Key Record Dates
Results First Posted: February 7, 2013
Last Update Posted: February 7, 2013
Last Verified: January 2013

Keywords provided by Arena Pharmaceuticals:
Obesity
Weight loss
lorcaserin
APD356
BLOOM
Hypertension
Dyslipidemia
Sleep apnea
glucose tolerance
cardiovascular disease
Arena

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms