BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00395135
First received: October 31, 2006
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Obesity
Drug: Lorcaserin 10 mg BID
Drug: Matching Placebo BID
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:
  • Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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.


  • Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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:
  • Year 1: Percent Change in Body Weight From Baseline to Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Year 1: The % change in body weight (kg) from baseline to week 52.

  • Year 2: Percent Change in Body Weight From Week 52 to Week 104 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Year 2: The % change in body weight (kg) from week 52 to week 104.


Enrollment: 3182
Study Start Date: November 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided by Arena Pharmaceuticals

Additional 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
Study First Received: October 31, 2006
Results First Received: January 4, 2013
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014