BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management - Full Text View

Sponsor:	Arena Pharmaceuticals
Information provided by:	Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00395135

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 Drug: matching placebo	Phase III

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:

MedlinePlus related topics: High Blood Pressure Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:

Year 1: Proportion (%) of patients achieving > or = 5% weight reduction at the end of the first year of treatment (Week 52) [ Designated as safety issue: No ]
Year 2: Proportion of patients maintaining > or = 5% weight reduction at the end of Year 2 (Week 104) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in body weight at the end of Year 1 [ Designated as safety issue: No ]
Additional body weight change during Year 2 [ Designated as safety issue: No ]
Change in waist and hip measurements [ Designated as safety issue: No ]
Change in cardiovascular risk factors [ Designated as safety issue: No ]
Change in use of concomitant medications for comorbidities (i.e., hypertension, dyslipidemia) [ Designated as safety issue: No ]
Change in Quality of Life measures [ Designated as safety issue: No ]

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	Drug: lorcaserin 10 mg, PO, BID
Placebo Comparator: matching placebo BID	Drug: matching placebo placebo, PO, BID

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
San Diego, California, United States, 92121

Sponsors and Collaborators

Arena Pharmaceuticals

Investigators

Study Director:	Christen Anderson, MD, PhD	Arena Pharmaceuticals
Principal Investigator:	Steven Smith, MD	Pennington Biomedical Research Center
Principal Investigator:	Neil Weissman, MD

More Information

Additional Information:

Arena Pharmaceuticals, Inc. Home Page This link exits the ClinicalTrials.gov site

No publications provided by Arena Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Smith SR, Weissman NJ, Anderson CM, Sanchez M, Chuang E, Stubbe S, Bays H, Shanahan WR; Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) Study Group. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010 Jul 15;363(3):245-56.

Responsible Party:	c/o Vice President and Chief Medical Officer, Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00395135 History of Changes
Other Study ID Numbers:	APD356-009
Study First Received:	October 31, 2006
Last Updated:	July 27, 2009
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 February 09, 2012