BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

• ClinicalTrials.gov Identifier: NCT00395135
• Recruitment Status: Completed
• First Posted: November 2, 2006
• Results First Posted: February 7, 2013
• Last Update Posted: October 2, 2019
• Sponsor: Eisai Inc.
• Information provided by (Responsible Party): Eisai Inc.

Study Description

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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

Contacts and Locations

Locations

United States, California

Arena Pharmaceuticals, Inc.

San Diego, California, United States, 92121

Sponsors and Collaborators

Eisai Inc.

More Information

Additional Information:

Arena Pharmaceuticals, Inc. Home Page 

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

Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26.

Handelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19.

Nguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17.

Nesto R, Fain R, Li Y, Shanahan W. Evaluation of lorcaserin on progression of prediabetes to type 2 diabetes and reversion to euglycemia. Postgrad Med. 2016 May;128(4):364-70. doi: 10.1080/00325481.2016.1178590.

Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9.

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. doi: 10.1056/NEJMoa0909809.

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT00395135
• Other Study ID Numbers: APD356-009
• First Posted: November 2, 2006
• Results First Posted: February 7, 2013
• Last Update Posted: October 2, 2019
• Last Verified: January 2013

Keywords provided by Eisai Inc.:

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