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BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Primary Purpose

Obesity

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lorcaserin 10 mg BID

Matching Placebo BID

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss, lorcaserin, APD356, BLOOM, Hypertension, Dyslipidemia, Sleep apnea, glucose tolerance, cardiovascular disease, Arena

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arena Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lorcaserin 10 mg BID

Matching Placebo BID

Arm Description

Lorcaserin 10 mg tablet each morning and evening

Matching placebo tablet each morning and evening

Outcomes

Primary Outcome Measures

Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52

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

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

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

Year 2: The % change in body weight (kg) from week 52 to week 104.

Full Information

NCT ID

NCT00395135

First Posted

October 31, 2006

Last Updated

September 19, 2019

Sponsor

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00395135

Brief Title

BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

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 Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Inc.

4. Oversight

Data Monitoring Committee

Yes

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Weight loss, lorcaserin, APD356, BLOOM, Hypertension, Dyslipidemia, Sleep apnea, glucose tolerance, cardiovascular disease, Arena

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lorcaserin 10 mg BID

Arm Type

Experimental

Arm Description

Lorcaserin 10 mg tablet each morning and evening

Arm Title

Matching Placebo BID

Arm Type

Placebo Comparator

Arm Description

Matching placebo tablet each morning and evening

Intervention Type

Drug

Intervention Name(s)

Lorcaserin 10 mg BID

Other Intervention Name(s)

APD356

Intervention Description

Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.

Intervention Type

Drug

Intervention Name(s)

Matching Placebo BID

Intervention Description

Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.

Primary Outcome Measure Information:

Title

Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52

Description

Time Frame

52 weeks

Title

Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104

Description

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.

Time Frame

104 weeks

Secondary Outcome Measure Information:

Title

Year 1: Percent Change in Body Weight From Baseline to Week 52

Description

Year 1: The % change in body weight (kg) from baseline to week 52.

Time Frame

52 weeks

Title

Year 2: Percent Change in Body Weight From Week 52 to Week 104

Description

Year 2: The % change in body weight (kg) from week 52 to week 104.

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Arena Pharmaceuticals, Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27888609

Citation

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.

Results Reference

derived

PubMed Identifier

27659698

Citation

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.

Results Reference

derived

PubMed Identifier

27206567

Citation

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.

Results Reference

derived

PubMed Identifier

27116910

Citation

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.

Results Reference

derived

PubMed Identifier

23661689

Citation

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.

Results Reference

derived

PubMed Identifier

20647200

Citation

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.

Results Reference

derived

Links:

URL

http://www.arenapharm.com

Description

Arena Pharmaceuticals, Inc. Home Page

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BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

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