BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

NCT00395135 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3182

Last updated 2019-10-02

Study results available
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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)

Conditions

Interventions

DRUG

Lorcaserin 10 mg BID

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

DRUG

Matching Placebo BID

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

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00395135 on ClinicalTrials.gov