BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

September 19, 2019 updated by: Eisai Inc.

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3182

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Arena Pharmaceuticals, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks
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.
104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks
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.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 2, 2006

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APD356-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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