BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4008 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.

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Detailed Description

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Randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and female volunteers aged 18 to 65 years inclusive.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lorcaserin 10 mg QD

Lorcaserin 10 mg tablet each morning and placebo tablet each evening

Group Type EXPERIMENTAL

Lorcaserin 10 mg once daily (QD)

Intervention Type DRUG

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

Lorcaserin 10 mg BID

Lorcaserin 10 mg tablet each morning and evening

Group Type EXPERIMENTAL

Lorcaserin 10 mg twice a day (BID)

Intervention Type DRUG

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

Matching Placebo

Matching placebo tablet each morning and evening

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

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

Interventions

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Lorcaserin 10 mg once daily (QD)

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

Intervention Type DRUG

Lorcaserin 10 mg twice a day (BID)

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

Intervention Type DRUG

Matching Placebo

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

Intervention Type DRUG

Other Intervention Names

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APD356 APD356

Eligibility Criteria

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Inclusion Criteria

* Overweight and/or obese men and women with a body mass index (BMI) 30 to 45 kg/m2 with or without a comorbid condition (e.g., hypertension, dyslipidemia, CV disease, glucose intolerance, sleep apnea), or 27 to 29.9 kg/m2 with at least one comorbid condition.
* Ability to complete a 1 year study

Exclusion Criteria

* Pregnancy
* Diabetes mellitus (type I, II or other)
* History of symptomatic heart valve disease
* Serious or unstable current or past medical conditions

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No