BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Lorcaserin 10 mg BID
* Drug: Matching Placebo BID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lorcaserin 10 mg BID<br>Lorcaserin 10 mg tablet each morning and evening | Drug: Lorcaserin 10 mg BID<br>* Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.<br>* Other names: APD356;|
| Placebo Comparator: Matching Placebo BID<br>Matching placebo tablet each morning and evening | Drug: Matching Placebo BID<br>* Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | Year 2: The % change in body weight (kg) from week 52 to week 104. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight loss, lorcaserin, APD356, BLOOM, Hypertension, Dyslipidemia, Sleep apnea, glucose tolerance, cardiovascular disease, Arena