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OpenTrials
Completed

NCT Number: NCT00395135

BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

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)

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Key information

Conditions

Obesity Apnea Body Weight Body Weight Changes Cardiovascular Diseases Dyslipidemias Dyssomnias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arena Pharmaceuticals, Inc.

San Diego, California, 92121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorcaserin 10 mg BID

Drug

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

Other names: APD356

Matching Placebo BID

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 2, 2006
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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