Completed

Phase 3
Age: 18Years - 65Years
All Genders
ID00395135

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

Led by Eisai Inc. · Updated on 2019-10-02

3182

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Diabetes
  • Pregnancy
  • History of heart valve disease
  • Serious or unstable current or past medical conditions

Trial Site Locations

Total: 1 location

1

Arena Pharmaceuticals, Inc.

San Diego, California, United States, 92121

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with ≥5% weight loss.

Yehuda Handelsman, Randi Fain, Zhixiao Wang...

https://pubmed.ncbi.nlm.nih.gov/27659698

Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials.

Neil J Weissman, Matilde Sanchez, Gary G Koch...

https://pubmed.ncbi.nlm.nih.gov/23661689