COMPLETEDResults postedPhase 3

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)

Sponsor

Eisai Inc.

Enrollment

3,182 participants

Sites

1 locations

Start Date

November 2006

Completion

February 2009

ObesityLorcaserin 10 mg BIDMatching Placebo BID

Enrollment & Timeline

Completed

Target N

3,182

participants

Sites

locations

Duration

2.3 years

total trial span

Rate

118

pts/month needed

At 1 sites, each site needs to enroll approximately 118.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Primary Outcomes

Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52

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.

Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104

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.

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

all

Healthy Volunteers

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials.

Weissman Neil J, Smith Steven R, Fain Randi et al.Obesity (Silver Spring, Md.)2017

DOI PubMed

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

Handelsman Yehuda, Fain Randi, Wang Zhixiao et al.Postgraduate medicine2017

DOI PubMed

Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis.

Nguyen Charles T, Zhou Sharon, Shanahan William et al.Clinical therapeutics2017

DOI PubMed

Evaluation of lorcaserin on progression of prediabetes to type 2 diabetes and reversion to euglycemia.

Nesto Richard, Fain Randi, Li Yuhan et al.Postgraduate medicine2017

DOI PubMed

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

Weissman Neil J, Sanchez Matilde, Koch Gary G et al.Circulation. Cardiovascular imaging2013

DOI PubMed

Multicenter, placebo-controlled trial of lorcaserin for weight management.

Smith Steven R, Weissman Neil J, Anderson Christen M et al.The New England journal of medicine2010

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Fetching protocol from ClinicalTrials.gov…

COMPLETEDResults postedPhase 3

BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Sponsor

Eisai Inc.

Enrollment

3,182 participants

Sites

1 locations

Start Date

November 2006

Completion

February 2009

ObesityLorcaserin 10 mg BIDMatching Placebo BID

Enrollment & Timeline

Completed

Target N

3,182

participants

Sites

locations

Duration

2.3 years

total trial span

Rate

118

pts/month needed

At 1 sites, each site needs to enroll approximately 118.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Primary Outcomes

Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52

52 weeks

Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104

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.

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

all

Healthy Volunteers

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials.

Weissman Neil J, Smith Steven R, Fain Randi et al.Obesity (Silver Spring, Md.)2017

DOI PubMed

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

Handelsman Yehuda, Fain Randi, Wang Zhixiao et al.Postgraduate medicine2017

DOI PubMed

Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis.

Nguyen Charles T, Zhou Sharon, Shanahan William et al.Clinical therapeutics2017

DOI PubMed

Evaluation of lorcaserin on progression of prediabetes to type 2 diabetes and reversion to euglycemia.

Nesto Richard, Fain Randi, Li Yuhan et al.Postgraduate medicine2017

DOI PubMed

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

Weissman Neil J, Sanchez Matilde, Koch Gary G et al.Circulation. Cardiovascular imaging2013

DOI PubMed

Multicenter, placebo-controlled trial of lorcaserin for weight management.

Smith Steven R, Weissman Neil J, Anderson Christen M et al.The New England journal of medicine2010

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Enrollment & Timeline

Primary Outcomes

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Enrollment & Timeline

Primary Outcomes

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Trial Sites (1)