Phase 3
Completed N=4,008
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
Source: ClinicalTrials.gov NCT00603902 ↗Enrolled (actual)
4,008
Serious AEs
2.8%
Results posted
Feb 2013
Primary outcomePrimary: Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 — 40.2; 47.2; 25.0 percentage of participants — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 |
40.2; 47.2; 25.0 | <0.0001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 52 |
-4.75; -5.84; -2.84 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00603902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.