Phase 3
Completed N=3,182
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
Source: ClinicalTrials.gov NCT00395135 ↗Enrolled (actual)
3,182
Serious AEs
2.5%
Results posted
Feb 2013
Primary outcomePrimary: Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 — 47.5; 20.3 percentage of participants — p=<0.0001
Summary
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 |
47.5; 20.3 | <0.0001 sig |
| PRIMARY Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 |
67.9; 50.3 | — |
| SECONDARY Year 1: Percent Change in Body Weight From Baseline to Week 52 |
-5.87; -2.20 | <0.001 sig |
| SECONDARY Year 2: Percent Change in Body Weight From Week 52 to Week 104 |
2.79; 5.38; 1.15 | <0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00395135). 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.