A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial

J Clin Endocrinol Metab. 2011 Oct;96(10):3067-77. doi: 10.1210/jc.2011-1256. Epub 2011 Jul 27.

Abstract

Context: Lorcaserin is a novel selective agonist of the serotonin 2C receptor.

Objective: Our objective was to evaluate the effects of lorcaserin on body weight, cardiovascular risk factors, and safety in obese and overweight patients.

Design and setting: This randomized, placebo-controlled, double-blind, parallel arm trial took place at 97 U.S. research centers.

Patients: Patients included 4008 patients, aged 18-65 yr, with a body mass index between 30 and 45 kg/m(2) or between 27 and 29.9 kg/m(2) with an obesity-related comorbid condition.

Interventions: Patients were randomly assigned in a 2:1:2 ratio to receive lorcaserin 10 mg twice daily (BID), lorcaserin 10 mg once daily (QD), or placebo. All patients received diet and exercise counseling.

Main outcome measures: The ordered primary endpoints were proportion of patients achieving at least 5% reduction in body weight, mean change in body weight, and proportion of patients achieving at least 10% reduction in body weight at 1 yr. Serial echocardiograms monitored heart valve function.

Results: Significantly more patients treated with lorcaserin 10 mg BID and QD lost at least 5% of baseline body weight (47.2 and 40.2%, respectively) as compared with placebo (25.0%, P < 0.001 vs. lorcaserin BID). Least squares mean (95% confidence interval) weight loss with lorcaserin BID and QD was 5.8% (5.5-6.2%) and 4.7% (4.3-5.2%), respectively, compared with 2.8% (2.5-3.2%) with placebo (P < 0.001 vs. lorcaserin BID; least squares mean difference, 3.0%). Weight loss of at least 10% was achieved by 22.6 and 17.4% of patients receiving lorcaserin 10 mg BID and QD, respectively, and 9.7% of patients in the placebo group (P < 0.001 vs. lorcaserin BID). Headache, nausea, and dizziness were the most common lorcaserin-related adverse events. U.S. Food and Drug Administration-defined echocardiographic valvulopathy occurred in 2.0% of patients on placebo and 2.0% on lorcaserin 10 mg BID.

Conclusions: Lorcaserin administered in conjunction with a lifestyle modification program was associated with dose-dependent weight loss that was significantly greater than with placebo.

Trial registration: ClinicalTrials.gov NCT00603902.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorptiometry, Photon
  • Adolescent
  • Adult
  • Aged
  • Anti-Obesity Agents / adverse effects
  • Anti-Obesity Agents / therapeutic use*
  • Benzazepines / adverse effects
  • Benzazepines / therapeutic use*
  • Body Mass Index
  • Cardiovascular Diseases / epidemiology
  • Double-Blind Method
  • Echocardiography
  • Female
  • Humans
  • Lipids / blood
  • Male
  • Middle Aged
  • Obesity / complications
  • Obesity / drug therapy*
  • Overweight / complications
  • Overweight / drug therapy*
  • Receptor, Serotonin, 5-HT2C / drug effects
  • Risk Factors
  • Sample Size
  • Serotonin 5-HT2 Receptor Agonists / adverse effects
  • Serotonin 5-HT2 Receptor Agonists / therapeutic use*
  • Weight Loss / drug effects*
  • Young Adult

Substances

  • Anti-Obesity Agents
  • Benzazepines
  • Lipids
  • Receptor, Serotonin, 5-HT2C
  • Serotonin 5-HT2 Receptor Agonists
  • lorcaserin

Associated data

  • ClinicalTrials.gov/NCT00603902