NCT00603902

A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients

Completed Phase 3 Results posted Last updated 19 September 2019

What this trial tests

Phase 3 trial testing Lorcaserin 10 mg once daily (QD) in Obesity in 4,008 participants. Completed in 1 August 2009.

Timeline

1 January 2008

Primary endpoint
1 July 2009

1 August 2009

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	4,008
Start date	1 January 2008
Primary completion	1 July 2009
Estimated completion	1 August 2009
Sites	1 location across United States

Drugs / interventions tested

• Lorcaserin 10 mg once daily (QD) — full drug profile →
• Lorcaserin 10 mg twice a day (BID) — full drug profile →
• Matching Placebo — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Eisai Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
  Time frame: Baseline and Week 52
  The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials.
   Weissman NJ, Sanchez M, Koch GG, Smith SR, et al · · 2013 · cited 46× · PMID 23661689 · DOI 10.1161/circimaging.112.000128
2. Evaluation of lorcaserin on progression of prediabetes to type 2 diabetes and reversion to euglycemia.
   Nesto R, Fain R, Li Y, Shanahan W. · · 2016 · cited 18× · PMID 27116910 · DOI 10.1080/00325481.2016.1178590
3. Abstracts from the 38th annual meeting of the society of general internal medicine.
   · 2015 · cited 14× · PMID 25869016 · DOI 10.1007/s11606-015-3271-0
4. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials.
   Weissman NJ, Smith SR, Fain R, Hall N, et al · · 2017 · cited 10× · PMID 27888609 · DOI 10.1002/oby.21695
5. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis.
   Nguyen CT, Zhou S, Shanahan W, Fain R. · · 2016 · cited 8× · PMID 27206567 · DOI 10.1016/j.clinthera.2016.04.004
6. Medicines for Obesity: Appraisal of Clinical Studies with Grading of Recommendations, Assessment, Development, and Evaluation Tool.
   Karavia EA, Giannopoulou PC, Konstantinopoulou V, Athanasopoulou K, et al · · 2023 · cited 3× · PMID 36771314 · DOI 10.3390/nu15030606
7. Effect of lorcaserin on weight reduction in persons with obstructive sleep apnea (OSA): a combined subgroup analysis from three randomized, controlled clinical trials.
   Fujioka K, Perdomo C, Malhotra M. · · 2019 · cited 3× · PMID 31275597 · DOI 10.1002/osp4.340
8. Effect of lorcaserin in different age groups: a post hoc analysis of patients from the BLOOM, BLOSSOM and BLOOM-DM studies.
   Fujioka K, Malhotra M, Perdomo C, Apovian CM. · · 2019 · cited 3× · PMID 31019729 · DOI 10.1002/osp4.335