Date: 2014-10-29
Type of information: Results
phase:
Announcement: results
Company: Eisai (Japan) Arena Pharmaceuticals (USA - CA)
Product: Belviq® (lorcaserin HCl) and phentermine HCl
Action mechanism:
Disease: chronic weight management
Therapeutic area: Metabolic diseases
Country:
Trial
details: The randomized, double-blind pilot study of 12-weeks duration in overweight and obese adults evaluated whether short-term treatment with lorcaserin 10 mg twice daily (BID) plus two doses of immediate-release phentermine, 15 mg once daily (QD) or 15 mg BID, is associated with exacerbation of potential serotonergic adverse events compared to lorcaserin alone. In the trial, 238 subjects were randomized to one of the three treatment arms in a 1:1:1 ratio and received standardized weight-loss counseling during the trial.
Latest
news: * On October 28, 2014, Eisai and Arena Pharmaceuticals announced top-line results of a pilot study to assess the safety of lorcaserin HCl, a serotonin 2C receptor agonist, when coadministered with phentermine HCl. The results of the investigational study demonstrate that the short-term combination of lorcaserin plus phentermine does not appear to be associated with an exacerbation in the proportion of pre-specified adverse events compared to therapy with lorcaserin alone. The coadministration of lorcaserin and phentermine for weight management is investigational. The efficacy and safety of coadministration of lorcaserin and other weight loss products such as phentermine have not been established. The primary endpoint of the trial assessed the proportion of subjects reporting at least one of nine common potential serotonergic adverse events (headache, dizziness, nausea, fatigue, dry mouth, diarrhea, vomiting, insomnia, and/or anxiety) from baseline to the end of treatment. As a safety study, the arms were compared based on descriptive statistics. The most common adverse events in the study overall were dry mouth, headache, constipation, fatigue and dizziness.
