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news.Eisai has released results which demonstrate that Lorcaserin, a potential treatment for the management of obesity, has helped obese and overweight patients with type 2 diabetes achieve weight loss in the one-year Bloom-DM Phase 3 clinical trial.
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The Bloom-DM study evaluated obese and overweight patients with type 2 diabetes who were randomised to Lorcaserin 10mg BID, Lorcaserin 10mg dosed once daily (QD) or placebo.
The three primary efficacy endpoints at week 52 were the proportion of patients who lose at least 5% of their baseline body weight; change from baseline in body weight; and the proportion of patients who lose at least 10% of their baseline body weight.
Using Modified Intent-to-Treat Last Observation Carried Forward (MITT-LOCF) analysis, Lorcaserin 10mg BID met the three primary efficacy endpoints by producing weight loss compared to placebo.
Bloom-DM also evaluated five families of secondary endpoints at week 52 which are glycemic, lipid, blood pressure, body composition, and Quality of Life (QOL).
Data from the first three families are available, and analysis of body composition and QOL are pending.
Reportedly, within the glycemic, lipid and blood pressure families, Lorcaserin patients achieved improvements relative to placebo in HbA1c and fasting glucose.
Additionally, Lorcaserin 10mg BID patients achieved a 0.9% reduction in HbA1c, compared to a 0.4% reduction for the placebo group.
Eisai said that these top-line results, which demonstrated that diabetic patients achieved weight loss and improved glycemic parameters, provide additional support for Lorcaserin’s benefit-risk profile.