Arena starts phase 3 trial for weight loss drug lorcaserin

By E. Janene Geiss

Philadelphia, Sept. 12 - Arena Pharmaceuticals, Inc. announced Tuesday the dosing of the first patient in the first of three planned phase 3 clinical trials evaluating the efficacy and safety of its lead drug candidate, lorcaserin hydrochloride, for the treatment of obesity.

Known as Bloom (Behavioral modification and Lorcaserin for Overweight and Obesity Management), this double-blind, randomized and placebo-controlled trial will include about 100 centers in the United States and is expected to enroll about 3,000 overweight and obese patients.

The proportion of patients with a 5% or greater weight reduction is the primary endpoint, according to a news release from the San Diego biopharmaceutical company.

Phase 2b data showed that taking lorcaserin resulted in statistically significant, progressive and dose-dependent weight loss with a generally favorable tolerability profile. A review of the phase 3 trial's six-month echocardiographic data next summer will be a significant safety milestone that will trigger the beginning of additional phase 3 studies, officials said.

Lorcaserin is an orally administered compound that is selective in stimulating the 5-HT2C serotonin receptor, located in the hypothalamus, which helps regulate satiety and influences metabolic rate.

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