By: Jill Stein

SAN DIEGO, CA – The selective small-molecule agonist of the serotonin 2C (5-HT2C) receptor lorcaserin leads to significant weight loss and boosts glycaemic control in overweight and obese patients with type 2 diabetes, according to data presented at the 71st Annual Scientific Sessions of the American Diabetes Association.

Patrick O’Neil, PhD, Medical University of South Carolina, Charleston, South Carolina, and colleagues presented results from 509 patients who had been randomised to lorcaserin 10 mg BID, lorcaserin 10 mg QD, or placebo as part of the phase 3 Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus (BLOOM-DM) study.

All patients had type 2 diabetes that was inadequately controlled with metformin and/or a sulphonylurea, and they had a body mass index of 27 to 45 kg/m2.

Enrolment in the 10-mg QD group was halted prematurely to speed up completion of the trial, and results in the 95 patients in this group were not presented.

The primary endpoints at week 52 were the percentage of patients with ≥5% weight loss, the absolute change in body weight, and the percentage of patients with ≥10% weight loss.

Overall, 66% of the 256 lorcaserin-treated patients and 62% of the 253 placebo-treated patients completed the trial.

At week 52, in the modified intent-to-treat with last observation carried forward, 37.5% of the lorcaserin cohort and 16.1% of the placebo cohort, respectively, achieved ≥5% weight loss (P <.001), and 16.3 and 4.4%, respectively, achieved ≥10% weight loss (P <.001).

Least-squares mean weight loss in the lorcaserin arm was 4.5% compared with 1.5% in the placebo group (P <.001).

Significant improvements (least-squares mean - SE) over placebo were also observed for haemoglobin A1C, fasting glucose, and Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR). Blood pressure did not change significantly in either group.

Lorcaserin was generally well tolerated, and the most common adverse event was headache.

Overall, the results show that lorcaserin treatment of overweight/obese type 2 diabetic patients on metformin and/or a sulphonylurea produced a significantly greatly weight loss than placebo, significant reductions in anthropometric measures associated with excess body weight, and significantly larger improvements in glycaemic control with good tolerability.

Funding for the study was provided by Arena Pharmaceuticals.

- MFP Wire Services
- 07-04-2011