Eisai has reported positive topline results from the Cardiovascular And Metabolic Effects of Lorcaserin In Overweight And Obese Patients (CAMELLIA) TIMI61 trial after meeting the study’s primary safety objective.
CAMELLIA-TIMI61 is an ongoing Phase IIIB/IV, double-blind, placebo-controlled, parallel-group trial evaluating the safety and efficacy of lorcaserin hydrochloride (BELVIQ) as a metabolic intervention on cardiovascular health in patient with high cardiovascular risk.
Conducted in partnership with Thrombolysis in Myocardial Infarction (TIMI) Study Group, the trial enrolled 12,000 obese and overweight adult patients with cardiovascular disease or type 2 diabetes mellitus (T2DM) with cardiovascular risk factors at more than 400 sites in eight countries, including the US.
Its primary safety objective includes the evaluation of incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction or stroke.
If the primary safety objective was met, the efficacy objective was to investigate the impact of lorcaserin on the incidence of MACE+, defined as MACE or hospitalisation due to unstable angina or heart failure, or any coronary revascularisation.
The trial’s secondary objectives are evaluation for the potential to delay or prevent conversion to T2DM in patients with pre-diabetes or no diabetes at baseline and improvement of glycemic control in T2DM patients.
The newly released results have shown that BELVIQ did not increase the incidence of cardiovascular events among the enrolled patients, as well as improved long-term weight loss compared to placebo.
The results also showed a reduction in conversion to T2DM in patients without diabetes, as well as an improvement in multiple cardiovascular risk factors such as blood pressure, lipids, blood glucose and renal function.
Based on these results, Eisai plans to have discussions with the US Food and Drug Administration (FDA) on the potential revision of the product label on BELVIQ, which was previously approved by the FDA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients.