A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.

Timeline

Start

2014-01-24

Primary completion

2018-05-14

Completion

2018-05-14

Outcome

Mixed primary results

registry analysis (non-inferiority test); Placebo vs Lorcaserin 10 mg; p = 0.0001; Hazard Ratio (HR) 1.005 (97.5% CI 0.842 to 1.198); Primary Analytic Method NCT02019264 ↗

registry analysis (superiority test); Placebo vs Lorcaserin 10 mg; p = 0.5464; Hazard Ratio (HR) 0.969 (95% CI 0.873 to 1.074); Primary Analytic Method NCT02019264 ↗

Publications

• Scirica BM, Bohula EA, Dwyer JP, Qamar A, Inzucchi SE, McGuire DK, Keech AC, Smith SR, Murphy SA, Im K, Leiter LA, Gupta M, Patel T, Miao W, Perdomo C, Bonaca MP, Ruff CT, Sabatine MS, Wiviott SD; CAMELLIA-TIMI 61 Steering Committee and Investigators. Lorcaserin and Renal Outcomes in Obese and Overweight Patients in the CAMELLIA-TIMI 61 Trial. Circulation. 2019 Jan 15;139(3):366-375. doi: 10.1161/CIRCULATIONAHA.118.038341.
• Bohula EA, Scirica BM, Inzucchi SE, McGuire DK, Keech AC, Smith SR, Kanevsky E, Murphy SA, Leiter LA, Dwyer JP, Corbalan R, Hamm C, Kaplan L, Nicolau JC, Ophuis TO, Ray KK, Ruda M, Spinar J, Patel T, Miao W, Perdomo C, Francis B, Dhadda S, Bonaca MP, Ruff CT, Sabatine MS, Wiviott SD; CAMELLIA-TIMI 61 Steering Committee Investigators. Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial. Lancet. 2018 Nov 24;392(10161):2269-2279. doi: 10.1016/S0140-6736(18)32328-6. Epub 2018 Oct 4.
• Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, Fanola CL, Qamar A, Brown C, Budaj A, Garcia-Castillo A, Gupta M, Leiter LA, Weissman NJ, White HD, Patel T, Francis B, Miao W, Perdomo C, Dhadda S, Bonaca MP, Ruff CT, Keech AC, Smith SR, Sabatine MS, Scirica BM; CAMELLIA-TIMI 61 Steering Committee and Investigators. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. N Engl J Med. 2018 Sep 20;379(12):1107-1117. doi: 10.1056/NEJMoa1808721. Epub 2018 Aug 26.
• Bohula EA, Scirica BM, Fanola C, Inzucchi SE, Keech A, McGuire DK, Smith SR, Abrahamsen T, Francis BH, Miao W, Perdomo CA, Satlin A, Wiviott SD, Sabatine MS. Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial. Am Heart J. 2018 Aug;202:39-48. doi: 10.1016/j.ahj.2018.03.012. Epub 2018 Mar 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lorcaserin	Small molecule	10 mg	—

Indications