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Drug maker must restart obesity drug study after releasing early data

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2844 (Published 22 May 2015) Cite this as: BMJ 2015;350:h2844
  1. Owen Dyer
  1. 1Montreal

A major US study of a newly approved antiobesity drug that was designed to measure adverse cardiovascular effects has been stopped by its steering committee after the manufacturer revealed first quarter data in a patent application.

After the release by the manufacturers, Steven Nissen of the Cleveland Clinic, lead investigator in the Light trial, which compared the antiobesity drug Contrave (a combination of naltrexone and bupropion) with placebo in over 8900 overweight subjects, then released data from the trial’s halfway mark against the wishes of Contrave’s manufacturer, Orexigen Therapeutics. The more complete data seemed to squash hopes of a surprise cardiovascular safety benefit suggested by the first quarter data.

“Patients were misled, investors were misled,” Nissen told Forbes, adding that Orexigen had breached the data access …

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