Clinical evaluation of medicinal products used in weight control - Scientific guideline

This guideline provides medicine developers guidance on the clinical evaluation of new medicinal products for promoting weight loss in obese adult patients. It clarifies the requirements for the clinical documentation needed to support a marketing authorisation of weight management medicines, including the recommended methods for assessing efficacy, selection of patients, strategy and design of clinical trials.

For guidance on clinical investigation of treatment of obesity in children, see the addendum to this guideline.

Keywords: Obesity, weight control

Revision 1 (Current effective version)

First version

This version was in effect from 31 May 2008 to 31 December 2016.