ATX-101 vs. placebo for submental fat reduction (ATX-101-10-17)

• Research type

  Research Study

• Full title

  Phase 3, multicentre, randomised, double-blind, placebo-controlled study of ATX-101 (sodium deoxycholate injection) versus placebo for the reduction of localised subcutaneous fat in the submental area

• IRAS ID

  60869

• Contact name

  Steven Jeffery

• Sponsor organisation

  Kythera Biopharmaceuticals, Ltd.

• Eudract number

  2010-020691-28

• ISRCTN Number

  N/A

• Research summary

  The investigational medicinal product tested in this study is coded as ATX-101. ATX-101 is an injectable drug that is being developed for reduction of fat deposits in the area under the chin. Fat accumulation under the chin can often occur in individuals who are not overweight and can be resistant to weight reduction measures. This is a Phase 3 multicentre, randomised (each subject will receive treatment in a random fashion), double-blind (neither the subject nor the study staff will know which treatments are being received), placebo-controlled (inactive treatment that serves as a control) study of the safety and efficacy of ATX-101 for reduction of fat deposits in the area under the chin. ATX-101 will be studied at two dose concentrations relative to placebo (control). ATX-101 is administered through multiple subcutaneous injections on a grid in the submental area in monthly treatment sessions. Safety will be assessed by spontaneous adverse events, clinical evaluation and laboratory test results. Efficacy of the drug in chin reduction will be evaluated through a battery of subjective and objective assessments.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  10/H1211/54

• Date of REC Opinion

  24 Jan 2011

• REC opinion

  Further Information Favourable Opinion