Long Term Extension trial of RM-493 patients in genetic obesity

• Research type

  Research Study

• Full title

  Long Term Extension Trial of setmelanotide (RM-493) for patients who have completed a trial of Setmelanotide for the treatment of obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway

• IRAS ID

  256608

• Contact name

  Sadaf Farooqi

• Contact email

  isf20@cam.ac.uk

• Sponsor organisation

  Rhythm Pharmaceuticals, Inc.

• Eudract number

  2017-005006-35

• Duration of Study in the UK

  2 years, 10 months, 13 days

• Research summary

  This purpose of this study is to continue the assessment of patients who have successfully completed a prior clinical study involving the IMP (Setmelanotide). The IMP is designed for the treatment of obesity associated with genetic defects patients with genetic deficiencies that cause obesity. \n\nThe Primary objective of this open label extension study is to explore the long term safety and tolerability of the IMP for up to 2 years or until the IMP is available through authorised use.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  19/SW/0005

• Date of REC Opinion

  31 Mar 2019

• REC opinion

  Further Information Favourable Opinion