Study to evaluate the safety & efficacy of 13 weeks of SARM GSK2881078

• Research type

  Research Study

• Full title

  A randomised, double-blind (sponsor unblind), placebo-controlled, multi-centred phase IIa study to evaluate the safety and efficacy of 13 weeks of once daily oral dosing of the selective androgen receptor modulator (SARM) GSK2881078 in older men and post menopausal women with COPD and muscle weakness, participating in home exercise

• IRAS ID

  235968

• Contact name

  Holly Spencer

• Contact email

  holly.spencer@parexel.com

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2017-001148-37

• Clinicaltrials.gov Identifier

  NCT03359473

• Duration of Study in the UK

  0 years, 8 months, 1 days

• Research summary

  Reduced locomotor muscle function and, consequently exercise limitation and reduced physical activity, affects the daily lives of many people with COPD. Physical exercise, for example as a component of pulmonary rehabilitation programmes, have been shown to increase muscle mass and improve physical activity in people with COPD, but not all people with COPD are able to access or start these programmes, and the benefits in any case tend to wane after approximately a year.
  
  There is thus an unmet need for a safe and effective medicine which could do the same thing, but currently, there are no approved therapies for this purpose for COPD patients.
  
  GSK2881078, the study drug, belongs to a new class of drugs called non-steroidal, selective androgen receptor modulators (SARMs), which can mimic some of the beneficial effects of testosterone whilst avoiding some of the unwanted side effects.

  The purpose of this study is to test the safety of GSK2881078 (study drug) in men and women with COPD and muscle weakness. The study will check the effects of GSK2881078 on muscle assessed as changes in leg strength, muscle mass, and functional measures such as walking capacity.
  
  The study drug, GSK2881078, is not yet approved by the regulatory authorities (such as the Food and Drug Administration), for any indication
  
  Approximately 100 people in 3 countries will take part in this study.
  
  GlaxoSmithKline (also called “GSK”) is a pharmaceutical company that is sponsoring the study.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  18/EE/0092

• Date of REC Opinion

  25 May 2018

• REC opinion

  Further Information Favourable Opinion