Dataset from A Randomized, 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

Impaired physical function and muscle dysfunction are a major consequence of COPD, which may
be associated with increased mortality, poor quality of life and increased health care use.
This is a randomized, placebo-controlled, double-blind, parallel group study to evaluate the
safety and tolerability of GSK2881078, an SARM over 13 weeks of dosing in older male subjects
and post-menopausal female subjects with COPD and muscle weakness. This study will also
assess the effect of GSK2881078 on physical strength and function after 13 weeks of
treatment. Approximately 100 subjects with COPD and muscle weakness will be randomized into
two cohorts of 50 male subjects and 50 female subjects. Within each cohort, subjects will be
randomized to receive GSK2881078 or placebo in a ratio of 1:1. All subjects will participate
in a standardized home exercise program, which will consist of daily walking, along with
several resistance or weight-bearing exercises, such as bicep curls, upright rows, step ups
and a sit-to-stand maneuver. The study will consist of a screening/Baseline period of up to
30 days, a 13-week treatment period and a post-treatment follow-up period of 6 weeks.