Randomized study of the efficacy and safety of SUN11031 (synthetic human ghrelin) in cachexia associated with chronic obstructive pulmonary disease

SummaryBackground & aimsUp to 40% of patients with chronic obstructive pulmonary disease (COPD) manifest cachexia characterized by sustained loss of lean body mass (LBM) associated with protein catabolism, and reduced physical function. The aim of this study was to determine the effects of SUN11031 on body mass and physical performance in cachectic patients with COPD.MethodsInternational, multicenter, randomized trial (NCT 00698828) that measured change from baseline in distance walked on the 6 minute walk test (6MWT) after 12 weeks of treatment, results of the Short Physical Performance Battery (SPPB), handgrip strength, maximum inspiratory pressure (PImax), body mass, body composition, appetite and lung function.ResultsSUN11031 at 20 and 40 μg/kg twice daily (bid) resulted in rapid and significant increases in body weight (1.8 and 2.4 kg, respectively; P = 0.020 and P < 0.001, respectively) and clinically meaningful increase in LBM. SUN11031 did not result in improvement in measures of physical performance in the intent-to-treat (ITT) population as a whole. However, the combination of more severe cachexia with increased LBM was associated with improvement in outcome, particularly on the SPPB, in patients who received 40 μg/kg bid.ConclusionsSUN11031 was well-tolerated and resulted in increases in body weight and LBM. Improvement in physical performance was observed in patients with severe cachexia. Additional study is warranted.