The double-blind, randomised study is being conducted under a cooperative research and development agreement between Aeterna Zentaris and the Michael E. DeBakey Veterans Affairs Medical Center.
The study will test the effects of different doses of AEZS-130 in 18 to 26 patients with cancer-cachexia.
Aeterna Zentaris president and CEO Juergen Engel said, "Because cachexia is very common among cancer patients, our oral ghrelin agonist, AEZS-130, could represent a novel treatment option for many of the 1.5 million people diagnosed with cancer each year, in the US alone."
Following the safety and efficacy analysis at each dose level vs. placebo in the study, which involves three sequential groups receiving differing doses of AEZS-130, the decision to either decrease or increase the dose will be taken.
The adequate efficacy in the study is defined as a =0.8kg of body weight gain or a =50ng/mL increase in plasma IGF-1 levels.
The safety and efficacy of repeated oral administration of AEZS-130 at different doses daily for one week in view of developing a treatment for cachexia is the primary objective of the placebo-controlled study.
Other secondary objectives include food intake, and changes in the appetite, muscle strength, energy expenditure, reward from food and functional brain connectivity, according to the company.