Conditions: Cachexia
Keywords: Cachexia, COPD, Chronic Obstructive Pulmonary Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 227
Healthy volunteers: no

Brief summary:
To evaluate SUN11031 for subcutaneous injection compared to placebo in subjects with cachexia associated with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical performance and body composition.

Detailed description:

Arms:
arm 1: SUN11031 for injection, low dose, twice daily for 12 weeks arm 2: SUN11031 for injection, higher dose, twice daily for 12 weeks arm 3: Placebo injection, twice daily for 12 weeks

Interventions: intervention 1: Placebo comparator intervention 2: SUN11031 20 μg/kg intervention 3: SUN11031 40 μg/kg
Intervention descriptions: intervention 1: Twice daily subcutaneous injections of placebo for 12 weeks. intervention 2: Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks. intervention 3: Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.

Protocol document: