NCT00698828

SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2b, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SUN11031 for Injection Administered Subcutaneously Twice Daily for 12 Weeks to Subjects Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cachexia

Interventions

Type	Name	Description
DRUG	Placebo comparator	Twice daily subcutaneous injections of placebo for 12 weeks.
DRUG	SUN11031 20 μg/kg	Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks.
DRUG	SUN11031 40 μg/kg	Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.

Timeline

• Start date: 2008-05-15
• Primary completion: 2009-10-08
• Completion: 2009-10-08
• First posted: 2008-06-17
• Last updated: 2021-01-28
• Results posted: 2021-01-28

Locations

43 sites across 6 countries: United States, Argentina, Chile, Guatemala, Honduras, Romania

Regulatory

• FDA-regulated drug study