The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Kentucky Research Group
Louisville, Kentucky, United States
Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.
AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep
Time frame: between baseline and Week 28
Percent Change in Weight From Baseline to Week 28
Time frame: baseline to week 28
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