Eli Lilly and Company (LLY) Wednesday said its SURMOUNT-OSA phase 3 studies of tirzepatide in people with obstructive sleep apnea (OSA) and obesity reached their primary goals.
OSA is a sleep-related breathing disorder in which breathing stops for brief periods of time during sleep. OSA can cause serious health problems including heart disease, stroke, diabetes etc.
SURMOUNT-OSA Study 1 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were not on positive airway pressure (PAP) therapy for 52 weeks. SURMOUNT-OSA Study 2 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were on PAP therapy for 52 weeks.
In both the studies, tirzepatide reduced sleep apnea severity by up to nearly two-third, compared to placebo, achieving the primary endpoints. The overall safety profile of tirzepatide in SURMOUNT-OSA studies was similar to previously reported SURMOUNT and SURPASS trials.
Lilly said it plans to submit these data for FDA and other global regulatory reviews beginning mid-year.
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