INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY) has reported positive outcomes from its phase 3 clinical trials of tirzepatide, indicating a significant reduction in the apnea-hypopnea index (AHI) in patients with moderate-to-severe obstructive sleep apnea (OSA) and obesity.
The trials, part of the SURMOUNT-OSA study, demonstrated that tirzepatide could decrease AHI by up to 63%, meeting both primary and key secondary endpoints.
The studies involved two groups of adults with OSA and obesity: those not using positive airway pressure (PAP) therapy and those continuing its use. Results at 52 weeks showed tirzepatide, administered in 10 mg or 15 mg doses, led to a mean AHI reduction from baseline of 27.4 events per hour without PAP therapy and 30.4 events per hour with PAP therapy. In comparison, placebo groups saw a mean reduction of 4.8 and 6.0 events per hour, respectively. Additionally, tirzepatide contributed to a mean body weight reduction of nearly 20% across both studies.
OSA, a disorder characterized by breathing interruptions during sleep, affects an estimated 80 million adults in the U.S., with a significant portion undiagnosed and untreated. Tirzepatide, currently approved for chronic weight management under the brand names Zepbound® in the U.S. and Mounjaro® in other markets, may become the first pharmaceutical treatment addressing the underlying disease of OSA, beyond the symptoms.
The safety profile of tirzepatide in the SURMOUNT-OSA studies was consistent with previous trials, with the most common adverse events being gastrointestinal-related and generally mild to moderate in severity.
Based on these findings, Lilly plans to submit the data for global regulatory reviews, aiming for mid-year submissions to the U.S. Food and Drug Administration (FDA) and other agencies. The company has already received FDA Fast Track designation for tirzepatide for moderate-to-severe OSA and obesity.
The full results of the SURMOUNT-OSA trials are scheduled for presentation at the American Diabetes Association's 84th Scientific Sessions on June 21 and will be submitted for peer-reviewed publication.
This article is based on a press release statement from Eli Lilly and Company.
InvestingPro Insights
Eli Lilly and Company (NYSE:LLY) has recently shown promising results from its SURMOUNT-OSA clinical trials, potentially positioning the pharmaceutical giant to further strengthen its market presence. The positive trial outcomes are timely as they coincide with a period of robust financial performance for the company, as reflected in several key metrics.
InvestingPro data indicates a solid revenue growth for Eli Lilly, with a 19.56% increase in revenue over the last twelve months as of Q4 2023. This growth is supported by a high gross profit margin of 79.25%, signifying the company's efficiency in managing its production costs and its ability to retain a significant portion of its sales as gross profit. Additionally, the company's operating income margin for the same period stands at a healthy 31.61%, further underscoring its operational effectiveness.
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