Benzinga - by Vandana Singh, Benzinga Editor.
Wednesday, Eli Lilly And Co (NYSE:LLY) released topline results from SURMOUNT-OSA phase 3 trials of tirzepatide in obstructive sleep apnea (OSA), a sleep-related breathing disorder characterized by complete or partial collapses of the upper airway during sleep.
The data showed that tirzepatide significantly reduced the apnea-hypopnea index (AHI) compared to placebo, achieving the primary endpoints. Percentage change in AHI was a key secondary endpoint in both studies.
Also Read: Eli Lilly Suffers Legal Loss For Its Popular Weight Loss/Diabetes Drug In Lawsuit Against Florida Compounding Pharmacy.
AHI records the number of times a person’s breathing shows a restricted or complete block of airflow per hour of sleep.
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.
- Tirzepatide injection led to a mean AHI reduction of 27.4 events per hour from baseline compared to a mean AHI reduction of 4.8 events per hour for placebo.
- In key secondary outcomes, Tirzepatide led to a mean AHI reduction from baseline of 55.0% compared to 5.0% from baseline for placebo.
- Tirzepatide also led to a mean body weight reduction of 18.1% from baseline, compared to 1.3% from baseline for placebo.
- In this population, at 52 weeks, tirzepatide led to a mean AHI reduction from baseline of 30.4 events per hour compared to a mean AHI reduction from baseline of 6.0 events per hour for the placebo.
- In key secondary outcomes, tirzepatide led to a mean AHI reduction from baseline of 62.8% compared to 6.4% from baseline for placebo.
- Tirzepatide also led to a mean body weight reduction of 20.1% from baseline, compared to 2.3% from baseline for placebo.
Lilly plans to submit to the FDA and other global regulatory agencies beginning mid-year.
Price Action: LLY shares are up 2.58% at $766 during the premarket session on the last check Wednesday.
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