Wednesday, Eli Lilly And Co ( 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.

SURMOUNT-OSA Study 2 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were on and planned to continue to use PAP therapy for 52 weeks. 

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.

The weight loss observed at 52 weeks with tirzepatide (10 mg and 15 mg) across the two studies was nearly 20%.

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.