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# Lilly Filing NDA for Expanded Tirzepatide Use
- URL: https://www.fdaweb.com/lilly-filing-nda-for-expanded-tirzepatide-use/
- Published: 2024-04-17T12:00:00.000Z
- Updated: 2026-09-14T14:28:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156791

Eli Lilly says it will file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea (OSA) based on just-announced data from the SURMOUNT-OSA Phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo. Tirzepatide is the active ingredient in the company’s Zepbound for treating chronic weight management.

AHI records the number of times a person’s breathing shows a restricted or complete block of airflow per hour of sleep and is used to evaluate OSA severity and treatment effectiveness, the [company says](https://investor.lilly.com/news-releases/news-release-details/tirzepatide-reduced-sleep-apnea-severity-nearly-two-thirds?ref=fdaweb.com). In the study, tirzepatide led to a mean AHI reduction from baseline of 27.4 events per hour compared to 4.8 events per hour for placebo-treated patients, it says. In a key secondary outcome, tirzepatide led to a mean body weight reduction of 18.1% from baseline, compared to 1.3% from baseline for placebo.

Lilly says tirzepatide’s overall safety profile was similar to previously reported trials, with the most commonly reported adverse events being gastrointestinal-related and generally mild to moderate in severity (diarrhea, nausea, vomiting and constipation).