ADA24: Lilly's new data boost tirzepatide sleep apnoea goals

Eli Lilly's latest data further supports the case for expanding the use of tirzepatide, a popular GIP/GLP-1 receptor agonist, to treat moderate-to-severe obstructive sleep apnea (OSA) and obesity. The FDA is currently reviewing this potential new indication, with a decision expected by the end of the year. Detailed findings from the SURMOUNT-OSA trials were revealed at the American Diabetes Association (ADA) annual meeting.

The updated results provide a clearer understanding of tirzepatide's effectiveness in managing OSA. The SURMOUNT-OSA program includes two Phase III trials: Study 1, which involves patients who are not using positive airway pressure (PAP) therapy, and Study 2, which involves those who are using PAP therapy. In April, Lilly announced that tirzepatide had led to mean reductions in the apnea-hypopnea index (AHI) of 27.4 and 30.4 events per hour in Study 1 and Study 2, respectively. These reductions significantly outperformed the placebo, meeting the primary endpoints for both trials.

The latest data also shed light on several key secondary endpoints. In Study 1, 62.3% of participants on tirzepatide achieved an AHI reduction of at least 50%. Additionally, participants experienced an average body weight loss of 18.1%. The results were even more favorable in Study 2, where 74.3% of tirzepatide-treated participants achieved an AHI reduction of at least 50%, along with a 20.1% reduction in body weight.

Another critical measure was the rate of disease resolution. In Study 1, 43% of participants taking the highest dose of tirzepatide met the criteria for disease resolution. In Study 2, 51.5% of participants reached this milestone. Disease resolution was defined as achieving an AHI of fewer than 5 events per hour or an AHI of 5-14 events per hour along with a score of ≤10 on the Epworth Sleepiness Scale (ESS).

Kunal Gulati, executive director for diabetes and obesity medical affairs at Lilly Northern Europe, remarked that "tirzepatide has the potential to be the first pharmaceutical treatment for OSA, which could address the unmet need for people living with this condition."

Regarding safety, the most common adverse events reported in the SURMOUNT-OSA trials were generally mild-to-moderate gastrointestinal issues, including diarrhea, nausea, and vomiting. Lilly noted that these side effects were consistent with those observed in previous SURMOUNT and SURPASS trials. In both studies, adverse events led to the discontinuation of tirzepatide in nine participants, compared to ten participants who received a placebo.

In addition to the ongoing FDA review, Lilly has announced plans to submit applications to other global regulatory agencies in the coming weeks.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!