Key facts

Drug
tirzepatide
Design
Randomized controlled trial
Participants
469
Duration
52 weeks
Funding
Eli Lilly
Registry
NCT05412004
Population
469 adults with moderate or severe obstructive sleep apnea and obesity (BMI of 30 or more; 27 or more in Japan), without diabetes, in two parallel trials: trial 1 with 234 people who were not using positive airway pressure (PAP, such as CPAP) and trial 2 with 235 who were. Mean baseline apnea-hypopnea index was 51.5 and 49.5 events per hour, and mean BMI was 39.1 and 38.7.
Primary outcome
Change in the apnea-hypopnea index (AHI, the number of apneas and hypopneas per hour of sleep) from baseline to week 52 with the maximum tolerated dose of tirzepatide (10 or 15 mg once weekly) versus placebo.

What it found

At 52 weeks, the AHI fell by 25.3 events per hour with tirzepatide and 5.3 with placebo in trial 1 (difference of −20.0; 95% CI, −25.8 to −14.2), and by 29.3 versus 5.5 in trial 2 (difference of −23.8; 95% CI, −29.6 to −17.9). Weight changed by −17.7% versus −1.6% in trial 1 (difference of −16.1 percentage points; 95% CI, −18.0 to −14.2) and by −19.6% versus −2.3% in trial 2 (difference of −17.3 points; 95% CI, −19.3 to −15.3). Hypoxic burden, C-reactive protein, systolic blood pressure and participant-reported sleep impairment also improved versus placebo. The most common adverse effects with tirzepatide were digestive, mostly mild or moderate.

Limitations

Funded by Eli Lilly; the statistical analyses were done by employees of the sponsor. At 52 weeks, it cannot assess long-term cardiovascular outcomes. It only included people with obesity and without diabetes. Trial 2 was not designed to find out whether the drug changes CPAP use. The trial was completed by 91.5% of participants on tirzepatide and 74.4% on placebo.

What it means for you

In people with obesity and moderate or severe obstructive sleep apnea, tirzepatide (Zepbound) reduced apneas and hypopneas by an average of 25 to 29 per hour of sleep, compared with about 5 on placebo. The trial did not assess whether it allows people to stop using CPAP. If you have sleep apnea, any change to its treatment should be discussed with your doctor or sleep clinic.

Further reading

Sources

The original paper and the records consulted for this summary, with the date they were accessed.

  1. New England Journal of Medicine.Malhotra A, et al. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. N Engl J Med. 2024;391(13):1193-1205.accessed .
  2. National Library of Medicine (PubMed).PubMed record PMID 38912654 (abstract).accessed .
  3. PubMed Central (National Library of Medicine).Full text PMC11598664 (author manuscript: participants, weight results, limitations, funding).accessed .