The injection lowered obstructive sleep apnea severity by up to nearly two-thirds in obese adults, with and without PAP therapy, in two phase 3 trials.

RT’s Three Key Takeaways: 

  • Tirzepatide achieved a mean apnea-hypopnea index reduction of up to 63% (about 30 fewer events per hour), meeting all primary and key secondary endpoints in two phase 3 clinical trials.
  • The drug was effective in lowering the apnea-hypopnea index in patients who were and were not using positive airway pressure therapy over a 52-week treatment period.
  • In addition to improving sleep apnea symptoms, tirzepatide led to a mean body weight reduction of around 20% from baseline in the study participants. Based on these results Lilly plans to submit these data for global regulatory reviews.

Eli Lilly announced that its weight-loss drug Zepbound (tirzepatide) reduced the severity of obstructive sleep apnea (OSA) by up to 63% in adults with OSA and obesity, meeting all primary and key secondary endpoints in two phase 3 clinical trials.

The injection meaningfully improved sleep apnea symptoms in those with moderate-to-severe OSA and obesity with and without positive airway pressure (PAP) therapy in the SURMOUNT-OSA trials. 

Based on these results, Lilly plans to submit to the US Food and Drug Administration (FDA) and other global regulatory agencies beginning mid-year. The FDA approved Zepbound injection last November for chronic weight management in adults with obesity or overweight with at least one weight-related condition. Lilly received FDA Fast Track designation for moderate-to-severe OSA and obesity.

“OSA impacts 80 million adults in the US, with more than 20 million living with moderate-to-severe OSA. However, 85% of OSA cases go undiagnosed and therefore untreated,” says Jeff Emmick, MD, PhD, senior vice president of product development at Lilly, in a release. “Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease.”

SURMOUNT-OSA Study 1

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. 

For the efficacy estimandi, at 52 weeks, tirzepatide led to a mean apnea-hypopnea index (AHI) reduction from baseline of 27.4 events per hour compared to a mean AHI reduction from baseline of 4.8 events per hour for placebo. 

In key secondary outcomes, tirzepatide led to a mean AHI reduction from baseline of 55% compared to 5% 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

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 for the efficacy estimand, 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 events per hour for 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.

Weight Loss Observed Across the Studies

The weight loss observed at 52 weeks with tirzepatide (10 mg and 15 mg) across the two studies was nearly 20% in a patient population that was comprised of approximately 70% males, who are known to achieve less weight loss with incretin therapy than females.

Topline Results

SURMOUNT-OSA Study 1 – Participants Not on PAP Therapy
Efficacy Estimand Results
at 52 Weeks		Treatment-Regimen Estimand Results at 52 Weeks
Primary Endpoint – Change in AHI from Baseline
Tirzepatide*-27.4-25.3
Placebo-4.8-5.3
Secondary Endpoint – Percent Change in AHI from Baseline
Tirzepatide*-55.0 %-50.7 %
Placebo-5.0 %-3.0 %
Secondary Endpoint – Percent Change in Body Weight from Baseline
Tirzepatide*-18.1 %-17.7 %
Placebo-1.3 %-1.6 %
SURMOUNT-OSA Study 2 Participants Used PAP Therapy
Efficacy Estimand Results
at 52 Weeks		Treatment-Regimen EstimandResults at 52 Weeks
Primary Endpoint – Change in AHI from Baseline
Tirzepatide*-30.4-29.3
Placebo-6.0-5.5
Secondary Endpoint – Percent Change in AHI from Baseline
Tirzepatide*-62.8 %-58.7 %
Placebo-6.4 %-2.5 %
Secondary Endpoint – Percent Change in Body Weight from Baseline
Tirzepatide*-20.1 %-19.6 %
Placebo-2.3 %-2.3 %

The SURMOUNT-OSA trials will be presented during a symposium at the American Diabetes Association’s 84th Scientific Sessions on June 21 at 3:45 pm ET and submitted to a peer-reviewed journal. 

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