Tirzepatide Shows Benefit in Obstructive Sleep Apnea, SURMOUNT-OSA Trial

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Topline data from the SURMOUNT-OSA studies provide insight into the effects of tirzepatide in OSA with obesity, with Lilly disclosing plans for a regulatory submission mid-year.

Close up of a scale depicting body weight. | Credit: iStock

Credit: iStock

Eli Lilly and Company has announced topline results from their phase 3 SURMOUNT-OSA clinical trial program, with data indicating use of tirzepatide (Zepbound), in both the 10 mg or 15 mg dose, significantly reduced apnea-hypopnea index (AHI) relative to placebo therapy—paving the way for the company to submit a mid-year application for approval in moderate-to-severe obstructive sleep apnea (OSA) and obesity.

A combination of 2 studies examining tirzepatide in adults with OSA, results indicate use of tirzepatide reduced AHI in patients with OSA, with this benefit observed regardless of positive airway pressure (PAP) therapy. Further analysis of both studies demonstrated tirzepatide provided benefit for secondary outcomes, including mean AHI percentage reduction and body weight reduction from baseline to week 52.1

"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,” said Jeff Emmick, MD, PhD, senior vice president, product development at Eli Lilly and Company.1

Although the terms Ozempic and Wegovy have grown to become household names in the last half-decade, much of the excitement surrounding GLP-1-based therapies from the frontlines of care and research came as a result of the therapeutic pipeline for incretin therapies beyond semaglutide, namely tirzepatide.2

The agent’s unofficial introduction to many came in the form of the SURPASS program, which examined the dual GIP/GLP-1 receptor agonist for type 2 diabetes. Excitement surrounding the agent reached a fever pitch, which has yet to subside, with the presentation of SURMOUNT-1 brought forth evidence of the weight loss achieved with this therapy. Since the trials from these programs were initially published, tirzepatide has received approvals from the US FDA as an adjunct therapy for improving glycemic control in adults with type 2 diabetes (Mounjaro) as well as for chronic weight management in adults with obesity or overweight with at least 1 weight-related condition in addition to a reduced calorie diet and increased physical activity (Zepbound).3,4,5,6

SURMOUNT-OSA was a multi-center, randomized, double-blind, parallel, placebo-master protocol trial consisting of 2 studies with a total population of 469 participants from 9 countries across 5 continents. SURMOUNT-OSA Study 1 enrolled adults living with moderate-to-severe OSA and obesity unable or unwilling to use PAP therapy. SURMOUNT-OSA Study 2 adults with OSA and obesity who were and planned to stay on PAP therapy during the duration of the trial.1

The primary outcome of interest for both studies was change in AHI from baseline to week 52. The trial’s secondary outcomes of interest were percent change in AHI from baseline and percent change in body weight from baseline. Of note, the starting dose of each trial was 2.5 mg tirzepatide, which was increased by 2.5 mg every 4 weeks until a maximum tolerated dose of 10 or 15 mg once-weekly was achieved.1

Analysis of SURMOUNT-OSA Study 1 indicated use of tirzepatide was associated with a mean AHI reduction of 27.4 events per hour from baseline to 52 weeks compared to a mean AHI reduction of 4.8 events per hour with placebo therapy in the efficacy estimand. Secondary outcomes analysis suggested use of tirzepatide was associated with greater reductions in mean AHI (55.0% vs 5.0%) and mean body weight (18.1% vs 1.3%) than placebo therapy from baseline to 52 weeks.1

Results of SURMOUNT-OSA Study 2 indicated use of tirzepatide was associated with a mean AHI reduction of 30.4 events per hour from baseline to 52 weeks compared to a mean AHI reduction of 6.0 events per hour with placebo therapy in the efficacy estimand. Secondary outcomes analysis suggested use of tirzepatide was associated with greater reductions in mean AHI (62.8% vs 6.4%) and mean body weight (20.3% vs 2.3%) than placebo therapy from baseline to 52 weeks.1

Analysis of safety from the SURMOUNT-OSA studies suggested the observed safety profile was similar to the safety profile reported in the SURMOUNT and SURPASS trials. According to their release announcing topline results, Eli Lilly and Company plans to present full data from SURMOUNT-OSA at the American Diabetes Association's 84th Scientific Sessions.1

For more on tirzepatide, check out this recent episode of HCPLive’s flagship endocrinology podcast Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives with W. Timothy Garvey, MD, principal investigator of SURMOUNT-2 and director of the Diabetes Research Center at the University of Alabama at Birmingham.

References:

  1. Eli Lilly and Company. Tirzepatide reduced sleep apnea severity by up to nearly two-thirds in adults with obstructive sleep apnea (OSA) and Obesity. Eli Lilly and Company. April 17, 2024. Accessed April 17, 2024. https://investor.lilly.com/news-releases/news-release-details/tirzepatide-reduced-sleep-apnea-severity-nearly-two-thirds.
  2. Campbell P, Iapoce C. 10 years of obesity: A Decade of Advancement and challenges. HCP Live. June 23, 2023. Accessed April 17, 2024. https://www.hcplive.com/view/10-years-of-obesity-a-decade-of-advancement-and-challenges.
  3. Campbell P. Ada 2021: Tirzepatide demonstrates potential in type 2 diabetes with surpass trials. HCP Live. June 29, 2021. Accessed April 17, 2024. https://www.hcplive.com/view/ada-2021-tirzepatide-demonstrates-potential-in-type-2-diabetes-with-surpass-trials.
  4. Campbell P. Surmount-1 results tout tirzepatide’s weight loss benefits. HCP Live. April 28, 2022. Accessed April 17, 2024. https://www.hcplive.com/view/surmount-1-results-tout-tirzepatide-s-weight-loss-benefits.
  5. Campbell P. Tirzepatide (Mounjaro) wins FDA approval for type 2 diabetes. HCP Live. May 13, 2022. Accessed April 17, 2024. https://www.hcplive.com/view/tirzepatide-wins-fda-approval-for-type-2-diabetes.
  6. Campbell P. FDA approves Tirzepatide (Zepbound) for Chronic Weight Management. HCP Live. November 8, 2023. Accessed April 17, 2024. https://www.hcplive.com/view/fda-approves-tirzepatide-zepbound-chronic-weight-management.
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