Averaging up to 20% of weight loss, adults taking Tirzepatide had at least 25 fewer breathing interruptions each hour as they slept

Up to 50% of adults taking Tirzepatide no longer had symptoms associated with OSA after one year

UAE, January 13 2024 — The U.S. Food and Drug Administration (FDA) approved lately Tirzepatide, produced by Eli Lilly, as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Tirzepatide may help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder. It should be used with a reduced-calorie diet and increased physical activity.

“Too often, OSA is brushed off as ‘just snoring’ — but it’s far more than that”, said Julie Flygare, J.D., president and CEO of Project Sleep. “It’s important to understand OSA symptoms and know that treatments are available, including new options like Tirzepatide. We hope this will spark more meaningful conversations between patients and healthcare providers and ultimately lead to better health outcomes”.

OSA is asleep-related breathing disorder characterized by complete or partial collapses of the upper airway during sleep, which can lead to pauses in breathing (apnea) or shallow breathing (hypopnea) and a potential decrease in oxygen saturation and/or waking from sleep. One of the hallmarks of OSA is snoring, but fatigue, excessive daytime sleepiness and disrupted sleep are also key symptoms, making this serious condition easily overlooked.

“Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” said Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA. “Tirzepatide is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity. Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges.”

This approval was based on results from the SURMOUNT-OSA phase 3 clinical trials, which evaluated Tirzepatide (10 mg or 15 mg) for the treatment of moderate-to-severe OSA in adults with obesity, with and without positive airway pressure (PAP) therapy over the course of a year. Tirzepatide was about five times more effective than placebo in reducing breathing disruptions in adults not on PAP therapy, leading to 25 fewer breathing disruptions per hour with Tirzepatide and five with placebo. In adults on PAP therapy, Tirzepatide led to 29 fewer breathing disruptions per hour compared to six with placebo. After one year, 42% of adults on Tirzepatide and 50% of adults on Tirzepatide with PAP therapy experienced remission or mild,

non-symptomatic OSA, compared to 16% and 14% on placebo, respectively.

In addition to improved OSA symptoms, adults on Tirzepatide lost an average of 45 lbs (18%) of their body weight, while adults on Tirzepatide with PAP therapy lost an average of 50 lbs (20%) of their body weight, compared to 4 lbs (2%) and 6 lbs (2%) on placebo, respectively.

About SURMOUNT-OSA

SURMOUNT-OSA (NCT05412004) was a multi-center, randomized, double-blind, parallel, placebo-master protocol comparing the efficacy and safety of Tirzepatide® (tirzepatide) to placebo in adults living with moderate-to-severe obstructive sleep apnea (OSA) and obesity who were unable or unwilling to use positive airway pressure (PAP) therapy (Study 1) and those who were and planned to stay on PAP therapy during the duration of the trial (Study 2). Under a master protocol, the trials randomized 469 participants across the U.S., Australia, Brazil, China, Czechia, Germany, Japan, Mexico and Taiwan in a 1:1 ratio to receive Tirzepatide maximum tolerated dose (MTD) of 10 mg or 15 mg or placebo. The primary objective of both studies was to demonstrate that Tirzepatide is superior in change in apnea-hypopnea index (AHI) from baseline at 52 weeks as compared to placebo.

SURMOUNT-OSA utilized an MTD of 10 mg or 15 mg once-weekly. The starting dose of 2.5 mg Tirzepatide was increased by 2.5 mg every four weeks until maximum tolerated dose was achieved. Participants who tolerated 15 mg continued on 15 mg as their MTD. Participants who tolerated 10 mg but did not tolerate 15 mg continued on 10 mg as their MTD.

About Tirzepatide

Tirzepatide injection is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. It is also approved in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.

Tirzepatide is the first and only dual-activating GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) obesity medication. Tirzepatide tackles an underlying cause of excess weight. It reduces appetite and how much you eat.