- In the primary endpoint, tirzepatide reduced
moderate-to-severe OSA severity by up to 62.8% (about 30 fewer
events per hour)
- In a key secondary endpoint from two clinical studies, 43.0%
and 51.5% of participants taking tirzepatide at the highest dose
reached the criteria for disease resolution as defined by
apnea-hypopnea index and Epworth Sleepiness Scale measures
- Lilly submitted tirzepatide for the treatment of
moderate-to-severe OSA to the U.S. Food and Drug Administration
(FDA) and will initiate submissions for other global regulatory
agencies in the coming weeks
TORONTO, June 24,
2024 /CNW/ - Lilly
Canada announced detailed results from the SURMOUNT-OSA
phase 3 clinical trials evaluating tirzepatide injection (10 mg or
15 mg) for the treatment of moderate-to-severe obstructive sleep
apnea (OSA) in adults with obesity, with and without positive
airway pressure (PAP) therapy. In both studies, tirzepatide
achieved all primary and key secondary endpoints for both the
efficacyi and treatment-regimenii estimands
and demonstrated a mean reduction of up to 62.8% on the
apnea-hypopnea index (AHI), or about 30 fewer events restricting or
blocking a person's airflow per hour of sleep, compared to placebo.
Full results were published in The New England Journal of
Medicine (NEJM) and presented at the American Diabetes
Association® (ADA) 84th Scientific
Sessions.
![Eli Lilly Canada Inc. (CNW Group/Eli Lilly Canada Inc.) Eli Lilly Canada Inc. (CNW Group/Eli Lilly Canada Inc.)](https://mma.prnewswire.com/media/2446451/Eli_Lilly_Canada_Inc__LILLY_S_TIRZEPATIDE_REDUCED_OBSTRUCTIVE_SL.jpg)
In a key secondary endpoint, the efficacy estimand showed that
43.0% (Study 1) and 51.5% (Study 2) of participants treated with
tirzepatide at the highest dose met the criteria for disease
resolution. In this context, "disease resolution" means achieving
an AHI of fewer than 5 events per hour, or an AHI of 5-14 events
per hour and an Epworth Sleepiness Scale (ESS) score of ≤10. ESS is
a standard questionnaire designed to assess excessive daytime
sleepiness.1-4
OSA is a complex disease that can impact the progression of
serious cardiometabolic complications, including hypertension,
coronary heart disease, stroke, heart failure, atrial fibrillation
and type 2 diabetes.5 Participants treated with
tirzepatide in both studies experienced significant improvements in
all key secondary endpoints including systolic blood pressure,
hypoxic burden, and high-sensitivity C-reactive protein (hsCRP), an
inflammation marker, compared to placebo.
"Obstructive sleep apnea is a very common, under recognized
disease. When untreated, it can lead to many serious adverse health
impacts." says Dr. Najib Ayas Professor of Medicine, University of British Columbia. "The SURMOUNT-OSA
phase 3 clinical trial data is compelling as the majority of
patients treated with tirzepatide experienced 30 fewer disruptive
events every hour of sleep and nearly half achieved disease
resolution. This is an important study and provides a potential new
tool to treat adults living with moderate-to-severe OSA which is
greatly needed."
Full 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 –
Percentage of Participants with AHI <5 or AHI 5-14 with ESS
≤10
|
Tirzepatide*
|
43.0 %
|
42.2 %
|
Placebo
|
14.9 %
|
15.9 %
|
Secondary Endpoint –
Percentage of Participants with ≥50% AHI
Reduction
|
Tirzepatide*
|
62.3 %
|
61.2 %
|
Placebo
|
19.2 %
|
19 %
|
Secondary Endpoint –
Percent Change in Body Weight
|
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
Estimand Results 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 –
Percentage of Participants with AHI <5 or AHI 5-14 with ESS
≤10
|
Tirzepatide*
|
51.5 %
|
50.2 %
|
Placebo
|
13.6 %
|
14.3 %
|
Secondary Endpoint –
Percentage of Participants with ≥50% AHI
Reduction
|
Tirzepatide*
|
74.3 %
|
72.4 %
|
Placebo
|
22.9 %
|
23.3 %
|
Secondary Endpoint –
Percent Change in Body Weight
|
Tirzepatide*
|
-20.1 %
|
-19.6 %
|
Placebo
|
-2.3 %
|
-2.3 %
|
*For both SURMOUNT-OSA study 1 and study 2, Tirzepatide
MTD is maximum tolerated dose 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 maximum tolerated
dose. Participants who tolerated 10 mg but did not tolerate 15 mg
continued on 10 mg as their maximum tolerated dose.
"One in five Canadians are impacted by obstructive sleep apnea
(OSA) and this complex disease is linked to very serious health
complications," says Dr. Sandy
Henderson, Vice President, Medical Director, Lilly Canada. "Tirzepatide demonstrated that
patients with moderate-to-severe OSA with obesity were able to
achieve OSA disease resolution based on predetermined AHI and ESS
measures. The SURMOUNT-OSA data is promising and provides a
potential new treatment option for some patients with OSA."
The overall safety profile of tirzepatide in SURMOUNT-OSA
studies was similar to previously reported SURMOUNT and SURPASS
trials. The most commonly reported adverse events in SURMOUNT-OSA
were gastrointestinal related and generally mild to moderate in
severity. The most frequent events reported by those on tirzepatide
compared with placebo, respectively, were diarrhea (26.3% vs
12.5%), nausea (25.4% vs 10.0%) and vomiting (17.5% vs 4.2%) in
SURMOUNT-OSA Study 1, and diarrhea (21.8% vs 8.8%), nausea (21.8%
vs 5.3%) and constipation (15.1% vs 4.4%) in SURMOUNT-OSA Study 2.
Adverse events led to discontinuation of study treatment in 9
participants taking tirzepatide (5 in Study 1 and 4 in Study 2) and
10 taking placebo (2 in Study 1 and 8 in Study 2).
Tirzepatide is the only approved GIP (glucose-dependent
insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1)
treatment for chronic weight management, commercialized as
Zepbound® in the U.S. and Mounjaro® in some
global markets outside the US. Tirzepatide for the treatment of
moderate-to-severe OSA in adults with obesity was submitted to the
U.S. Food and Drug Administration (FDA) with potential approval
anticipated later this year. Lilly received FDA Fast Track
designation for moderate-to-severe OSA in patients with
obesity.
About SURMOUNT-OSA
SURMOUNT-OSA (NCT05412004) was a multi-centre, randomized,
double-blind, parallel, placebo-master protocol comparing the
efficacy and safety of tirzepatide to placebo in adults living with
moderate-to-severe obstructive sleep apnea 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) 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 a 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 tirzepatide10
Tirzepatide is approved in Canada as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes
mellitus.
About Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites
caring with discovery to make life better for people around the
world. We were founded more than a century ago by Colonel Eli
Lilly, who was committed to creating high quality medicines that
meet people's needs, and today we remain true to that mission in
all our work. Lilly employees work to discover and bring
life-changing medicines to people who need them, improve the
understanding and management of disease, and contribute to our
communities through philanthropy and volunteerism.
Eli Lilly Canada was established in 1938, the result of a
research collaboration with scientists at the University of Toronto which eventually produced the
world's first commercially available insulin. Our work focuses on
oncology, diabetes, autoimmunity, neurodegeneration, and pain. To
learn more about Lilly Canada,
please visit us at www.lilly.ca.
___________________________
|
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SOURCE Eli Lilly Canada Inc.