|
Eli Lilly and Company announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial. Zepbound (tirzepatide) provided a 47% greater relative weight loss compared to Wegovy (semaglutide). On average, Zepbound led to a superior weight loss of 20.2% compared to 13.7% with Wegovy. At 72 weeks, Zepbound beat Wegovy on both the primary endpoint and all five key secondary endpoints in this trial of adults living with obesity or overweight with at least one weight-related medical problem and without diabetes.
"Given the increased interest around obesity medications, we conducted this study to help health care providers and patients make informed decisions about treatment choice," said Leonard C. Glass, MD, FACE, senior vice president of global medical affairs at Lilly Cardiometabolic Health. "We are thrilled that today's findings showed the superior weight loss of Zepbound, which helped patients achieve 47% more relative weight loss compared to Wegovy. Zepbound is in a class of its own as the only FDA-approved dual GIP and GLP-1 receptor agonist obesity medication, and it's changing how millions of people manage this chronic disease."
In addition, in a key secondary endpoint, 31.6% of people taking Zepbound achieved at least 25% body weight loss compared to 16.1% of those taking Wegovy.
The overall safety profile of Zepbound in SURMOUNT-5 was similar to previously reported SURMOUNT trials. The most commonly reported adverse events in SURMOUNT-5 for both Zepbound and Wegovy were gastrointestinal-related and were generally mild to moderate in severity.
Lilly will continue to evaluate the SURMOUNT-5 results, which will be published in a peer-reviewed journal and presented at a medical meeting next year. Tirzepatide is commercialized for adults with obesity or with overweight who also have weight-related medical problems as Zepbound in the US and Mounjaro in some global markets outside the US. Tirzepatide is also commercialized as Mounjaro for adults with type 2 diabetes in the US. Semaglutide is commercialized as Wegovy for people living with obesity or for adults with overweight who also have weight-related medical problems and Ozempic for people with type 2 diabetes.
SURMOUNT-5 (NCT05822830) was a multi-center, randomized, open-label, phase 3b trial evaluating the efficacy and safety of Zepbound (tirzepatide) compared with Wegovy (semaglutide) in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea (OSA) or cardiovascular disease, who did not have diabetes. The trial randomized 751 participants across the US and Puerto Rico in a 1:1 ratio to receive maximum tolerated dose of Zepbound (10 mg or 15 mg) or Wegovy (1.7 mg or 2.4 mg). The primary objective of the study was to demonstrate Zepbound's superiority in percent change from baseline in body weight at 72 weeks compared to Wegovy.
Tirzepatide is a once-weekly dual GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist. Tirzepatide is a single molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones. Both GIP and GLP-1 receptors are found in areas of the human brain important for appetite regulation. Tirzepatide decreases calorie intake, and the effects are likely mediated by affecting appetite. Studies of tirzepatide in chronic kidney disease (CKD) and in morbidity/mortality in obesity (MMO) are ongoing. Lilly submitted data for tirzepatide in moderate-to-severe obstructive sleep apnea (OSA) and obesity and heart failure with preserved ejection fraction (HFpEF) and obesity to the US FDA and other global regulatory agencies earlier this year.
Tirzepatide was approved by the US?FDA as Mounjaro?for adults with type 2 diabetes to improve glycaemic control on?May 13, 2022, and as Zepbound?for adults with obesity or with excess weight and weight-related medical problems on?November 8, 2023. Tirzepatide is also commercialized as Mounjaro?in some global markets outside the?US?for adults with obesity or those who are overweight who also have a weight-related comorbid condition.?
Tirzepatide is the first and only approved dual GIP and GLP-1 receptor agonist treatment to reduce excess body weight and maintain weight reduction long term. Both Mounjaro and Zepbound should be used in combination with diet and exercise.
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe.
|