Eli Lilly and Company revealed the primary results of the SURMOUNT-5 Phase 3b open-label randomized clinical trial. In this study, Zepbound (tirzepatide) achieved a 47% greater relative weight loss than Wegovy (semaglutide). On average, participants using Zepbound experienced a 20.2% reduction in weight compared to a 13.7% reduction with Wegovy. At the 72-week mark, Zepbound surpassed Wegovy in both the main endpoint and all five critical secondary endpoints in the study involving adults with obesity or overweight issues and at least one associated medical condition, excluding diabetes.
“In response to the growing demand for obesity treatments, this trial was designed to assist healthcare providers and patients in making well-informed treatment choices,” explained Leonard C. Glass, MD, FACE, senior vice president of global medical affairs at Lilly Cardiometabolic Health. “We are delighted that today’s results highlight Zepbound’s superior weight reduction capabilities, helping patients achieve 47% more relative weight loss than Wegovy. As the only FDA-approved dual GIP and GLP-1 receptor agonist for obesity treatment, Zepbound is reshaping how millions manage this chronic condition.”
Furthermore, a notable secondary endpoint revealed that 31.6% of participants on Zepbound experienced at least a 25% weight loss compared to 16.1% of those on Wegovy.
The safety profile of Zepbound in the SURMOUNT-5 trial was consistent with previous research, with the most frequent side effects being mild to moderate gastrointestinal issues for both Zepbound and Wegovy.
Lilly plans to continue the analysis of the SURMOUNT-5 data, with findings to be published in a scientific journal and shared at a medical conference next year. Tirzepatide is marketed as Zepbound in the US for adults with obesity or overweight who have related medical conditions and as Mounjaro in various international markets. Furthermore, tirzepatide is sold as Mounjaro for adults with type 2 diabetes in the US. Semaglutide is marketed as Wegovy for people with obesity or for overweight adults with related health issues and as Ozempic for type 2 diabetes.
The SURMOUNT-5 trial (NCT05822830) was a multi-center, randomized, open-label Phase 3b study that assessed the effectiveness and safety of Zepbound (tirzepatide) compared to Wegovy (semaglutide) in adults dealing with obesity or overweight problems accompanied by conditions like hypertension, dyslipidemia, or obstructive sleep apnea (OSA), without diabetes. The trial involved 751 participants across the US and Puerto Rico, assigned in a 1:1 ratio to receive the highest tolerated dose of Zepbound (10 mg or 15 mg) or Wegovy (1.7 mg or 2.4 mg). The primary goal was to demonstrate Zepbound’s superior percentage change from baseline body weight at 72 weeks relative to Wegovy.
Tirzepatide is a weekly dual GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist. This molecule stimulates the body’s GIP and GLP-1 receptors, hormones crucial for appetite regulation. Tirzepatide’s effects likely arise from changes in appetite regulation, resulting in decreased caloric intake. Research on tirzepatide’s impact on chronic kidney disease (CKD) and morbidity/mortality in obesity (MMO) is ongoing. Earlier this year, Lilly submitted data for tirzepatide related to moderate-to-severe obstructive sleep apnea (OSA), obesity, and heart failure with preserved ejection fraction (HFpEF) to the US FDA and other global regulatory authorities.
Approved by the US FDA as Mounjaro for type 2 diabetes management on May 13, 2022, and as Zepbound for obesity on November 8, 2023, tirzepatide is also available as Mounjaro in different markets worldwide for adults with obesity or overweight accompanied by related conditions.
Tirzepatide represents the inaugural dual GIP and GLP-1 receptor agonist for long-term weight loss management. Both Mounjaro and Zepbound should be integrated with dietary and exercise plans.
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