Indianapolis, December 4, 2024 /PRNewswire/ – Eli Lilly and Company (NYSE: LLY) today announced topline results from the SURMOUNT-5 Phase 3b open-label randomized clinical trial.
Zepbound® (tirzepatide) demonstrated 47% greater relative weight loss compared to Wegovy® (semaglutide). On average, Zepbound helped achieve 20.2% weight loss, outperforming Wegovy’s 13.7% weight loss.
Over 72 weeks, Zepbound met the primary endpoint and all five key secondary endpoints, surpassing Wegovy in this study involving adults with obesity or overweight who had at least one weight-related medical condition and no diabetes.
Key Findings and Statement
Dr. Leonard C. Glass, Senior Vice President of Global Medical Affairs, Lilly Cardio-Metabolic Health, stated,
“With increasing interest in obesity medications, we conducted this study to assist healthcare providers and patients in making informed treatment decisions. We are thrilled that today’s results highlight Zepbound’s superior weight loss efficacy, helping patients achieve 47% greater relative weight loss compared to Wegovy. Zepbound, as the only FDA-approved dual GIP and GLP-1 receptor agonist for obesity, is redefining how millions manage this chronic condition.”
Additionally, 31.6% of participants on Zepbound experienced at least 25% body weight reduction, compared to 16.1% with Wegovy.
The overall safety profile of Zepbound in SURMOUNT-5 was consistent with earlier SURMOUNT trials. The most commonly reported adverse events for both Zepbound and Wegovy were gastrointestinal in nature and generally mild to moderate in severity.
Next Steps
Lilly will continue evaluating the SURMOUNT-5 results, which are planned for publication in a peer-reviewed journal and presentation at a medical conference next year.
About Zepbound® (Tirzepatide)
Tirzepatide is marketed under Zepbound® in the U.S. for adults with obesity or overweight and weight-related medical issues, and as Mounjaro® in other global markets.
For type 2 diabetes, tirzepatide is marketed as Mounjaro® in the U.S.
Similarly, semaglutide is marketed as Wegovy® for obesity and overweight with weight-related medical problems and as Ozempic® for type 2 diabetes.
SURMOUNT-5 Trial Details
SURMOUNT-5 (NCT05822830) was a multicenter, randomized, open-label, Phase 3b trial evaluating Zepbound® (tirzepatide) versus Wegovy® (semaglutide) in adults with obesity or overweight and at least one comorbid condition such as hypertension, dyslipidemia, obstructive sleep apnea (OSA), or cardiovascular disease, and no diabetes.
- Participants: 751 adults across the U.S. and Puerto Rico, randomized 1:1 to receive Zepbound (10 mg or 15 mg) or Wegovy (1.7 mg or 2.4 mg).
- Primary Goal: To demonstrate Zepbound’s superiority in percentage weight reduction from baseline after 72 weeks.
About Tirzepatide
Tirzepatide is a dual GIP and GLP-1 receptor agonist.
- Activates receptors for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1).
- Reduces calorie intake by regulating appetite via key brain areas.
Studies are ongoing to explore tirzepatide’s impact on chronic kidney disease (CKD) and morbidity/mortality in obesity.
In the U.S., tirzepatide received FDA approval as Mounjaro® for type 2 diabetes on May 13, 2022, and as Zepbound® for obesity and overweight on November 8, 2023. Globally, it is marketed as Mounjaro® for obesity with weight-related conditions.
Key Safety Warnings and Usage
Zepbound®:
- Helps adults with obesity or overweight achieve and maintain weight loss.
- Should be used alongside a low-calorie diet and increased physical activity.
- Not suitable for individuals with medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Potential side effects include:
- Gastrointestinal issues (nausea, diarrhea, vomiting).
- Kidney and gallbladder problems.
- Low blood sugar (especially when combined with insulin or sulfonylureas).
- Rare but severe allergic reactions.
For more details, visit www.zepbound.lilly.com or contact Lilly at 1-800-LillyRx (1-800-545-5979).
