Why Zepbound Won FDA’s Approval
Zepbound (tirzepatide) was approved by the FDA on November 21, 2023, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or overweight and at least one weight-related comorbid condition, such as high blood pressure, high cholesterol, or type 2 diabetes.
The FDA approval was based on the results of two large, Phase 3 clinical trials, SURMOUNT-1 and SURMOUNT-2, which enrolled over 3,000 participants with obesity or overweight. In both trials, participants were randomly assigned to receive either Zepbound or a placebo for 72 weeks.
The results of the trials showed that Zepbound was significantly more effective than placebo at reducing body weight. In SURMOUNT-1, the average weight loss for participants who received the highest dose of Zepbound was 16.3%, compared to 2.4% for those who received placebo. In SURMOUNT-2, the average weight loss for participants who received the highest dose of Zepbound was 16.7%, compared to 2.6% for those who received placebo.
In addition to its weight-loss benefits, Zepbound also demonstrated the potential to improve a number of other health measures, including blood sugar control, blood pressure, and cholesterol levels.
Based on these positive results, the FDA determined that Zepbound is safe and effective for chronic weight management in adults with obesity or overweight and at least one weight-related comorbid condition.
Here is a summary of the key reasons why Zepbound was approved by the FDA:
- Significantly more effective than placebo at reducing body weight: In both SURMOUNT-1 and SURMOUNT-2, participants who received Zepbound lost significantly more weight than those who received placebo.
- Demonstrated the potential to improve a number of other health measures: In addition to its weight-loss benefits, Zepbound also demonstrated the potential to improve blood sugar control, blood pressure, and cholesterol levels.
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- Safe and well-tolerated: Zepbound was found to be safe and well-tolerated in the clinical trials. The most common side effects were nausea, vomiting, diarrhea, and constipation.
Overall, the FDA approval of Zepbound is a significant step forward in the treatment of obesity. This new medication has the potential to help millions of people achieve and maintain a healthy weight and reduce their risk of developing serious health problems.