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November 10, 2023 : The Food and Drug Administration (FDA) has approved Eli Lilly’s Zepbound™ (tirzepatide) for chronic weight management, making it the first and only FDA-approved drug that activates both GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) hormone receptors.
Zepbound is a once-weekly injectable medication that is indicated for adults with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related medical problem, such as hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease.
The approval of Zepbound is based on the results of two Phase 3 clinical trials, SURMOUNT-1 and SURMOUNT-2, which evaluated the safety and efficacy of tirzepatide in over 2,500 adults with obesity or overweight with weight-related medical problems.
In both trials, tirzepatide was significantly more effective than placebo in promoting weight loss and improving blood sugar control. Participants who received tirzepatide lost an average of 15% of their body weight, compared to 2.5% in those who received a placebo. Additionally, tirzepatide was shown to reduce blood sugar levels and improve blood pressure and cholesterol levels.
Zepbound is generally well-tolerated. The most common side effects are mild to moderate and go away independently. The most common side effects include nausea, vomiting, diarrhea, and constipation.
The approval of Zepbound is a significant development for the treatment of obesity and overweight. It is the first and only FDA-approved drug activating GLP-1 and GIP hormone receptors. This dual activation is believed to be responsible for Zepbound’s superior efficacy in promoting weight loss and improving blood sugar control.
Zepbound is a powerful new option for the treatment of obesity and overweight with weight-related medical problems. It is expected to be a significant competitor to other weight loss medications, such as Wegovy and Ozempic.
The FDA’s approval of Zepbound is a positive development for treating obesity and overweight. Zepbound is a powerful new option expected to help many people lose weight and improve their health.
