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FDA Approves Lilly’s Obesity Drug Zepbound

Tirzepatide injection becomes the first obesity drug that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1.

Eli Lilly and Co.’s Zepbound (tirzepatide) injection, the first obesity treatment that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound is indicated for adults with obesity or those who are overweight and also have weight-related medical problems such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease. 
 
The approval was based on results from the phase 3 SURMOUNT-1 and SURMOUNT-2 trials. In SURMOUNT-1, a study in 2,539 adults with obesity, or excess weight and weight-related medical problems not including diabetes, people taking Zepbound experienced substantial weight loss compared with placebo at 72 weeks. At the highest dose (15 mg), people taking Zepbound lost on average 48 lbs, while at the lowest dose (5 mg), people lost on average 34 lbs. (compared to 7 lbs. on placebo).
 
Additionally, 1 in 3 patients taking Zepbound at the highest dose lost over 58 lbs. (25% of body weight), compared to 1.5% on placebo, according to data not controlled for type 1 error. The average starting weight was 231 lbs.
 
While not approved to treat these conditions, in a clinical trial, people who dieted, exercised, and took Zepbound for the treatment of obesity or overweight with weight-related medical problems observed changes in cholesterol and reductions in blood pressure and waist size.

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