Marketed under trade name Zepbound, drug found to produce statistically significant body weight reduction compared to placebo
The U.S. Food and Drug Administration (FDA) has approved a new drug to treat overweight or obesity.
The drug, tirzepatide (Zepbound), is an injection used for chronic weight management in adults with obesity (body mass index of 30 kg/m2 or greater) or overweight (body mass index of 27 kg/m2 or greater) who also have at least one weight-related condition. It’s designed for use in conjunction with a reduced calorie diet and increased physical activity. Approval to manufacture the drug was granted to Eli Lilly and Co.
“In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need,” John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research said in announcing the approval.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” Sharretts added.
According to the announcement, about 70% of American adults have obesity or overweight, and many of them have a weight-related condition such as high blood pressure, high cholesterol, or type 2 diabetes. For these adults, losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease.
The FDA has previously approved tirzepatide, the active ingredient in Zepbound, under the trade name Mounjaro for use along with diet and exercise to help improve glucose levels in adults with type 2 diabetes mellitus.
Zepbound’s effectiveness for chronic weight management was established using two randomized, double-blind, placebo-controlled trials involving adults with obesity or overweight and at least one weight-related condition. The trials, spanning 72 weeks, included 2,519 patients who received Zepbound at three different dosage levels and 958 patients who received placebo. In both trials patients who received Zepbound at all three dose levels experienced a statistically significant reduction in body weight compared to those who received placebo, and greater proportions of patients who received Zepbound achieved at least 5% weight reduction compared to placebo.
The FDA says Zepbound’s side effects can include nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, allergic reactions (typically fever and rash), burping, hair loss and gastroesophageal reflux disease, and that it should not be used in combination with Mounjaro or a GLP-1 receptor agonist.