FDA Approves Lilly’s Zepbound™ for Chronic Weight Management
The FDA approved Zepbound, a new weight loss drug from Eli Lilly. Zepbound is the first drug of its kind to activate both GIP and GLP-1 hormone receptors. It is approved for adults with obesity or overweight who also have weight-related medical problems, such as high blood pressure, high cholesterol, type 2 diabetes, obstructive sleep apnea, or heart disease. Zepbound is used with a reduced-calorie diet and increased physical activity. It should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines, and it has not been studied in patients with a history of pancreatitis or severe gastrointestinal disease.
“Obesity is a chronic disease that can result in serious health complications, including heart disease, stroke and diabetes. Despite our knowledge of obesity as a treatable, chronic disease, people living with obesity still face many challenges in their health and weight management journey,” said Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition. “New treatment options bring hope to the many people with obesity who struggle with this disease and are seeking better options for weight management.”
The FDA approval of Zepbound was based on results from two phase 3 clinical trials, SURMOUNT-1 and SURMOUNT-2. In SURMOUNT-1, 2,539 adults with obesity or overweight and weight-related medical problems (not including diabetes) were given Zepbound or a placebo in addition to diet and exercise. After 72 weeks, people taking the highest dose of Zepbound (15 mg) lost an average of 48 pounds, while those taking the lowest dose (5 mg) lost an average of 34 pounds. People taking the placebo lost an average of 7 pounds.
The FDA approval of Zepbound was based on results from two phase 3 clinical trials, SURMOUNT-1 and SURMOUNT-2. In SURMOUNT-1, 2,539 adults with obesity or overweight and weight-related medical problems (not including diabetes) were given Zepbound or a placebo in addition to diet and exercise. After 72 weeks, people taking the highest dose of Zepbound (15 mg) lost an average of 48 pounds, while those taking the lowest dose (5 mg) lost an average of 34 pounds. People taking the placebo lost an average of 7 pounds.
“Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice – something that people should manage themselves,” said Dr. Leonard Glass, senior vice president global medical affairs, Lilly Diabetes and Obesity. “For decades, diet and exercise have been a go-to, but it’s not uncommon for a person to have tried 20-30 times to lose weight with this approach. Research now shows that the body may respond to a calorie-deficit diet by increasing hunger and reducing feelings of fullness, making weight loss more difficult. Lilly is aiming to eliminate misperceptions about this disease and transform how it can be managed.”
Zepbound use may be associated with gastrointestinal adverse reactions, sometimes severe. The most commonly reported adverse events (observed in ≥ 5% of clinical trial participants) were nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection-site reactions, fatigue, hypersensitivity reactions, eructation, hair loss and gastroesophageal reflux disease.1 In studies, most nausea, diarrhea and vomiting occurred when people increased their dose – but the effects generally decreased over time.
In studies, gastrointestinal side effects were more common in people taking Zepbound than people taking placebo, and people taking Zepbound were more likely than those on placebo to stop treatment because of these side effects. The label for Zepbound includes a Boxed Warning regarding thyroid C-cell tumors. Zepbound is contraindicated in patients with a personal or family history of medullary thyroid carcinoma, in patients with Multiple Endocrine Neoplasia syndrome type 2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound.