Zepbound (tirzepatide) is a weight loss medication that is indicated for adults with obesity – with a body mass index (BMI) 30 or higher – or for those who, in addition to being overweight (BMI 27 or higher), suffer from other associated health problems such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease, which has just been approved by the United States Food and Drug Administration (FDA).
Developed by the pharmaceutical company Eli Lilly, this medication is administered by injection and had previously been approved under the Mounjaro brand for the treatment of type 2 diabetes. Thanks to its new indication, it becomes part of the new arsenal of medications to combat excess weight, among which Ozempic and Wegoby, from the pharmaceutical company Novo Nordisk, and Mounjaro himself, which is also from Eli Lilly, stand out.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death, including heart disease, stroke and diabetes,” said Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders. and Obesity from the FDA’s Center for Drug Evaluation and Research. “In light of rising rates of obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
As explained by the pharmaceutical company, patients who receive Zepbound must follow a low-calorie diet and engage in greater physical activity, and it should not be administered together with other products containing tirzepatides or any GLP-1 receptor agonist medication. Furthermore, they warn that its effects have not been studied in patients with a history of pancreatitis, or with severe gastrointestinal disease, including severe gastroparesis.
Zepbound Efficacy in Weight Loss
The FDA has approved the drug based on the results of the phase 3 SURMOUNT-1 and SURMOUNT-2 clinical trials that have demonstrated its effectiveness. In the first, 2,539 adults with obesity, or excess weight, and medical problems associated with overweight that do not include diabetes participated. The average initial weight was 104 kilos.
Individuals taking Zepbound as an adjunct to diet and exercise experienced significant weight loss compared to placebo at 72 weeks. At the highest dose (15 mg), those taking Zepbound lost an average of 21 kilos, while at the lowest dose (5 mg), people lost an average of 15 kilos, compared to 3 kilos with placebo. Additionally, one in three patients taking Zepbound at the highest dose lost more than 26 kilograms, or 25% of their body weight, compared to 1.5% on placebo.
One in three patients taking Zepbound at the highest dose lost more than 26 kilos, or 25% of their body weight, compared to 1.5% in those taking placebo.
“Unfortunately, despite scientific evidence to the contrary, obesity is often viewed as a lifestyle choice, something people must manage on their own,” said Dr. Leonard Glass, senior vice president of business affairs. Lilly Diabetes and Obesity global physicians. “For decades, diet and exercise have been an option, but it is not uncommon for a person to have tried to lose weight 20 to 30 times with this approach. Research now shows that the body can respond to a calorie-deficit diet by increasing feelings of hunger and reducing feelings of satiety, making weight loss more difficult. “Lilly aims to eliminate misconceptions about this disease and transform the way it is managed.”
Zepbound is expected to be available in the US by the end of the year in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) priced at $1,059.87 dollars, which is approximately 20% less than semaglutide 2.4 mg injection for weight loss.
Tirzepatide is also under regulatory review for weight management in Europe, China, the United Kingdom and several additional markets. In Europe, the European Medicines Agency (EMA) has already approved tirzepatide (Mounjaro) to treat type 2 diabetes in adults whose disease is not well controlled.
Most common adverse effects of Zepbound
Eli Lilly has also warned of the most common side effects of Zepbound, which include nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion, injection site reactions, tiredness, allergic reactions, belching, hair loss and heartburn. , among others.
Additionally, the drug can cause serious side effects, such as:
- Serious stomach problems.
- Kidney problems (kidney failure). Diarrhea, nausea and vomiting can cause fluid loss (dehydration), leading to kidney problems.
- Gallbladder problems.
- Inflammation of the pancreas (pancreatitis).
- Serious allergic reactions, including swelling of the face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very fast heartbeat.
- Hypoglycemia or low blood sugar levels.
- Low blood sugar (hypoglycemia).
- Vision alterations in patients with type 2 diabetes.
- Depression or thoughts of suicide.
