Whether it’s Wegovy or Ozempic, weight loss drugs feel like they’re everywhere at the moment. That doesn’t look set to stop any time soon either, with the FDA announcing yesterday the approval of Zepbound, a weight-management injectable that may well snatch the crown from its semaglutide-based competitors.
Why was it approved?
The approval comes after two large-scale clinical trials: one of which involved obese or overweight adults with at least one weight-related condition, and the other involved those without diabetes. In both cases, Zepbound was taken in combination with a reduced-calorie diet and increased physical activity.
This is perhaps the most important aspect to note – none of these injectables are the “wonder drugs” that some have made them out to be. Zepbound, for example, has only been approved for use in those who have weight-related conditions such as high blood pressure or cholesterol, or Type 2 diabetes, alongside changes to diet and exercise.
None of that is to say that Zepbound was not found to be effective. In fact, quite the opposite – in both trials, after 72 weeks of taking the drug at one of three doses, all participants who received it and participated in diet and activity changes experienced a statistically significant reduction in body weight.
In the trial involving those without diabetes (but at least one other weight-related condition), 28.7 percent of all participants taking Zepbound lost up to 25 percent of their body weight, and those on the highest dose lost on average 18 percent of body weight. That’s pretty impressive stuff.
How does it work?
Like other weight management medications, Zepbound’s active ingredient, tirzepatide, is a synthetic alternative to hormones that control our metabolism and appetite. It’s already used in another approved drug, Mounjaro, to help improve blood sugar levels for people with Type 2 diabetes, alongside diet and exercise.
While semaglutide, the active ingredient in Ozempic and Wegovy, only mimics one hormone – glucagon-like peptide-1 or GLP-1 – tirzepatide mimics both GLP-1 and glucose-dependent insulinotropic polypeptide – (thankfully) shortened to GIP – which could explain why it’s so effective.
That effectiveness, however, can come at a cost. Zepbound has been found to have some fairly unpleasant side effects, ranging from gastrointestinal issues like diarrhea and vomiting to hair loss. It also comes with a whole host of warnings for people with existing medical conditions, such as pancreatitis, gallbladder problems, and acute kidney injury.
Is it just part of a trend?
If you’re wondering what’s with the sudden influx of weight management-related drugs, it may well have something to do with America’s obesity rates. According to the National Institutes of Health, nearly 1 in 3 American adults are overweight and just over 42 percent are obese. Many of those people also have a weight-related condition.
“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,” said John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a statement.
Whether Zepbound will have the same cultural impact that we’ve seen with other weight management drugs is yet to be seen, but in terms of clinical possibilities, Sharretts concluded, “In light of increasing rates of both obesity and overweight in the United States, [yesterday’s] approval addresses an unmet medical need.”