FDA Approves a New Obesity Drug Poised to Dethrone Wegovy

There’s officially a new and fierce competitor for Novo Nordisk’s Wegovy (semaglutide) when it comes to weight loss. On Wednesday, the Food and Drug Administration approved the drug tirzepatide, developed by Eli Lilly, as a treatment for obesity. The weekly injectable drug will be sold under the brand name Zepbound.

Tirzepatide and semaglutide are both synthetic and longer-lasting versions of hormones key to controlling our hunger and metabolism. But whereas semaglutide only mimics the action of the GLP-1 hormone, tirzepatide mimics both GLP-1 and the hormone GIP. This combination is believed to increase the potential weight loss effect of the drug, an expected advantage that has been borne out in clinical research.

In the large-scale, placebo-controlled trials evaluated by the FDA for approval, tirzepatide was found on average to reduce people’s baseline weight by around 20% to 25% over more than a year—far surpassing the average weight loss for those who received a placebo in these trials and above the 15% average weight loss seen with high-dose semaglutide in similar trials.

That said, the average success seen with semaglutide has itself been far above the weight loss seen with previous medications. Many experts consider these drugs to represent the beginning of a new era in obesity medicine. Other treatments in development may provide even greater weight loss or offer their own distinct advantages, such as being taken as a pill.

“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 from the agency. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

Semaglutide was first approved for type 2 diabetes in 2017 under the brand name Ozempic, and was only later approved for obesity in a higher-dose formulation under the name Wegovy in 2021. Tirzepatide has taken a similar journey, first being approved for type 2 diabetes last year as the brand name Mounjaro, but will be sold as an obesity treatment as Zenbrand.

Whatever the name, these drugs are taken weekly via subcutaneous injection, with patients usually being tapered onto higher doses over time to reduce the risk and severity of side-effects.

These side-effects include gastrointestinal symptoms like nausea, diarrhea, vomiting, constipation, and stomach pain, but tend to wane over time. There have been other potential rare complications linked to their use, such as stomach paralysis, but these drugs are considered generally safe and tolerable. Another important consideration is that most people taking these drugs will likely need to remain on them indefinitely to maintain their weight loss.

Zepbound will be recommended for people who are obese (a body mass index over 30) or overweight (a BMI over 25) with one or more possibly weight-related conditions such as high blood pressure or type 2 diabetes. According to the FDA, about 70% of Americans are obese or overweight, with many in the latter camp having relevant conditions.

Important as these drugs might be, they haven’t come without some unexpected and potentially harmful consequences.

Popular demand and recurrent shortages of Wegovy have led to doctors prescribing Ozempic and Mounjaro off-label, which has impacted the care of people with diabetes taking them for their intended use. This lack of supply has also fueled the emergence of a gray and black market for these drugs. People are now buying custom-made and much cheaper sources of semaglutide and tirzepatide from compounded pharmacies, though with no guarantee of their safety or effectiveness. Elsewhere, some people have gotten hurt from taking counterfeit versions of semaglutide that likely contained other drugs such as insulin.

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