The Next Breakthrough Weight-Loss Drug Just Neared FDA Approval

  • Tirzepatide, a new drug designed for diabetes, continues to show promise in weight loss trials.
  • Recent data found that people taking the drug lost almost 16% of their body weight in 16 months.
  • Manufacturer Eli Lilly expects an update on FDA approval in late 2023.

A potentially breakthrough drug called tirzepatide is getting closer to gaining FDA approval for weight loss, with new preliminary data from a clinical trial showing it helped people lose nearly 16% of their body weight in 16 months.

The drug, made by the pharmaceutical company Eli Lilly and sold under the brand name nun, was originally designed to treat diabetes. drew attention to dramatic weight loss resultswith an earlier trial published in June 2022, which showed participants lost 20% of their body weight, an average of 52 pounds, in about 16 months with once-weekly injections of the drug.

In it latest study Of 938 overweight or obese adult participants with type 2 diabetes, those taking tirzepatide lost an average of about 34 pounds, from an average starting weight of about 222 pounds. Those results are significant: Participants given a placebo lost just 7 pounds, or 3% of their body weight, in the same period.

Additionally, about 86% of participants taking the drug experienced at least 5% weight loss in the study.

The results of the latest study will be presented at the 83rd Scientific Session of the American Diabetes Association and will be submitted to a peer-reviewed journal.

Tirzepatide is also being submitted for FDA approval as a weight-loss drug, and Eli Lilly expects a process update in late 2023, according to a report. Press release.

In the meantime, patients can still access the drug; Since it has been approved by the FDA for diabetes, doctors can prescribe it to patients, even for a different purpose, if they think it will help.

A similar drug semaglutidewas approved by the FDA for weight loss in 2021. Its continued popularity has caused shortages and sparked a wave of generic versions of the drug called compound semaglutide (which are not FDA approved).

Tirzepatide works in a similar way to semaglutide, acting on a hormone called GLP-1 that controls appetite, but it also affects another hormone related to insulin. Some evidence suggests that it might be more effective than semaglutide, although the available data comparing the two were conducted only in people with diabetes and did not use the highest dose of semaglutide.

Side effects of both drugs are well documented, but are generally mild. About one in five patients reported nausea or diarrhea, and about one in 10 reported vomiting or constipation, according to the latest study of tirzepatide.

Like semaglutide, patients must continue to take tirzepatide to maintain weight loss results.

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