THURSDAY, Nov. 9, 2023 (HealthDay News) — A second injectable diabetes drug has been approved for weight loss in overweight and obese adults, the U.S. Food and Drug Administration announced Wednesday. The weight-loss drug Zepbound contains the same active ingredient, tirzepatide, as the diabetes drug Mounjaro.
Zepbound works by activating hormone receptors in the body to reduce appetite and food intake, the agency said. The drug is administered by injection once weekly.
The FDA approved the drug based on two 72-week clinical trials involving more than 2,500 patients who received varying doses of Zepbound and nearly 1,000 patients who got weekly placebo injections. Patients who got Zepbound at all three dose levels experienced a significant drop in weight compared with those in the placebo group. Greater proportions of patients who received Zepbound achieved at least a 5 percent weight reduction compared with those getting a placebo.
One trial involving adults without diabetes revealed that the highest approved dose of Zepbound helped people lose, on average, 18 percent of their body weight compared with those receiving placebo. The other trial, conducted in adults with type 2 diabetes, helped people lose an average of 12 percent of their body weight compared with those on placebo.
Side effects of Zepbound can include nausea, diarrhea, vomiting, constipation, stomach pain, fatigue, allergic reactions, burping, hair loss, and acid reflux.
Regulators are also keeping an eye on the drug’s potential links to thyroid cancer. The drug has been linked to thyroid C-cell tumors in rats, the FDA said, but it is unknown whether it has a similar effect in humans. Zepbound should not be used in patients with a family history of medullary thyroid cancer or in patients with multiple endocrine neoplasia syndrome type 2.
The approval was fast-tracked and received priority review by the FDA. Approval was granted to Eli Lilly.
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