FDA Approves New Diet Drug Zepbound, a Version of the Diabetes Med Mounjaro
By Physician’s Briefing Staff HealthDay Reporter
THURSDAY, Nov. 9, 2023 -- 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.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted November 2023
Read this next
Greater Reduction Seen in Mortality With Bariatric Surgery Than GLP-1 RAs
MONDAY, June 10, 2024 -- Bariatric metabolic surgery (BMS) is associated with a greater reduction in mortality than glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment...
Overweight in Teens, Young Adults Tied to Cerebrovascular Disease in Women
THURSDAY, June 6, 2024 -- Being overweight in adolescence or early adulthood is associated with an increased risk for cerebrovascular disease among women, according to a study...
Study Looks at Links Between Cognition, Psychopathology, Weight in Preteens
WEDNESDAY, June 5, 2024 -- Lower cognition and greater psychopathology at baseline are associated with increased weight gain for children entering adolescence, according to a...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.