Petition Seeks More Ozempic, Mounjaro Trials

A petition filed by a Charles Ludlam (identifying information redacted) asks FDA to (1) require that additional clinical trials of Novo Nordisk’s Ozempic/Wegovy (semaglutide) and Lilly’s Mounjaro/Zepbound (terzepatide) be conducted on the loss of lean muscle mass, setting the ideal goal weight for patients and maintenance of weight loss and (2) modify and supplement the labels for the products about the stated issues. The petition says it was established in an Ozempic/Wegovy clinical trial that participants lost about 15 pounds of lean muscle on average, compared with 23 pounds of fat in a 68-week trial.

It says that the elderly already experience decreased muscle mass as they age and taking the weight-loss drugs could lead to an even greater loss of muscle mass. It calls on FDA to provide guidance in the drugs’ labels on how to prevent the loss of muscle mass or to restore it.