A new drug is helping mitigate one of the worst Wegovy side effects
Industry Buzz
The concern with anybody, no matter what form of weight loss they use, whether they are [utilizing] just diet and exercise or medications or even surgery, is you want to lose the fat mass and preserve the muscle.
—Mir Ali, MD
A new drug may help mitigate some of Wegovy’s side effects, such as loss of lean muscle mass. This drug, known as Veru’s enobosarm, is being studied as a complementary therapy alongside Wegovy.
Research is still preliminary and in the investigational stage; however, FDA feedback from this past September suggests enobosarm may be moving closer to a clearer regulatory path.
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Preserving lean muscle can promote physical health and weight loss, as “the more muscle you have, the more calories you burn in the resting state,” says Mir Ali, MD, a board-certified bariatric surgeon and the medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA. And, Dr. Ali adds, the easier it is to maintain weight for people who have reached a weight loss goal.
Losing muscle mass can be a large concern for people on weight loss drugs—or pursuing weight loss through other means—due to muscle’s importance for everyday function. “The concern with anybody, no matter what form of weight loss they use, whether they are [utilizing] just diet and exercise or medications or even surgery, is you want to lose the fat mass and preserve the muscle,” Dr. Ali says.
Veru recently presented promising results from a phase 2 clinical trial using enobosarm. In a press release, obesity expert and Veru consultant Dr. Louis Aronne, who was not directly involved in the study, described the clinical trial results as “very exciting.”[]
“Weight loss through any modality produces a loss of both lean and fat mass,” Dr. Aronne said. “The greater magnitude of weight loss seen with bariatric surgery and GLP-1 RA based drugs has produced an unmet medical need to preserve muscle and physical function in older patients receiving these treatments.”
He added that this was the first clinical trial to demonstrate both prevention of lean muscle loss and prevention of muscle function decline associated with weight loss in older patients using GLP-1 RA medications.
What's more—this past September, Veru announced that the FDA has now provided formal guidance supporting a clearer regulatory path for enobosarm—specifically as an add-on therapy to GLP-1 drugs like Wegovy. For the first time, the FDA indicated that “incremental weight loss” beyond what a GLP-1 alone can achieve is an acceptable primary endpoint for potential approval.[]
This signals growing regulatory recognition of the need for therapies that can preserve muscle, improve function, and help patients push past the well-documented weight-loss plateau seen with GLP-1s. Veru plans to advance enobosarm into a longer Phase 2b clinical trial in patients starting tirzepatide, with the goal of determining whether the drug can meaningfully enhance fat loss while maintaining lean mass.[]
Potential challenges
If enobosarm gains FDA approval in the future, access to the medication may be highly impacted by cost and insurance coverage.
“The big issue is, is it going to cost a lot? and is it going to be covered by insurance?’” Dr. Ali says. “These kinds of things always make it more, or less, accessible to people.”
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