As Miami-based Veru continues development of its enobosarm to prevent muscle wasting in patients being treated for obesity, among other conditions, the biopharma has conducted a survey showing that the side effect looms large in the minds of GLP-1 users.
The survey took place in May and comprised 1,000 adults in the U.S. taking GLP-1 receptor agonists (RAs).
When asked about how concerned they were about various side effects of the medications, 36% rated their perceived risk of experiencing muscle loss or weakness as “moderate,” “high” or “very high.”
Only 15% of respondents said they’d actually experienced muscle loss or weakness as a side effect of a GLP-1 as of the time of the survey, but Veru flagged two asterisks to that finding.
For one, nearly one-third of respondents aged 60 and up said they’d experienced the side effect, more than double the overall group’s percentage. And the results remain significant even when looking at the full cohort, per the company, since more than 80% of those surveyed were under the age of 60, a group in whom muscle loss can take months or years before becoming noticeable.
Many respondents reported taking steps that could help to mitigate muscle wasting due to GLP-1 usage. When asked about what dietary measures they’re taking to stay healthy, if any, 36% said they follow a high-protein diet, and more than half said they’ve upped their intake of lean proteins, along with other whole foods; as Veru noted, “protein is crucial for building and maintaining lean muscle mass.”
Most of those surveyed also reported engaging in some sort of regular exercise to stay healthy, including just under 40% who do strength or resistance training, another proven tool for mitigating lean mass decline.
With the survey respondents citing their doctors as the most popular resource for information about GLP-1s, Veru encouraged healthcare professionals to discuss muscle loss as a potential risk of starting GLP-1 treatment and educate patients about possible ways to mitigate that risk.
“It is evident that patients are aware of the substantial risk that GLP-1 RAs pose to their muscle mass and physical function,” Veru CEO Mitchell Steiner, M.D., said in a statement. “While diet and exercise are instrumental in combating lean mass decline, there is a mounting need—especially among the senior population—for treatments that can address the muscle loss which accompanies GLP-1 RAs. It is imperative that patients are presented with all the measures at their disposal to protect their long-term well-being.”
Veru is certainly hoping that, at some point down the line, its enobosarm will be included among those measures.
The drug has previously been tested as a method for reducing muscle wasting in patients being treated for cancer and virus-induced acute respiratory distress syndrome. Its current focus, however, is in combination with approved GLP-1 meds.
Phase 2b study results released earlier this year showed a statistically significant reduction in loss of lean mass in people who took the oral selective androgen receptor modulator alongside Novo Nordisk’s Wegovy: That group reported an average 1.2% reduction in lean mass after 16 weeks, compared to 4.1% in those taking only Wegovy. The drug was also linked to a greater reduction in total fat loss, a secondary endpoint of the study, with an average 10.9% reduction among the combo group versus 8.6% among the participants on placebo.
Veru has requested a meeting with the FDA to plan out a phase 3 study for enobosarm. As of late June, the request has been granted, though the company didn’t specify the meeting’s date in that announcement, which also included results from a maintenance extension of the phase 2b study showing that the company’s drug “completely prevented fat regain and preserved lean mass in both enobosarm dose groups compared to placebo” 12 weeks after patients stopped taking Wegovy.