Veru reported new safety data on Wednesday for its selective androgen receptor modulator (SARM), enobosarm. This drug aims to help patients with obesity lose fat while preserving muscle. It is being tested alongside GLP-1 receptor agonists, a common obesity treatment.
The data came from the Phase IIb QUALITY study. The study showed that patients taking enobosarm plus Novo Nordisk’s Wegovy (semaglutide) experienced fewer gastrointestinal (GI) side effects than those taking Wegovy alone. These results have encouraged Veru to start planning a Phase III trial.
QUALITY enrolled 56 patients aged 60 and older in each of three groups. One group took a 3-mg dose of enobosarm daily with Wegovy, another took 6 mg daily with Wegovy, and the third took a placebo with Wegovy. In January, Veru announced that patients on the combination lost 27% more fat and had 71% less lean muscle loss than those on Wegovy with placebo.
At that time, some experts were cautious. They noted that detailed data on side effects was missing and raised concerns about safety.
Daniel Drucker, an endocrinologist at Mount Sinai Hospital in Toronto, told FirstWord that safety concerns would be closely watched. He said, “The last thing you want is to treat one problem and cause another.”
The latest safety results from QUALITY may ease these concerns. Instead of increasing side effects, enobosarm nearly halved the number of GI problems. Patients on Wegovy with placebo reported 32 GI adverse events such as nausea, diarrhea, acid reflux, constipation, and vomiting. In contrast, those on Wegovy with the 3-mg dose of enobosarm reported only 18 such events.
With these positive findings, Veru said it has asked the FDA for an end of Phase II meeting. This meeting is expected next quarter and will focus on designing the Phase III trial.
The planned Phase III study will be similar to QUALITY. Patients will take enobosarm along with a GLP-1 drug. However, the main measure will change. Instead of lean body mass, the primary endpoint will be the 24-week result of a stair climb test. This test will show how the combination affects physical function.
Secondary goals for Phase III will include measuring enobosarm’s impact on total lean mass, total fat mass, insulin resistance, and HbA1c after 24 weeks.
