Veru announced that its investigational drug, in combination with Novo Nordisk's weight-loss treatment semaglutide (Wegovy), preserved lean muscle mass in older patients with obesity, achieving the primary endpoint of a mid-phase trial.

The trial evaluated enobosarm, an oral selective androgen receptor modulator (SARM), in patients aged 60 and older, a population at increased risk for falls and fractures. Enobosarm selectively targets androgen receptors in skeletal muscle, which are involved in muscle development and maintenance.

Patients receiving enobosarm combined with Wegovy experienced a 71% smaller reduction in lean muscle mass on average compared to those receiving Wegovy alone over 16 weeks. Additionally, the combination group exhibited a more pronounced reduction in fat mass.

The extension phase is investigating whether enobosarm can mitigate weight and fat regain after Wegovy discontinuation over 12 weeks. Safety findings are expected to be disclosed in April, following completion of the study's extension phase.

"The expectation is that when patients are treated longer with enobosarm, which results in greater loss of adiposity, there would also be a profoundly greater weight reduction than with semaglutide (Wegovy) alone," noted Chief Scientific Officer, Gary Barnette in a press release.

Veru reported that the findings were consistent with prior studies of enobosarm, previously investigated for muscle wasting in cancer patients.

In the mid-phase study, 19.4% of patients on the enobosarm-Wegovy combination experienced a ≥10% loss in stair climb power, compared to 42.6% of those receiving Wegovy alone. A late-phase trial will further assess the drug's impact on stair climb power in older patients.