Veru's muscle-preserving obesity drug enobosarm demonstrated an improved safety profile when combined with Novo Nordisk's Wegovy compared to Wegovy alone, according to Phase 2 clinical trial results released Wednesday. The 168-person study focused on addressing lean muscle mass loss, an emerging concern in obesity treatment that could increase frailty risk in older patients.
Reduced Gastrointestinal Side Effects
The safety analysis revealed that fewer participants receiving either of two tested doses of enobosarm with Wegovy experienced nausea or heartburn compared to those taking Wegovy alone. At the 3 milligram dose planned for Phase 3 testing, participants also experienced less diarrhea and vomiting than the Wegovy-only group.
However, the combination therapy showed one notable safety signal: more volunteers given enobosarm experienced elevated liver enzymes, though these levels subsequently dropped during the trial. At the selected 3 milligram dose, only one participant experienced elevated liver enzymes in what was described as a mild case where levels returned to baseline while still taking the drug.
Significant Muscle Mass Preservation
The trial's primary focus was demonstrating that adding enobosarm to Wegovy could reduce lean muscle mass loss compared to Wegovy alone. The study specifically enrolled people with obesity aged 60 years and older, addressing concerns about muscle loss in this vulnerable population.
Results showed that enobosarm combination therapy kept lean body mass loss to just 1.2%, significantly lower than the 4.1% lean body mass loss observed in the Wegovy plus placebo arm. Additionally, fewer participants taking enobosarm experienced substantial losses in stair-climb power, a key measure of physical function.
While the combination didn't increase overall weight loss compared to Wegovy alone, the preservation of lean muscle mass represents a potentially important clinical benefit, particularly as body composition emerges as a critical consideration in obesity treatment.
Phase 3 Development Strategy
Based on the trial data, Veru selected the 3 milligram daily dose for Phase 3 development, as the higher 6 milligram dose "did not provide any additional benefit." The safety data had remained blinded to both the company and researchers until participants completed an extension to the main 16-week trial period.
The company is also preparing a "novel, patentable, modified release oral formulation" for Phase 3 testing and potential commercialization. This new formulation will undergo Phase 1 trials in the coming weeks, with Veru believing the formulation patent could extend market exclusivity to 2045.
Market Context and Implications
The development addresses a growing concern in the obesity treatment landscape, as both Wegovy and Eli Lilly's Zepbound have been shown to reduce lean muscle mass alongside fat loss. This muscle loss could raise the risk of premature frailty, particularly in older patients who are already at higher risk for muscle wasting.
Veru shares rose significantly in morning trading following the announcement, though they remain well below previous highs. The stock traded around 60 cents per share, compared to $1.28 before the release of topline weight-loss data in January that showed enobosarm's body composition benefits without additional weight loss.
