Veru (VERU) Study Result summary

Study background and rationale

• GLP-1 receptor agonists are effective for weight loss but cause significant lean mass loss, especially concerning for older adults with low muscle reserves.

• Enobosarm, an oral selective androgen receptor modulator, was developed to preserve muscle and augment fat loss in older patients on GLP-1 therapy.

• FDA's new guidance emphasizes the importance of reducing adiposity while preserving lean mass in weight reduction therapies.

• The target population is older adults with obesity or overweight, particularly those at risk for sarcopenic obesity and frailty.

• Muscle loss in this population increases risks of falls, fractures, and loss of independence.

Study design and objectives

• Phase IIb QUALITY study was a multicenter, double-blind, placebo-controlled, randomized, dose-finding trial in 168 overweight or obese patients over 60 receiving semaglutide (Wegovy).

• Patients randomized to enobosarm 3 mg, 6 mg, or placebo, all starting GLP-1 therapy.

• Primary endpoint: change in total lean body mass at 16 weeks (measured by DEXA); key secondary endpoints: changes in fat mass, total body weight, and physical function (stair climb test).

• Study population: 31% male, 69% female; 80% aged 60–70; 48% non-white.

Efficacy results

• Enobosarm plus semaglutide led to a statistically significant 71% reduction in lean mass loss versus placebo plus semaglutide at 16 weeks (p=0.002).

• Enobosarm plus semaglutide resulted in a 27% greater fat mass loss than placebo plus semaglutide (p=0.096).

• Median proportion of weight loss due to lean mass was 9.4% with enobosarm vs 31.9% with placebo.

• Only minor differences in total body weight loss between groups; enobosarm improved body composition by preserving muscle and increasing fat loss.