Enobosarm + Semaglutide for Obesity

(PLATEAU Trial)

This trial aims to study the effect of enobosarm, a selective androgen receptor modulator, on total body weight in individuals medically prescribed semaglutide for weight loss. Participants will receive either a combination of enobosarm and semaglutide or semaglutide with a placebo. The trial is suitable for individuals aged 65 or older with a BMI of 35 or higher who are willing to continue semaglutide treatment for up to 476 days and can complete a stair climb assessment.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

The trial does not specify if you need to stop taking your current medications, but you must continue taking semaglutide if you are already using it for weight reduction. If you have been on testosterone or similar agents, a 30-day period without these medications is required before joining the trial.

Research has shown that using enobosarm and semaglutide together is generally safe and well-tolerated. Studies indicate that enobosarm does not worsen the side effects of semaglutide. It also helps maintain muscle mass, so patients taking both drugs lose less muscle compared to those taking only semaglutide. This suggests that adding enobosarm does not increase risk.

Semaglutide, often used in weight-loss studies, has a strong safety record. It aids in weight loss and is usually well-tolerated. Common side effects include nausea and diarrhea, but these are typically mild.

Most treatments for obesity involve lifestyle changes or medications that focus on appetite suppression or fat absorption. But this investigational treatment pairs enobosarm, a selective androgen receptor modulator, with semaglutide, an existing weight management drug, creating a unique combination that may enhance muscle mass while promoting weight loss. Researchers are excited because enobosarm targets muscle receptors, potentially helping to preserve or increase lean body mass, which is a challenge with many current weight loss treatments. This dual approach could offer a more comprehensive benefit, addressing both weight loss and muscle health, which is not typical with existing obesity medications.

This trial will evaluate the combination of enobosarm and semaglutide for obesity. Research has shown that adding enobosarm to semaglutide can lead to more fat loss than using semaglutide alone. In those using this combination, all weight lost came from fat, preserving muscle mass. Another study found that individuals with a high body mass index (BMI of 35 or more) experienced significant weight loss, with 65.4% losing at least 5% of their body weight. Enobosarm also helps maintain muscle mass, which is crucial for strength during weight loss. Overall, using enobosarm and semaglutide together appears to effectively reduce body fat while preserving muscle. Participants in this trial will receive either the combination of enobosarm and semaglutide or semaglutide with a placebo.¹⁶⁷⁸⁹