Trevogrumab + Garetosmab + Semaglutide for Obesity

(COURAGE Trial)

This trial tests the safety and effectiveness of two experimental drugs, trevogrumab and garetosmab, combined with semaglutide (Wegovy®) for treating obesity. Part A assesses the safety of the drugs in healthy participants, while Parts B and C evaluate their potential for weight loss in individuals with obesity. The study will also monitor side effects and the body's response to these drugs. Individuals with a BMI of 30 or more, who have unsuccessfully tried to lose weight through diet, and do not have diabetes may be suitable for Parts B and C. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, contributing to advancements in obesity treatment.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research has shown that the combination of trevogrumab and garetosmab has been tested for safety, with no major safety issues found in recipients. Previous studies suggest that these drugs are generally well-tolerated when used together. However, health authorities have not yet officially reviewed the safety and effectiveness of these drugs. In contrast, the FDA has already approved semaglutide for other uses, such as weight management, indicating its well-known safety in humans. Overall, current data suggests the treatment appears safe, but ongoing studies aim to confirm this.¹²³⁴⁵

Researchers are excited about Trevogrumab and Garetosmab for obesity because these treatments represent a novel approach compared to existing options like lifestyle changes, medications such as orlistat, and GLP-1 agonists like semaglutide. Trevogrumab and Garetosmab are monoclonal antibodies that target specific pathways involved in fat accumulation and metabolism. Unlike traditional obesity treatments, which often focus on appetite suppression or calorie absorption, these drugs aim to modulate the body's underlying biological processes. This unique mechanism of action could potentially offer a more effective way to manage obesity, especially for individuals who have not responded well to conventional therapies.

Research has shown that combining semaglutide with trevogrumab, which targets the protein myostatin, can enhance weight loss in people with obesity. In this trial, some participants will receive this combination. Studies have found that it not only increases fat loss but also preserves muscle, which is often lost during weight loss. Specifically, it reduces muscle loss by 50%–80% compared to using semaglutide alone. This treatment aids in weight loss while maintaining muscle, which is crucial for overall health and metabolism. These findings offer promising evidence for the effectiveness of this treatment combination in managing obesity.¹²⁴⁶⁷