Pioneering study - how GLP-1 therapy combined with KYZATREX® impacts muscle mass and energy levels in male patients undergoing weight loss

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WEST PALM BEACH, Fla., Sept. 25, 2024 /PRNewswire/ -- nuBioAge, a longevity science and wellness network based in West Palm Beach, has announced a partnership between their new comprehensive assessment and research center, nuHx, and Marius Pharmaceuticals, the company behind KYZATREX® (testosterone undecanoate) CIII capsules, an FDA-approved oral testosterone treatment for men. Together, they aim to conduct a pioneering study that will measure the impact of GLP-1s on muscle mass in male patients using the treatment for weight loss.

In conjunction with muscle mass reduction being a known and documented side effect of GLP-1s, a decrease in energy levels and overall strength has been linked to men participating in GLP-1 therapies.1 While these reductions have been documented, there is currently no supportive treatment available for men struggling to maintain muscle mass and energy levels during GLP-1 therapy. nuHx and Marius Pharmaceuticals are partnering up to not only prove the cause-and-effect relationship between muscle mass reduction and energy loss as it relates to GLP-1s but also develop a first-of-its-kind treatment that leverages testosterone to counteract these effects and promote muscle growth during weight loss therapy.

Marius Pharmaceuticals will supply KYZATREX for this study in partnership with nuBioAge, who is responsible for assembling the study and data interpretation alongside nuHx, who will be performing the ongoing assessments for the patients participating in the study.
Patients will be recruited and supplied with medication through Progress Pharmacy, with study design and data analytics supported by Palm Beach Atlantic University's School of Pharmacy. Bryan Gard, PA-C, head of Gard Wellness Solutions, will oversee patient care as the lead specialist in Hormone Replacement Therapy (HRT) and weight loss.

This study is designed to evaluate how GLP-1 therapy combined with KYZATREX® impacts muscle mass and energy levels in male patients undergoing weight loss. By assessing key metrics such as muscle mass retention, testosterone levels, and VO2 max using advanced biomarker tools like PNOE, Dexascan, and other lab-based methods, the study aims to provide comprehensive insights.
nuHx offers a full spectrum of health assessments, making it the ideal setting to track and monitor these effects in male patients on GLP-1 therapy.

"GLP-1s are one of the most revolutionary therapies we have to treat obesity and overall metabolic disorders," said Franck Kacou, PharmD, co-owner of nuBioAge and Head Pharmacist at Progress Pharmacy. We can enhance the positive benefits of weight loss by improving Body Mass Index (BMI) and body composition in male patients to maintain muscle mass, strength, and energy levels through proper biomarker monitoring and TRT. As a result, we can directly impact and improve a patient's healthspan, quality of life, and longevity plan."

To further support the link between GLP-1s and muscle loss, a recent study showed that those taking Semaglutide lost on average 60% fat and 39% muscle mass. Patients on Tirzapetide lost roughly 25% muscle and 75% fat during treatment.2 In addition, lower levels of skeletal muscle mass (SMM) and physical strength performance have been linked to a higher risk of cardiovascular disease (CVD) as well as a higher risk of "all-cause mortality" over those with adequate muscle mass.3 To counteract muscle mass reduction, testosterone has proven for years it's link to muscle mass retention and growth through protein synthesis, making it a potential treatment solution for male GLP-1 patients.4

"This collaboration represents an exciting intersection of weight loss and testosterone therapy. By combining the benefits of GLP-1s with the muscle-building potential of testosterone, we believe we can offer a truly comprehensive approach to men's health,"
said Shalin Shah, CEO of Marius Pharmaceuticals. "Our goal is to ensure that men not only achieve weight loss but also maintain the strength and energy they need for a healthy life."

The study is set to start December 2024 at the nuHx headquarters in West Palm Beach and conclude May 2025 with published study results to follow. nuBioAge and its partner network will continue to pioneer unique studies like this one to contribute to the ongoing accessibility of physician education and knowledge in longevity treatment.
 
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