nuBioAge, nuHx and Marius Pharmaceuticals Team Up for Collaborative GLP-1 Comparison Study in Male Patients

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.

About nuBioAge

nuBioAge is a longevity science and wellness education network serving medical practitioners and allied health professionals focused on delivering patient-centric, evidence-based longevity medicine. With its comprehensive ecosystem of resources, nuBioAge empowers practitioners to leverage advanced pharmacy networks, state-of-the-art assessments and data, and leading longevity research, education and clinical implementation.

Physician-focused, science-backed, and dedicated to advancing transparent practices, nuBioAge is the go-to hub for practitioners committed to delivering clinical longevity medicine for improved healthspan and lifespan outcomes.For more information on how nuBioAge is redefining the future of longevity science, visit www.nubioage.com

About nuHx

nuHx is an extensive health assessment experience focused on whole body analysis through advanced biomarker testing and reporting. Their reporting results inform and assist physicians in crafting individual patient treatment plans that are based on a patients full health story rather than it's parts. Through their advanced testing, nuHx is able to identify risks through evidence-based data leading to preventative treatment that ultimately improves and optimizes a patients healthspan and longevity plan. For more information on how nuHx is individualizing health assessment experiences, visit www.nuhx.health.

About Progress Pharmacy

Progress Pharmacy is an independent pharmacy in West Palm Beach, Florida committed to providing personalized clinical care to patients seeking natural health and wellness alternatives and pharmacology solutions. With specific pharmacy clinicians trained in counseling each patient population, they aim to help patients find the right medicine for their health condition while working alongside research partners to develop expertly crafted compounds and therapies to best serve their market. For more information on how Progress Pharmacy is enhancing their patients quality of life through modern, personalized medicine, visit www.progresspharmacy.com

About Marius Pharmaceuticals

Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

About KYZATREX® (testosterone undecanoate)

KYZATREX® is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX® was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX® achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX® reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX® patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX® in males less than 18 years old have not been established.

Please see additional Important Safety Information for KYZATREX® below, including Boxed Warning for potential increased blood pressure, or visit www.kyzatrex.com.

Important Safety Information for KYZATREX^® (testosterone undecanoate)

Use
KYZATREX^® (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.

KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX^®

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

• If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
• If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
• Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

• Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
• If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
• Increased risk of prostate cancer.
• Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
• Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
• In large doses, KYZATREX may lower your sperm count.
• Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
• Swelling of your ankles, feet, or body (edema), with or without heart failure.
• Enlarged or painful breasts.
• Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by visiting www.mariuspharma.com.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:

1. Sargeant, J. A., Henson, J., King, J. A., Yates, T., Khunti, K., & Davies, M. J. (2019). A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors on Lean Body Mass in Humans. Endocrinology and Metabolism, 34(3), 247-262. https://doi.org/10.3803/EnM.2019.34.3.247
2. Rodriguez, P. J., Goodwin Cartwright, B. M., Gratzl, S., Brar, R., Baker, C., Gluckman, T. J., & Stucky, N. L. (2024). Semaglutide vs Tirzepatide for Weight Loss in Adults With Overweight or Obesity. JAMA Internal Medicine, 184(9), 1056-1064. https://doi.org/10.1001/jamainternmed.2024.2525
3. Srikanthan, P., & Karlamangla, A. S. (2014). Muscle Mass Index as a Predictor of Longevity in Older-Adults. The American Journal of Medicine, 127(6), 547. https://doi.org/10.1016/j.amjmed.2014.02.007
4. Griggs RC, Kingston W, Jozefowicz RF, Herr BE, Forbes G, Halliday D. Effect of testosterone on muscle mass and muscle protein synthesis. J Appl Physiol (1985). 1989 Jan;66(1):498-503. doi: 10.1152/jappl.1989.66.1.498. PMID: 2917954.

Contact Information:

Hayden Collier
[email protected]
www.nuhx.health

Marius Pharmaceuticals
Lilly Washburn
[email protected]

SOURCE NUBIOAGE LLC