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MOTS-c for Improving Insulin Sensitivity in Adults With ...

Mitochondrial-derived peptides (MDPs) are small peptides encoded by mitochondrial DNA that can act as signaling molecules. MOTS-c (mitochondrial open reading frame of the 12S rRNA type-c) has been reported to regulate insulin sensitivity and metabolic homeosta

Mitochondrial-derived peptides (MDPs) are small peptides encoded by mitochondrial DNA that can act as signaling molecules. MOTS-c (mitochondrial open reading frame of the 12S rRNA type-c) has been reported to regulate insulin sensitivity and metabolic homeostasis in preclinical studies, with skeletal muscle identified as a key target tissue and AMPK activation proposed as a downstream mechanism. Based on these findings, this trial is designed to test the hypothesis that MOTS-c can improve insulin sensitivity and cardiometabolic risk markers in humans with early metabolic dysfunction. The study includes a screening period (up to 4 weeks), a 12-week double-blind treatment period, and a 4-week post-treatment safety follow-up. Efficacy is assessed using a 75 g oral glucose tolerance test (OGTT)-derived insulin sensitivity index and standard metabolic endpoints (HbA1c, fasting glucose, lipids, body weight, and waist circumference). Safety assessments include adverse events, vital signs, ECG, and laboratory testing.

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The panel’s recommendations do not mean that the FDA has approved the six peptides, nor does it make these drugs immediately available through compounding pharmacies. “The misreading I’d most want to head off is people treating this as an FDA seal of approval,” Ash says. “It is important to note that a committee’s recommendation is not the same as FDA approval, and it does not mean these peptides have been proven safe or effective,” Jew says, noting that the panel’s recommendations are also not binding. “The FDA has the authority to overrule the recommendation if it deems that the evidence or public health considerations warrant a different decision.”

SOURCE / www.everydayhealth.com ↗