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The agency also cites the absence of human testing

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It has been extensively studied for its role in promoting tissue repair, reducing inflammation, and supporting cellular regeneration across multiple organ systems

After 46 weeks of treatment: 0.6 mg dose: 6.2% mean body weight reduction 2.4 mg dose: 12.5% mean body weight reduction 3.6 mg dose: 13.2% mean body weight reduction 4.8 mg dose: 14.9% mean body weight reduction (all randomized) 4.8 mg dose: 18.7% mean body weight reduction (completers only) Placebo: 2.8% mean body weight reduction Among completers at the 4.8 mg dose, 68.8% achieved at least 10% weight loss, 67% achieved at least 15%, and 40% achieved at least 20% weight loss