Lipocine announced results from a Phase 2 clinical trial which includes LPCN 2401, an oral proprietary combination of anabolic androgen receptor agonist and alpha-tocopherol, an antioxidant. The results showed significant improvement in body composition through decreased FM and increased LM or fat free mass – FFM – in patients with BMI greater than or equal to 30 – obese – or BMI greater than or equal to 27 with at least one weight-related comorbidity. LPCN 2401 treatment resulted in statistically significant body composition improvement in men. LPCN 2401 increased lean mass by 4.4% and decreased fat mass by 6.7%, reduced android fat by 4.1% and increased bone mineral content by 2.8%. LPCN 2401 was well-tolerated, adverse events similar to placebo.
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