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Lipocine Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity
LPCN 2401 treatment resulted in statistically significant body composition improvement in menIncreased lean mass (LM) by 4.4% and decreased fat mass (FM) by
About this update from Lipocine Inc.
[{"type":"text","content":"LPCN 2401 treatment resulted in statistically significant body composition improvement in menIncreased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7%Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8%Well-tolerated, adverse events (AEs) similar to placeboPotential for use in combination with incretin mimetics (GLP-1/GIP agonists and/or post GLP-1/GIP agonist) or as a monotherapy post discontinuationConference call and webcast at 8.30 a.m. ET todaySALT LAKE CITY, April 11, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced results from a Phase 2 clinical trial (NCT04134091) which includes LPCN 2401, an oral proprietary combination of anabolic androgen receptor agonist and α-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 ≥ 30 (obese) or BMI ≥ 27 with at least one weight-related comorbidity.\n\n \n \n \n \n \n \n\n \n\"We are pleased with these results demonstrating that LPCN 2401 improves body composition by gaining lean mass and reducing fat mass,\" said Dr. Mahesh Patel, President and CEO of Lipocine Inc. \"As an adjunct therapy to GLP-1/GIP agonists, we believe LPCN 2401 may improve muscle mass, quality, and functionality while maintaining weight loss and amplifying fat loss. Furthermore LPCN 2401 could help to attenuate collateral fattening and rebound fat/weight \"overshoot\" associated with discontinuation of GLP-1/GIP agonists. We look forward to meeting with the FDA to discuss the further development of LPCN 2401 as an aid to weight management interventions.\"\nThis multi-center prospective, blinded Phase 2 study included participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidity (e.g. hypertension, type 2 diabetes, dyslipidemia), a population consistent with FDA guidance for developing products for weight management. Participants were randomized to receive one of three treatments for 36 weeks: A) testosterone ester monotherapy capsule, B) T ester + α-tocopherol capsule (LPCN 2401), or C) matching placebo. Participants underwent Dual-Energy X-Ray Absorptiometry (DEXA) scans to measure body composition at baseline and Weeks 20 and 36. Safety and tolerability were ...