Lipocine Reports Positive LPCN 2401 Phase 2 Clinical Results

April 11, 2024

DENVER, Colo., Apr 11, 2024 (247marketnews.com)- Lipocine Inc. (NASDAQ:LPCN) results from a Phase 2 clinical trial including LPCN 2401, an oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, which 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.

“We are pleased with these results demonstrating that LPCN 2401 improves body composition by gaining lean mass and reducing fat mass,” stated 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.”

“Treatment with LPCN 2401 resulted in loss of fat mass and significant gains in lean mass in men with obesity. Although the reductions in total body weight were modest, this is very exciting as many popular interventions for treating obesity lead to reductions in lean mass, which can result in negative clinical outcomes,” added Dr. Jaime Almandoz, MD, Medical Director of the Weight Wellness Program and Associate Professor of Internal Medicine at UT Southwestern Medical Center.

Dr. Frank Greenway, MD, Professor, and Medical Director of the Pennington Biomedical Research Center of the LSU System, said, “The medical risk of obesity is associated with excess fat tissue. Men with obesity distribute their excess fat primarily in the abdominal area which is associated with a greater risk of cardiovascular disease. Despite this greater medical risk, men are under-represented in trials of medications to treat obesity. On the strength of these data, LPCN 2401 has the potential to fill an unmet medical need in men by reducing body fat, increasing lean mass and increasing bone mass to achieve a healthier composition of the body. As expected, this change in body composition is associated with healthier blood pressure and healthier blood sugar measurements.”

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