testosterone undecanoate/d-alpha tocopherol (LPCN 2401) / Lipocine - LARVOL DELTA

Oral LPCN 2401, a Regulator of Myostatin, Rapidly Improves Body Composition in Men With Obesity (OBESITY WEEK 2025) - P2 | "These findings demonstrate that LPCN 2401, a bioidentical physiological myostatin modulator, may be a safe and effective therapeutic candidate for improving body composition in individuals with obesity, with rapid reductions in fat mass and concurrent increases in lean mass observed as early as 20 weeks. Based on these findings, further clinical evaluation of LPCN 2401 as an adjunct to incretin-mimetic based therapies for quality weight loss (predominantly through fat loss and preservation of lean mass/functionality) and weight maintenance (post cessation of incretin based therapies) has been initiated in an elderly population who are most vulnerable to loss of lean mass and functionality."

Genetic Disorders • Hepatology • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Musculoskeletal Diseases • Obesity • Orthopedics • AR

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2025 (Financial Times) - "Lipocine plans to initiate a proof-of-concept Phase 2 study for LPCN 2401 in obese and overweight GLP-1 eligible patients, with appropriate body composition and functional endpoints such as measured by stair climb performance with first patient dosing targeted for the third quarter of 2025."

New P2 trial • Obesity